RxPG News : Asthma

Breast-feeding babies staves off asthma risk

Mon, 25 Jul 2011 18:36:33 PST

( from http://www.rxpgnews.com ) Breast-feeding a baby for six months post birth can stave off their risk of developing asthma-related symptoms in early childhood, says a scientific study.

The study looked at the impact of the duration of breast-feeding and the introduction of alternative liquids or solids in addition to breast milk.

Generation R Study researchers from Erasmus Medical Centre in The Netherlands, used questionnaires to gather data about over 5,000 children, the European Respiratory Journal reports.

They ascertained in the first 12 months after birth whether the children had ever been breast-fed, when breast-feeding was stopped, and whether any other milk or solids were introduced.

Further questionnaires were completed when the children were aged 1, 2, 3 and 4 years to check whether they had any asthma-related symptoms.

The results showed that children who had never been breast-fed had an increased risk of wheezing, shortness of breath, dry cough and persistent phlegm during their first four years, compared to children who were breast-fed for more than six months.

The strongest links were seen with wheezing and persistent phlegm, as children were 1.4 and 1.5 times more likely to develop these symptoms if they had never been breast-fed.

Children who were fed other milk or solids during their first four months in addition to breast milk had an increased risk of wheezing, shortness of breath, dry cough and persistent phlegm during the first four years, compared to children who were exclusively breast-fed for their first four months.

Agnes Sonnenschein-van der Voort, researcher at Generation R, who led the study, said: 'These results support current health policy strategies that promote exclusive breastfeeding for 6 months in industrialised countries.'

--Indo-Asian News service

st/vd/vt

Mannose receptor plays a key role in allergic responses to cat dander

Thu, 10 Mar 2011 06:16:04 PST

( from http://www.rxpgnews.com ) The team of immunologists led by Drs Ghaem-Maghami and Martinez-Pomares in the University's School of Molecular Medical Sciences, and funded by the charity Asthma UK, have identified a cell component which plays a key role in triggering allergic responses to cat dander.

The discovery furthers our understanding of how the body's immune system identifies and reacts to allergens, which could pave the way in developing new ways of treating allergies.

The development is especially good news for the millions of people with asthma whose condition is often worsened by their allergy to airborne allergens from cat dander or house dust mite. Cat dander consists of microscopic pieces of cat skin which easily become airborne.

Dr Amir Ghaem-Maghami said: "There has been a sharp increase in the prevalence of allergies over the past few decades and allergic asthma among children has reached epidemic proportions in many industrialised countries, including the UK.

"Despite improvements in patient care, three people die every day in the UK from asthma, and most therapies target symptoms rather than curing the condition.

"Many people with asthma are highly sensitive to airborne allergens such as cat dander or house dust mite — in fact many studies have shown that up to 40 per cent of children with asthma are allergic to cat allergens.

"A better understanding of how the interaction between allergens and the immune system leads to allergy is vital if we are to develop more effective and efficient treatments for this debilitating condition."

Dr Elaine Vickers, Research Relations Manager at Asthma UK, says: "We are delighted to see the rapid progress that Dr Ghaem-Maghami and his colleagues are making in such a complex area of research.

"This is a great example of where Asthma UK's research funding is leading to a better understanding of asthma which could ultimately benefit thousands of people with both asthma and allergies."

Allergy is a disorder caused by the body's immune system reacting to usually harmless substances found in the environment, known as allergens. Believing itself under attack, the immune system produces a molecule called IgE, which eventually leads to release of further chemicals (including histamine) by certain immune cells which together cause an inflammatory response and the classic symptoms of allergy — itchy eyes, sneezing, runny nose and wheezing.

The Nottingham work, recently published in the Journal of Biological Chemistry, has focused on the role of the mannose receptor (MR), a receptor found on the surface of dendritic cells. These cells are among the first cells in the immune system that come into contact with allergens.

The team recently found that the MR binds to a wide range of allergens and plays an important role in the allergic response to house dust mite allergens. In their latest study they looked at the contribution of MR to allergy caused by a major cat allergen called Fel d 1.

They were able to prove that MR is needed for the body to recognise Fel d 1 as a potential foreign invader and for the production of IgE against Fel d 1. The discovery shows that MR plays a pivotal role not only in recognising allergens but also in provoking the body's allergic response to them.

MEMS sensor for remote monitoring of asthmatic patients

Sun, 24 Aug 2008 10:26:24 PST

( from http://www.rxpgnews.com ) An inexpensive web-enabled device for measuring lung function in patients with asthma and other disorders is being developed by researchers at Texas Instruments, in Bangalore, India, and co-workers. Writing in the International Journal of Biomedical Engineering and Technology, the team explains how the devise could allow physicians to monitor their patients remotely and quickly instigate medical attention in an emergency.

Spirometers are commonly used to measure lung capacity and the response of breathing during therapy. However, the widespread application of spirometers is limited in the developing world and in remote regions because of the high instrument cost of the instrument and a lack of specialist healthcare workers trained in its use.

Texas Instruments researcher N.C.S. Ramachandran is an expert in high-speed and low-power digital design and is working with professor of electrical engineering Vivek Agarwal of the Indian Institute of Technology, Bombay, India, on the development of an inexpensive and easy to operate spirometer that can be quickly hooked up to an internet connection through built-in web and data encryption software.

Simply monitoring cough and wheezing in asthma sufferers does not always provide an accurate assessment of the severity of their symptoms. Breathing tests carried out using a spirometer, on the other hand, are much more accurate and can provide a clear indication of whether or not medication is being effective.

The team has developed the device as a low-cost, portable spirometer built around a pressure sensor for detecting airflow. The sensor is fabricated using technology similar to that for manufacturing computer chips and is based on microelectromechanical system (MEMS). The MEMS spirometer can measures the flow and volume of air moving in and out of the patient's lungs.

The use of mass production techniques for making the MEMS sensor, means the device can be inexpensive (a few dollars per unit), small, and so portable. Embedding of the necessary electronics and software to allow it to connect to a computer and the Web make it ideal for remote monitoring by a patient's healthcare worker. "Not only can the remotely located patient consult a specialist," the researchers say, "the specialist too can instruct the patient for specific test procedures and treatment."

Inhaled treatments work better for asthmatic kids

Wed, 24 Jan 2007 10:53:36 PST

( from http://www.rxpgnews.com ) New York, Jan 24 - Inhaled treatments work better for children suffering from asthma compared to other methods of treatment, say scientists after comparing the effectiveness and safety of different medicines.

Although several medications are available to help children control asthma, clinical trials directly comparing them have not been conducted, reported health portal News Medical.

For the first time, researchers in the Childhood Asthma Research and Education Network of the National Heart, Lung, and Blood Institute - compared the effectiveness and safety of three different medicines for initial daily therapy for school-aged children with mild to moderate persistent asthma.

The researchers, who studied 285 children aged six to 14 years, found that after 48 weeks, inhaled corticosteroidsm, an asthma drug, were the most effective initial daily therapy for children with mild to moderate persistent asthma.

These results support the current asthma clinical guidelines, which recommend inhaled corticosteroids as the preferred initial therapy for children with mild to moderate asthma.

A dog in home may worsen asthma in children

Tue, 29 Aug 2006 21:08:00 PST

( from http://www.rxpgnews.com ) A new study from researchers at the Keck School of Medicine of the University of Southern California (USC) suggests that having a dog in the home may worsen the response to air pollution of a child with asthma. The study was published this week in the online edition of Environmental Health Perspectives, the journal of the National Institute of Environmental Health Sciences.

In "Dog Ownership Enhances Symptomatic Responses to Air Pollution in Children with Asthma," researchers looked at the relationship between chronic cough, phlegm production or bronchitis and dog and cat ownership among 475 southern California children with asthma who participated in the Children's Health Study, a longitudinal study of air pollution and respiratory health.

Children with dogs had significantly increased cough, phlegm production and bronchitis responses to the measured pollutants, including nitrogen dioxide, ozone, particulate matter and acid vapor. There were no increases of these symptoms in children who lived in homes without pets or who lived with only cats.

"Further work is needed to determine what it is about dogs that may increase an asthmatic child's response to air pollution," says Rob McConnell, M.D., professor of preventive medicine at the Keck School of Medicine of USC and lead author of the study.

McConnell and colleagues speculated that the increased response to air pollution from a dog in the home may really be due to increased levels of endotoxin, which is more common in homes where there is a dog.

"Cats are highly allergenic, and children with asthma are often allergic to cats," says McConnell. "Therefore if an allergen were enhancing the lung's response to air pollution, we'd be more likely to see an association with cats. But in this study we see an effect of air pollution in homes with dogs, so we think endotoxin exposure is a more likely explanation for our results than allergen exposure."

Endotoxin is a part of the cell wall of common bacteria in the environment. The authors note that inhaled endotoxin produces a marked inflammatory response in the lungs, and it may cause the airways of people with asthma to constrict. In previous studies, endotoxin has been shown to enhance the inflammatory effect of diesel exhaust particulate, inhaled highway aerosols and ozone in the lungs of experimental animals.

"There's experimental literature that shows both allergens and endotoxin interact with air pollution and increase the effect of each other," says McConnell. "But there's been very little study to see if these experiments have relevance for the general population of children with asthma."

McConnell cautioned that much more study is needed to specify why, exactly, children with asthma living in homes with dogs had an enhanced response to air pollution.

"There are other possible explanations for the findings," he says, "and actual measurements of home allergen and endotoxin, in addition to air pollution, would be important to evaluate further our hypothesis. It could also be that something only indirectly related to dogs could explain these results, for example that kids with dogs exercise outside more so they have more exposure to air pollution."

PEAK Trial: Inhaled steroids do not prevent chronic asthma

Thu, 11 May 2006 17:36:00 PST

( from http://www.rxpgnews.com ) Daily treatment with inhaled corticosteroids can reduce breathing problems in pre-school-aged children at high risk for asthma but they do not prevent the development of persistent asthma in these children, according to new results from the Childhood Asthma Research and Education (CARE) Network supported by the National Heart, Lung, and Blood Institute (NHLBI) of the National Institutes of Health.

Studies in older children and adults show that the most effective long-term control medicine for persistent asthma (symptoms more than two days a week or more than twice a month at night) is inhaled corticosteroids, which reduce airway swelling and help prevent asthma symptoms (e.g., asthma attacks). The Prevention of Early Asthma in Kids (PEAK) multicenter clinical trial, published in the May 11, 2006, issue of the New England Journal of Medicine, answers a question that pediatricians and researchers have been asking for years: Can medicine that treats the inflammation of asthma be used to prevent the disease if given early enough in at-risk patients?

"Asthma is an enormous public health problem, and this study was designed to see if we could stop the development of asthma in its tracks while the lungs are still developing in young children known to be at high risk," said NHLBI Director Elizabeth G. Nabel, MD. "Although this study shows that inhaled corticosteroids do not prevent chronic asthma, it provides clear evidence that inhaled corticosteroids benefit even some of our youngest patients."

A breathing disease in which the airways are inflamed, asthma is the most common chronic childhood illness in the United States. In 2004, nearly 9 million children had been diagnosed with asthma, including 1.5 million under the age of 5 years, according to the Centers for Disease Control and Prevention (CDC). In addition, children 4 years old or younger have the highest rates of hospitalization (59 per 10,000) and emergency room use (162 per 10,000) due to asthma of any age group. Overall, CDC estimates that more than 20 million Americans have been diagnosed with asthma.

Researchers have found that in most cases of chronic asthma, symptoms such as frequent coughing, wheezing (a whistling or squeaky sound during breathing) or shortness of breath begin during the first three years of life. Declines in lung function can occur this early as well. However, few studies have been conducted in children under 4 years of age.

In the PEAK trial, 285 children ages 2 to 3 years at high risk for asthma were randomly selected to receive either daily treatment of inhaled corticosteroid treatment (fluticasone propionate [Flovent] 88 mcg twice daily, using a metered-dose inhaler with a valve spacer and mask) or placebo for two years. All children in the study received additional medication to treat symptoms if they occurred. After two years, daily use of inhaled corticosteroids (or placebo) was stopped, and all participants were observed for an additional year to determine if the earlier treatment had lasting effects. Researchers report no significant differences between the participants in the treatment group and participants in the control (placebo) group during this observation period.

"We found that inhaled corticosteroids did not alter the natural course of disease in children who began daily treatment at 2 or 3 years of age," noted Theresa W. Guilbert, MD, lead author of the paper and assistant professor of pediatrics at the Arizona Respiratory Center of the University of Arizona College of Medicine in Tucson. "After a year without treatment, the children who had received inhaled corticosteroids had roughly the same frequency and severity of asthma-related symptoms and similar levels of lung function as the children who had not been treated."

During the two-year treatment period, however, children treated with the daily inhaled corticosteroids had significantly fewer and less severe asthma symptoms than their peers who were given placebo. For example, children treated with inhaled corticosteroids had on average 2 days of symptoms per month compared to 4 days of symptoms per month in the placebo group. They also had a lower rate of severe asthma exacerbations requiring additional treatment with oral corticosteroids and had less need for leukotriene receptor antagonists or additional inhaled steroid treatments.

The researchers found that the inhaled corticosteroids appeared to slow the growth of the children in the treatment group; however, this effect appeared to be temporary. The difference in growth rate was significant between the two groups during the first year of the study, but not during the second year of treatment. During the third-year observation period, the children who had been regularly treated with inhaled corticosteroids grew more quickly than the children who had not received inhaled corticosteroids. Overall, the children in the placebo group grew an average of 1.1 cm more than the children in the treatment group after two years, but by the end of the three-year study, the difference in average increase in height dropped to 0.7 cm.

"Another helpful outcome of the PEAK study is that it demonstrated that the asthma predictive index used in the study can help identify children who are at high risk for asthma-related problems," noted Lynn M. Taussig, MD, chair of the CARE Network, special advisor to the Provost, University of Denver and past president and chief executive officer of National Jewish Medical and Research Center.

The asthma predictive index showed that children at risk are those with frequent wheezing who also have either

* one of the following: eczema (a chronic skin disease characterized by itchy, inflamed skin), allergic reactions to airborne substances such as dust mites, or a parent with asthma; OR
* two of the following: food allergy, wheezing unrelated to colds, or elevated levels of eosinophils (a type of white blood cell).

"Perhaps the asthma predictive index can be used as a tool to help parents and pediatricians recognize vulnerable children early, in order to begin treatment and help the children have as many symptom-free, active and playful days as possible," said Taussig. The results of PEAK are similar to a large, five-year study of older children (ages 5 to 12 years), which demonstrated that inhaled corticosteroids are generally safe and effective for children with mild-to-moderate asthma. Like PEAK, the NHLBI-supported Childhood Asthma Management Program (CAMP) showed a slight reduction in growth rate among children taking inhaled corticosteroids only during the first year of treatment. Also like PEAK, the benefits of treatment stopped when the treatment was discontinued.

Guidelines from the National Asthma Education and Prevention Program recommend inhaled corticosteroids or another daily long-term control medication in older children and adults with persistent asthma to prevent symptoms and quick-relief medication such as inhaled bronchodilator to treat acute asthma symptoms if they occur. The results of the PEAK study provide strong support for extending the use of inhaled corticosteroids, for the same reasons, to pre-school children at high risk for asthma.

Telithromycin antibiotic could help in asthma attack

Sat, 15 Apr 2006 18:08:00 PST

( from http://www.rxpgnews.com ) A relatively new kind of antibiotic has been found to provide faster relief from an asthma attack, but more research is necessary before the drug can be prescribed, says a study.

Asthma, a chronic ailment that afflicts millions around the world, causes inflammation of the airways, or bronchi, and affects the way air enters and leaves the lungs, thereby disrupting breathing.

During an asthmatic attack, the airways of a patient become narrow, making it difficult to breathe. Doctors say steroids can help to treat the underlying lung inflammation associated with the condition, but they say that better drugs are needed to treat asthma attacks.

Sebastian Johnston at Imperial College, London, and colleagues tested telithromycin, an antibiotic by Sanofi-Aventis, on 278 adults with asthma, reported the online edition of New Scientist.

The antibiotic is typically used to treat chronic bronchitis and also appears to have anti-inflammatory properties.

Those who took the antibiotic reported twice as many symptom-free days as their counterparts who received the placebo. During the 10-day treatment period, those on telithromycin had a 40 percent reduction in symptoms as opposed to a 27 percent reduction seen in those on standard treatment alone.

They also showed a speedier recovery - about five days compared with eight days for the control group. Patients were considered to have recovered from their acute attack if they showed a 50 percent reduction in symptoms.

Medical experts however fear that antibiotic resistance would increase if physicians prescribe telithromycin improperly. They say that further trials of the drugs are necessary.

Antibiotics are not formally approved to treat asthma but some physicians prescribe them to asthma sufferers who show respiratory problems that could be due to bacterial infection.

Tomatoes, carrots can cut asthma risk

Sun, 19 Mar 2006 20:14:00 PST

( from http://www.rxpgnews.com ) Eating plenty of tomatoes, carrots and leafy green vegetable could help in reducing asthma risk in women, says a study.

Earlier research had found that asthma attacks in women were more than men due to hormonal changes, particularly during their monthly periods.

Researchers at the National Institute of Public Health in Mexico studied about 69,000 women and found lowered asthma risk in those who ate plenty of such vegetables, reported the online edition of medical journal Thorax.

Inhaled steroid may work better for normal-weight people

Thu, 23 Feb 2006 12:18:00 PST

( from http://www.rxpgnews.com ) As the nation's collective waistline has swelled in recent decades, rates of asthma diagnoses also have accelerated. Indeed, much research has affirmed a link between the two conditions.

But doctors also recognize that asthma may not behave the same way among people who have different body types. With a variety of asthma medications on the market, what kinds work best for lean people and what kinds work best for obese people? The answer may be different for each group.

A new study suggests that people who are overweight or obese may have better results with the prescription pill sold as Singulair than with a type of inhaled steroid, while leaner people may have better luck with an inhaled steroid, called beclomethasone and sold as beclovent, vanceril and other brand names. The findings appear in the new issue of the European Respiratory Journal.

"It is increasingly recognized that obese people are more prone to develop asthma, but there is no information about whether obesity influences people's responses to particular asthma medications," says lead author Marc Peters-Golden, M.D., professor of internal medicine and director of the Fellowship Program in Pulmonary and Critical Care Medicine at the University of Michigan Medical School.

"Our findings are the first to suggest the possibility that obesity might be a factor that influences how well asthmatics respond to particular medications," Peters-Golden says.

Singulair is the brand name of montelukast sodium and is sold by Merck & Co., which funded this study.

Researchers looked at data from four previous multi-center, randomized clinical trials from 3,073 patients with moderate asthma. The data included the patients' responses to Singulair/montelukast, a beclomethasone inhaled steroid and a placebo, and the participants' body mass index numbers, which placed them in the categories of normal, overweight and obese.

In general, the severity of people's asthma was found to be greater among those in the overweight and obese groups, which supports findings from other studies.

In addition, the inhaled steroid was found to be better than Singulair at increasing the number of asthma control days (ACD) among people in the normal weight category. An ACD is defined as a day with no more than two puffs of an inhaler, no night-time awakenings and no asthma attacks.

On the other hand, the inhaled steroid resulted in a reduced effect in the percentage of ACDs among obese people in the study that is, the benefit of the inhaled steroid declined with increasing body mass index.

In contrast, the positive impact of Singulair did not decrease in obese and overweight people when compared to its impact on people of normal weight. The research also suggests that the higher a person's body mass index, the greater his or her response to Singulair compared to a placebo, a pill with no medicinal benefit. This is an indication, Peters-Golden says, that obese and overweight people may in fact respond better to this medication.

Still, he is not inclined to suggest that doctors change the way in which they prescribe medication not yet, anyway.

"Our study looks back at material from previous trials. I'd like to see a prospective study in which lean patients and heavy patients are enrolled at the outset, and you compare both types of medications in both groups," Peters-Golden says. If verified by other studies, this insight may help physicians to better tailor medication regimens to meet individual patient needs.

Peters-Golden also notes that much research about asthma and other conditions is exploring the possibility that genetic factors might explain individual variations in responses to medications. He says it is likely that a variety of factors, including genetic ones and acquired factors such as weight, combine in a complex and intertwined manner to influence a person's reaction to medications.

Information about Singulair/montelukast: This medication, usually taken once a day, is a type of leukotriene antagonist that is, it blocks leukotrienes in the body. Leukotrienes are chemicals in the human body that can affect the breathing passages. Information about the beclomethasone inhaled steroid: Beclomethasone is a steroid that prevents the release of substances in the body that cause inflammation. Inhalation of beclomethasone prevents asthma attacks and other conditions involving inflammations of the lung tissues.

Female foetus could increase expectant woman's asthma

Fri, 03 Feb 2006 15:38:00 PST

( from http://www.rxpgnews.com ) Asthmatic women pregnant with girls are more likely to experience severe asthma symptoms than those carrying a male foetus, says a study.

Michael B. Bracken and other researchers at Yale School of Medicine studied 702 pregnant women throughout southern New England who were trained to assess their lung function for 10-day intervals at selected points in pregnancy.

Lung function and a number of other factors that might influence severity of the mother's asthma were recorded automatically, reported science portal EurekAlert.

Asthma worsened in mothers with either male or female foetuses until about 30 weeks gestation, after which there was an improvement in lung function. However, throughout pregnancy, mothers with a male foetus had 10 percent better lung function.

"However, this difference due to sex is potentially important but needs to be placed in the context of other factors which have a greater impact on the severity of the mother's asthma, including inadequate medical management of asthma symptoms, and whether the mother was a smoker or not," an expert said.

The finding, published in the February issue of American Journal of Epidemiology, is one of the first and largest studies to investigate the effect of foetal sex on the severity of the mother's asthma, and one of the largest to investigate the effect of foetal sex on any disease of the mother, it said.

Asthma is one of the most common diseases associated with pregnancy. An upcoming study by the authors to be published this spring shows that eight to nine percent of pregnant women have a history of asthma.

Childhood Asthma Affecting More than Just Breathing

Wed, 26 Oct 2005 23:57:00 PST

( from http://www.rxpgnews.com ) Recent research has shown that kids with asthma may also be at risk for psychological problems such as depression, anxiety, and problems in their social lives including peer interactions. This study, recently published in the Journal of Child and Adolescent Psychiatric Nursing, is one of the first to examine relationships among asthma, anxiety and depression, and several aspects of social functioning in urban children.

Findings suggest that among children with and without asthma from urban environments, social functioning is related to both depression and anxiety. Specifically, children with higher levels of anxiety and/or depression were more likely to have poorer interpersonal relations with others, feeling as though other children do not like them, do not respect them, and/or do not want to play with them. They also may experience more stress associated with social interactions and have fewer friends than children without internalizing problems.

The results of this study reinforce the importance of appropriate mental health training for nurses and other health care providers who come into contact with children in urban community health centers, says the studys lead author, Jennifer Bender Berz.

As many as 9 million children in the United States have been diagnosed with asthma, making it one of the most common chronic illnesses among children.

Omalizumab has long-term benefits in severe allergic asthma

Thu, 29 Sep 2005 20:49:00 PST

( from http://www.rxpgnews.com ) New long-term data show that Xolair® (omalizumab), a first-in-class monoclonal antibody for treating severe allergic asthma, helped patients to maintain control of their disease and was safe and well-tolerated in studies lasting more than three years. The data were presented at the European Respiratory Society (ERS) congress in Denmark, along with results from seven clinical studies showing that Xolair significantly improved the lung function of patients.

Long-term control of severe allergic asthma was demonstrated in a study spanning 180 weeks of observation. The design included a 32-week randomised, double-blind, parallel-group, placebo-controlled study, followed by a 96-week open-label extension and a further 52-week extension.

As a result, patients completing the study and both extensions had been treated for more than three years. Disease control was maintained throughout the follow-up period in Xolair patients, who exhibited lower than expected changes in lung function and reduced use of inhaled corticosteroids (ICS).1

"These results confirm that omalizumab potentially provides an important breakthrough in the fight against allergic asthma," said Prof. Marc Humbert of the Service de Pneumologie et Réanimation Respiratoire, Hôpital Antoine Béclère, Clamart, France. "Many people suffering from severe asthma have a substantially impaired quality of life and endure the constant fear that their next attack may prove fatal. By reducing exacerbations and the burden of disease, anti-IgE therapy offers a new approach to the treatment of this intractable condition."

Xolair manages asthma by targeting an underlying cause of allergic disease (up to 90% of asthma being allergic in origin2). It is designed to block the action of IgE, which is responsible for initiating the cascade of inflammatory symptoms such as airway constriction, mucus production, wheezing and shortness of breath. Xolair has been shown to decrease asthma exacerbations in some of the most difficult-to-treat patients whose condition remains inadequately-controlled despite the best conventional therapy, including inhaled corticosteroids, long-acting beta2-agonists and other controller medications.

The Committee for Medicinal Products for Human Use (CHMP) recently gave a positive opinion on initial marketing authorisation for Xolair, opening the way for approval by the European Commission and for the therapy to become available in EU countries.

More about the three-year study demonstrating efficacy and safety
In the 32-week placebo controlled study, 341 patients received Xolair (at least 0.016 mg/kg/IgE [IU/mL] every four weeks) or placebo. A total of 222 patients entered Extension 1 (96 weeks), 178 of whom continued into Extension 2 (52 weeks). Patients in the extensions maintained stable lung function (measured by forced expiratory volume in one second, or FEV1). Mean FEV1 was 2.24 litres at the start of Extension 1 and 2.26 litres at the end of Extension 2, indicating persistency of therapeutic benefit from Xolair. In addition, more than 80% of patients had good/excellent asthma control during the extensions. Patients receiving inhaled corticosteroids at the start of Extension 1 and remaining on the same steroid reduced their ICS use by an average of 11% between the start of Extension 1 and the end of Extension 2.

In this long-term study, the overall incidence of adverse events was similar in the Xolair and placebo groups during the 32-week placebo-controlled study and Extension 1 (i.e. approximately 80% in both groups). During Extension 2, 134 patients (75%) had at least one adverse event, most of which were mild to moderate in severity. Serious adverse events remained infrequent during the second extension (4.5%) and were deemed by the treating physician to be unrelated to Xolair.3

Improvements in lung function and quality of life
Pooled data were also presented from seven trials in which allergic asthma patients (93% of whom had severe persistent disease) received Xolair as an add-on to inhaled corticosteroids, with or without oral corticosteroids and long-acting beta2-agonists. Out of 4,308 patients in the studies, FEV1 data were available for 3,537 patients (Xolair 2,443; control 1,094). Among Xolair recipients, 29.1% increased their FEV1 by ≥200mL while 17.5% showed a ≥200mL decrease. In the control group, 26.4% had a ≥200mL increase in FEV1 and 26.1% had a ≥200mL decrease. This equates to a net benefit of 11.6% for Xolair patients versus 0.3% for control (P<0<0<0<80

CD23 structure revealed by NMR spectroscopy

Wed, 21 Sep 2005 19:22:00 PST

( from http://www.rxpgnews.com ) The structure of a molecule that regulates levels of the key antibody involved in allergic reactions and asthma, IgE, has been revealed by researchers from Oxford University and Kings College London. The study, published in Journal of Experimental Medicine, will help in the discovery of drugs to treat these two conditions.

IgE is thought to make certain cells of the immune system (mast cells) more sensitive to allergens, so lowering circulating levels of active IgE is a possible way of reducing the symptoms of allergies or allergic asthma.

The low-affinity receptor for IgE, called CD23, plays a dual role in the production of IgE. It can either inhibit or stimulate the antibodys production, depending whether it is attached or detached from the cell membrane.

Small molecules that bind to CD23 and prevent it from stimulating IgE production could be potential allergy and asthma treatments.

The researchers at Oxford and Kings used nuclear magnetic resonance (NMR) spectroscopy to discover the structure of CD23. Professor Brian Sutton from Kings, a co-researcher on the study, said: Currently a therapy that blocks IgE functioning is available, but it is expensive. Drugs that prevent the production of IgE might be a much cheaper way of treating allergies. Dr James McDonnell from Oxford University, who led the study, said: This is an important step forward in understanding some of the underlying mechanisms of the allergic response. Asthma UK funded part of the work. Dr Lyn Smurthwaite, their Research Development Manager said: The development of new therapies for people with asthma is an important part of Asthma UKs research programme'.

Bacteria in Household Dust May Trigger Asthma

Fri, 09 Sep 2005 15:30:00 PST

( from http://www.rxpgnews.com ) Researchers at NIEHS and the University of Iowa found a strong association between endotoxin levels and the prevalence of diagnosed asthma, asthma symptoms, asthma medication use, and wheezing. These relationships were strongest for bedroom floor and bedding dust. Households with higher endotoxin concentrations experienced higher prevalence of respiratory symptoms

Endotoxins are found in the cell wall of bacteria and are only released when bacteria ruptures or disintegrates. Because bacteria can be found everywhere in the home, the likelihood of their release is high. Once released, endotoxins can cause inflammation of the airways and lead to asthma symptoms.

Two research assistants visited each household, administered a detailed questionnaire, conducted a home inspection, and used a standardized protocol to collect samples. Dust samples were collected from bedroom, kitchen and living room floors, bedding, and upholstered furniture and assayed for endotoxin. A disease association analysis was performed to correlate endotoxin concentrations to specific health outcomes.

"When we analyzed the dust samples, we found that kitchen and living room floors had the highest concentrations of endotoxin," said Darryl C. Zeldin, M.D., a Senior Investigator at NIEHS. "However, when we looked at where the health impact of the dust was the most significant, we found that the likelihood of having recent asthma symptoms was nearly three times greater among individuals with exposure to high levels of endotoxin in the bedroom."

The researchers found that all dust samples contained detectable levels of endotoxin. The average concentration of endotoxin ranged from 80.5 units per milligram of dust on kitchen floors to 18.7 on bedding. Family room floors had endotoxin concentrations of 63.9 units per milligram of dust; sofas had concentration levels at 44.8; and 35.3 units on bedroom floors.

"Interestingly, endotoxin exposure worsens asthma symptoms in adults, regardless of whether an individual has allergies or not" said Peter S. Thorne, Ph.D., a researcher at the University of Iowa and lead author on the paper. "This suggests that exposure to endotoxin increases asthma risk even in non-allergic individuals."

Since the mid 1960s, researchers knew that house dust contains endotoxin, but it is only within the last five years that they began to understand the impact of household endotoxin on human health. Knowing what triggers asthma, whether it is endotoxins or something else, may help a physician better prevent or treat symptoms.

"This study implies that it is not just the concentration of the endotoxin that matters," added Dr. Schwartz, Director of NIEHS. "Understanding how factors such as duration of exposure, timing of the exposure, and genetic factors, contribute to the development of diseases like asthma will lead to new insights into how to prevent and treat this important disease." NIEHS is implementing new studies to better understand the role that the indoor environment plays in the development and severity of asthma.

Emotion processing centers in brain linked with asthma

Mon, 29 Aug 2005 22:15:00 PST

( from http://www.rxpgnews.com ) The mere mention of a stressful word like "wheeze" can activate two brain regions in asthmatics during an attack, and this brain activity may be associated with more severe asthma symptoms, according to a study by University of Wisconsin-Madison researchers and collaborators.

The study, which appears in the Proceedings of the National Academy of Sciences (Online, August 29, 2005), reveals a functional link between emotion processing centers in the brain and certain physiological processes relevant to disease.

UW-Madison psychology professor Richard Davidson, an expert on emotions; and UW-Madison medicine professor William Busse, an expert on asthma; are senior co-authors on the study. Melissa Rosenkranz, a graduate student at the UW-Madison Laboratory for Affective Neuroscience, is the lead author.

"While this study was small, it shows how important specific brain circuits can be in modulating inflammation," says Davidson, director of the affective neuroscience laboratory and the Waisman Laboratory for Functional Brain Imaging and Behavior. "The data suggest potential future targets for the development of drugs and behavioral interventions to control asthma and other stress-responsive disorders."

Previous studies and clinical evidence have shown that stress and emotional turmoil adversely affect people with inflammatory diseases like asthma. And signs of inflammation have been shown to affect the brain. But until now, nobody knew exactly what brain circuits were involved in these seemingly intertwined emotional and immune events or how the circuits might influence the severity of an acute asthma response.

Researchers used functional magnetic resonance imaging (fMRI) to scan the brains of six mildly asthmatic people who were asked to inhale ragweed or dust-mite extracts.

Subjects were then shown three types of words: asthma-related (such as "wheeze"), non-asthma negative (such as "loneliness") and neutral (such as "curtains"). Shortly after, researchers measured lung function in the subjects as well as molecular signs of inflammation in their sputum.

The fMRI scans revealed that the asthma-related terms stimulated robust responses in two brain regions--the anterior cingulate cortex and the insula--that were strongly correlated with measures of lung function and inflammation. The other types of words were not strongly associated with lung function or inflammation.

The two brain structures are involved in transmitting information about the physiological condition of the body, such as shortness of breath and pain levels, says Davidson, and they have strong connections with other brain structures essential in processing emotional information.

"In asthmatics, the anterior cingulate cortex and the insula may be hyper-responsive to emotional and physiological signals, like inflammation, which may in turn influence the severity of symptoms," says Davidson.

The researchers suspect that other brain regions may also be involved in the asthma-stress interaction.

Investigators Reveal a Key to Viral-Induced Asthma

Mon, 15 Aug 2005 17:59:00 PST

( from http://www.rxpgnews.com ) Researchers have discovered a new way to distinguish virus-induced asthma from that of allergen-caused disease based on a study of 59 asthma patients who were experiencing an acute exacerbation.

The investigators compared sputum cellular profiles of the 59 acute asthmatics against those of 45 controls. The control groups included 14 patients with stable asthma and no viral infection, 15 subjects without asthma but with a viral infection, and 16 healthy, uninfected persons. To establish infection status along with pulmonary status/history, participants completed common cold and asthma questionnaires, microbiological tests, and lung function and allergy (atopy) tests.

A respiratory virus was detected in 46 subjects, or 78 percent, of those with acute asthma.

In both children and adults, asthma exacerbations are caused by viral respiratory infections. Eighty three percent of the cases were infected with rhinovirus.

Expression of interleuken 10 (IL-10), a potent immunoregulator that functions to suppress immune responses broadly, was significantly increased in acute asthma with viral infections when compared with the control groups. Upon recovery from acute asthma, IL-10 gene expression returned to normal levels.

Consequently, according to the authors, IL-10 gene expression from airway cells appears to be a feature of virus-induced acute asthma. They said that their results reveal different mechanisms at work in virus-induced asthma patients than those described in allergen-induced asthma.

T lymphocytes cause airway thickening in asthma

Sun, 14 Aug 2005 14:30:00 PST

( from http://www.rxpgnews.com ) MUHC scientists have discovered that our body's own defense mechanism causes some of the most serious asthma symptoms. The study by MUHC researchers Dr. David Ramos-Barbón, Dr. Elizabeth Fixman and Dr. James Martin, published in a recent issue of Journal of Clinical Investigation (JCI), reveals that T lymphocytes--our body's defense cells--are responsible for the airway thickening, which increases the chances of a dangerous asthma attack. The discovery provides hope that new treatments might be developed to combat the disease, which currently has no cure.

Asthma symptoms are triggered by two factors: inflammation of the airways in the lungs, and thickening of airway muscle in the bronchi--an irreversible condition that doctors refer to as airway remodeling. Certain allergens--commonly dust and animal hair--can trigger inflammation, but the causes of airway remodeling (and the link between the two) have remained a mystery. MUHC researchers have now discovered that remodeling is actually caused by T lymphocytes--part of our body's own defense mechanism. "T lymphocytes are the traffic cops of the cellular world," says Dr. Ramos-Barbón. Where antigens are present, T lymphocytes can be found directing the body's defense mechanism, which in the case of asthmatics results in airway remodeling. "This is a natural response designed to protect the body from disease," notes Dr. Ramos-Barbón. "But in this case it actually promotes conditions that favour asthma, leading to increased symptoms such as coughing and difficulty breathing.

To make their discovery, researchers at the MUHC removed T lymphocytes from asthmatic rats, made them fluorescent by adding a jellyfish gene, and then transplanted them into non-asthmatic rats. "The fluorescence allowed us to track the movement of the T lymphocytes and determine their effect on the non-asthmatic rats," says Dr. Ramos-Barbón. Researchers were surprised to discover that the T lymphocytes moved directly to--and infiltrated--the airway walls of the non-asthmatic rats, causing extensive remodeling. Moreover, researchers discovered that the T lymphocytes must be in direct contact with the cells of the airway wall in order to cause remodeling.

"The next step is to develop mechanisms to interrupt this process and combat asthma," says Dr. Ramos-Barbón, who was presented the Eldon R. Smith Award for this research at the inaugural National Research Forum for Young Investigators in Circulatory and Respiratory Health, a major training and educational initiative of the CIHR Institute of Circulatory and Respiratory Health.

"This discovery is particularly exciting because it provides insight as to how the body's own CD4 T lymphocytes cause the thickening of the airway muscle, which increases the chances of a dangerous asthma attack. This research opens up new ways to prevent and treat asthma and its complications," said Dr. Bhagirath Singh, Scientific Director of CIHR's Institute of Infection and Immunity. "Continued research is key to advancements and hope for new diagnostic tests and treatments".

Inhale magnesium sulphate along with beta-2-agonists during asthma attacks

Wed, 20 Jul 2005 15:07:00 PST

( from http://www.rxpgnews.com ) Severe asthma attacks can be life threatening and intravenous magnesium sulphate is known to help, but inhaling nebulised magnesium sulphate can also improve lung function.

Asthma is a chronic disease of the lungs where people have periods where their breathing is stable, and other periods where it is restricted. These 'exacerbations' or 'attacks' can be mild or so severe that the person needs hospital treatment.

During most episodes people use inhaled beta-2-agonists, but in more severe cases these alone may not be enough to restore breathing to normal. The Cochrane Review Authors therefore searched the literature to examine the evidence regarding the use of inhaled magnesium sulphate as an additional therapeutic option.

They concluded that there was good evidence that nebulised magnesium sulphate was safe and effective and that it should be considered as an additional therapy along with beta-2-agonists.

"We also found that magnesium sulphate was most useful in situations where the exacerbation was severe," says lead author Maurice Blitz, who works in the Division of General Surgery, at the University of Alberta, Canada

Findings offer therapeutic potential for human asthma treatment

Wed, 06 Jul 2005 13:24:00 PST

( from http://www.rxpgnews.com ) Disruption of a single gene, Nrf2, plays a critical role in determining the susceptibility to asthma. A research team led by Shyam Biswal, PhD, at the Johns Hopkins Bloomberg School of Public Health found the absence of Nrf2 exacerbated allergen-mediated asthma in mice models. The studys findings, published in the July 4, 2005, edition of the Journal of Experimental Medicine, may hold therapeutic potential for the treatment of human asthma.

Asthma is a complex inflammatory disease of the airway characterized by airway inflammation and hyperreactivity. The incidence of asthma has doubled in the past two decades in the United States, affecting 20 million Americans. Controlling inflammation is a focus of asthma therapy. Inflammation occurs when certain cells migrate into the airways. These inflammatory cells release reactive oxygen species (ROS), causing the airway lining to swell and restrict. ROS is thought to cause lung tissue damage as well. ROS levels are normally offset by antioxidants in non-asthmatics. Recently, researchers have been hunting for novel genes that regulate inflammation with the hope of developing them as targets for the next generation of asthma drugs.

Suspecting that a defect in antioxidant response exacerbates asthma severity, the team of researchers began looking into the genetic factors that might contribute to this deficiency. In 2002, Biswals lab discovered Nrf2 acts as a master regulator of the majority of antioxidant pathways and detoxifying enzymes for environmental pollutants. This led researchers to consider the role of Nrf2 in lung inflammatory diseases caused by exposure to allergens. They found that the absence of the Nrf2 gene increased migration of inflammatory cells into the airways and caused an enhanced asthmatic response in mice. Nrf2 is critical for proper response to allergens in lungs and maintenance of a balance between ROS production. Antioxidant capability regulated by Nrf2 may be a major determinant of susceptibility to allergen-mediated asthma, says Biswal. Nrf2 regulated pathways seem to intervene inflammation at several points.

The findings provide a better understanding of the human bodys defense mechanisms to stress, which may hold clues to better control the inflammation process and improve control over asthma and its symptoms. Study coauthor Tirumalai Rangasamy, PhD said that the next step for researchers will be to look for molecular mechanism of regulation of asthmatic inflammation by Nrf2 and determine if there are alterations in the response of Nrf2 gene in asthma-prone humans. Future studies will determine the therapeutic potential of targeting Nrf2 for treatment of asthma.

Key milestone in antifungal treatment for severe asthma

Thu, 16 Jun 2005 18:00:00 PST

( from http://www.rxpgnews.com ) University of Manchester researchers announced today that they have reached a key milestone in their study of the antifungal treatment of asthma.

It is hoped that the study, by clinical researchers based at Manchester's Wythenshawe Hospital, will reduce steroid use and serious attacks requiring hospital intervention for asthma sufferers. It could also help those with cystic fibrosis and chronic sinusitis.

Severe asthma in adults affects 10 - 20% of the UK's 5m asthmatics, and skin tests indicate that up to 70% of these sufferers are allergic to one or more common fungi in the air.

Previous studies have shown the benefits of one antifungal drug [itraconazole or Sporonoxâ] for the asthma subgroup known as 'allergic bronchopulmonary aspergillosis' or 'ABPA'. The University of Manchester researchers are studying the more common association between fungal allergy and those with severe asthma who do not have ABPA. Volunteers are screened and, if testing shows allergy to one or more fungi, allocated itraconazole capsules or matching dummy capsules for 8 months. So far 26 patients (25% of the total required) have been enrolled.

Allergy to fungi is relatively common, affecting asthmatics, those with cystic fibrosis and others with chronic sinusitis (usually with nasal polyps). Fungi commonly implicated include airborne molds, such as Aspergillus, Cladosporium, Alternaria and Penicillium, with airborne fungal spores outnumbering pollen grains in outside air almost 1000-fold. Inside the home fungi are also very common, particularly in bedrooms and cellars, and compost is particularly rich in fungi.

The clinical study is funded by the charity The Moulton Trust as a grant to the University of Manchester. Its lead investigator Dr Robert Niven, of the North West Lung Centre, Wythenshawe Hospital, said: "We have few options for patients with severe asthma other than prescribing more steroids, and those we do have can have side effects worse than steroids themselves.

"Antifungal treatment for those sensitized to fungi may be a useful additional strategy to improve the breathing and overall health of these patients. Certainly our limited treatment experience with itraconazole suggests fewer admissions to hospital for asthma and reduced numbers of steroid courses."

Another rung on the Asthma ladder

Sun, 29 May 2005 16:26:00 PST

( from http://www.rxpgnews.com ) Results of a clinical study presented at a leading international medical congress show that Xolair® (omalizumab) halved the rate of severe asthma exacerbations and reduced the rate of hospital emergency visits by 44% in patients with inadequately controlled severe persistent asthma, who are at high risk of life-threatening attacks.1 Xolair also significantly improved patients' asthma-related quality of life, according to data from the same study presented at the centenary congress of the American Thoracic Society this week.

Xolair is a first-in-class therapy that is given by injection every two or four weeks and blocks the action of IgE, the antibody responsible for triggering the cascade of allergic symptoms in patients with diseases such as allergic asthma. It offers a novel therapeutic approach to the control of asthma symptoms such as wheezing and shortness of breath, even in the most difficult-to-treat patients whose condition remains poorly-controlled despite receiving the best available therapy.

A total of 419 such patients, aged 12-75, were recruited for a double-blind, placebo-controlled, parallel-group, multicenter study called INNOVATE to assess the effect of add-on Xolair therapy on the rate of severe asthma exacerbations and emergency visits.1 The participants all had reduced lung function and a recent history of clinically significant exacerbations, despite receiving step 4 therapy as defined in the GINA guidelines, including high-dose inhaled corticosteroids, long-acting beta2-agonists and other controller medication (including oral corticosteroids) if required.

Severe exacerbations halved
The severe exacerbation rate (i.e. where lung function measured by PEF or FEV1 was less than 60% of personal best, requiring systemic corticosteroids) and the rate of emergency visits (i.e. hospital admissions, emergency room visits and unscheduled doctor's visits) were calculated during the treatment phase. Results showed that add-on Xolair therapy significantly reduced both the severe exacerbation rate (0.24 vs 0.48, p=0.002) and emergency visit rate (0.24 vs 0.43, p=0.038) compared with placebo. The authors concluded: "Omalizumab should be considered as add-on therapy for patients with inadequately controlled severe persistent asthma who have a significant unmet need despite best available therapy."

The rate of clinically significant asthma exacerbations (i.e. those requiring rescue systemic corticosteroid therapy) was significantly reduced by 26% (p = 0.043), when adjusted for an observed imbalance in asthma exacerbation history prior to randomisation into the trial. Without taking this baseline imbalance into account, a similar magnitude of effect was seen (i.e. a 19% reduction) but this did not reach statistical significance.

Around 300 million people in the world have asthma,4 of whom an estimated 15 million suffer from severe persistent disease.5 Their health and quality of daily life are severely affected, and asthma is estimated to cause more than 180,000 deaths worldwide each year.Until now there have been few additional therapeutic options available for these patients.

A further analysis of data from the INNOVATE study evaluated the impact of Xolair treatment on patients' quality of life, measured by the Asthma QoL Questionnaire (AQLQ) (i.e. individual domains, overall score and clinically meaningful more than or equal to0.5-point improvement).2 Add-on Xolair therapy produced significantly greater improvements than placebo for each individual AQLQ domain (p0.002) and overall score (p less than 0.001). In addition, a significantly greater proportion of patients receiving Xolair achieved a clinically meaningful more than or equal to 0.5-point improvement from baseline in their AQLQ score than patients receiving placebo (60.8% vs 47.8%, p=0.008).

Well-tolerated in children
Another study presented at the ATS congress evaluated the long-term safety and tolerability of Xolair in children aged 6-12 years at entry, who were eligible to join a three-year multicenter, open-label extension on completion of a one-year clinical trial (28-week double-blind core trial and 24-week open-label extension).

The percentage of patients who experienced adverse events (AEs) in the core trial was similar in the Xolair and placebo groups (89.3%, n=201 and 87.2%, n=95 respectively). Of the 309 patients who entered the 24-week extension of the core trial, 244 (79.0%) experienced an AE. A total of 188 patients continued into the three-year extension, of whom 103 completed the study. Of the 85 patients who discontinued, the majority withdrew consent due to study duration and maintaining study commitments.

Xolair was generally well-tolerated and most AEs were mild to moderate in severity. When evaluated by 28-week increments, the incidence of AEs was generally comparable or lower than that seen in the 28-week core trial. No AEs suggestive of immunological reactions were reported. Overall, there were 13 AEs that investigators suspected were drug-related. There were eight serious AEs of which only one (dyspnea) was considered to be drug-related. No evidence of clinically significant changes in vital signs, spirometry or laboratory parameters, including platelets, were observed following Xolair treatment.

Xolair was launched in the US in July 2003, and is also approved in Australia, Brazil, Canada, Dominican Republic, Guatemala, Israel, New Zealand and Venezuela. It has been developed under an agreement between Novartis Pharma AG, Genentech, Inc., and Tanox, Inc. The European Medicines Agency (EMEA) is due to announce its decision on Xolair approval later this year.

The foregoing release contains certain forward-looking statements that can be identified by terminology such as "could fulfill," "should be considered," "is due to," or similar expressions, or by discussions regarding the potential that Xolair will be approved for marketing, or regarding any potential revenues from Xolair. Such forward-looking statements involve known and unknown risks, uncertainties and other factors that may cause actual results with Xolair to be materially different from any future results, performance or achievements expressed or implied by such statements. There can be no guarantee that Xolair will be approved for sale in any market. In particular, management's expectations regarding commercialization of Xolair could be affected by, among other things, uncertainties relating to clinical trials; new clinical data; unexpected regulatory actions or delays or government regulation generally; the company's ability to obtain or maintain patent or other proprietary intellectual property protection; competition in general; government, industry and general public pricing pressures; as well as other risks and factors referred to in the Company's current Form 20-F on file with the US Securities and Exchange Commission. Should one or more of these risks or uncertainties materialize, or should underlying assumptions prove incorrect, actual results may vary materially from those anticipated, believed, estimated or expected. Novartis is providing the information in this press release as of this date and does not undertake any obligation to update any forward-looking statements contained in this press release as a result of new information, future events or otherwise

Cockroach Allergens Have Greatest Impact on Childhood Asthma

Fri, 08 Apr 2005 04:11:00 PST

( from http://www.rxpgnews.com ) New results from a nationwide study on factors that affect asthma in inner-city children show that cockroach allergen appears to worsen asthma symptoms more than either dust mite or pet allergens. This research, funded by the National Institute of Environmental Health Sciences (NIEHS) and the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health, is the first large-scale study to show marked geographic differences in allergen exposure and sensitivity in inner-city children. Most homes in northeastern cities had high levels of cockroach allergens, while those in the south and northwest had dust mite allergen levels in ranges known to exacerbate asthma symptoms.

The study results are published in the March issue of the Journal of Allergy and Clinical Immunology.

"These data confirm that cockroach allergen is the primary contributor to childhood asthma in inner-city home environments," said NIEHS Director Kenneth Olden, Ph.D. "However, general cleaning practices, proven extermination techniques and consistent maintenance methods can bring these allergen levels under control."

Cockroach allergens come from several sources such as saliva, fecal material, secretions, cast skins, and dead bodies. People can reduce their exposure to cockroach allergen by eating only in the kitchen and dining room, putting non-refrigerated items in plastic containers or sealable bags, and taking out the garbage on a daily basis. Other measures include repairing leaky faucets, frequent vacuuming of carpeted areas and damp-mopping of hard floors, and regular cleaning of counter tops and other surfaces.

NIH provided $7.5 million to researchers at the University of Texas Southwestern Medical Center at Dallas and seven other research institutions, including the Data Coordinating Center at Rho, Inc., for the three-year study.

"We found that a majority of homes in Chicago, New York City and the Bronx had cockroach allergen levels high enough to trigger asthma symptoms, while a majority of homes in Dallas and Seattle had dust mite allergen levels above the asthma symptom threshold," said Dr. Rebecca Gruchalla, associate professor of internal medicine and pediatrics at the University of Texas Southwestern Medical Center and lead author of the study.

"We also discovered that the levels of both of these allergens were influenced by housing type," noted Gruchalla. "Cockroach allergen levels were highest in high-rise apartments, while dust mite concentrations were greatest in detached homes."

While cockroach allergen exposure did produce an increase in asthma symptoms, researchers did not find an increase in asthma symptoms as a result of exposure to dust mite and pet dander. "Children who tested positive for, and were exposed to, cockroach allergen experienced a significant increase in the number of days with cough, wheezing and chest tightness, number of nights with interrupted sleep, number of missed school days, and number of times they had to slow down or discontinue their play activity," said Gruchalla.

While cockroaches are primarily attracted to water sources and food debris, house dust mites, microscopic spider-like creatures that feed on flakes of human skin, reside in bedding, carpets, upholstery, draperies and other "dust traps." Dust mite allergens are proteins that come from the digestive tracts of mites and are found in mite feces.

Researchers tested 937 inner-city children with moderate to severe asthma symptoms. The children, ages 5 to 11, were given skin tests for sensitivity to cockroach and dust mite allergens, pet dander, and mold. Bedroom dust samples were analyzed for the presence of each allergen type.

Asthma patients' immune systems respond differently with allergies

Sun, 03 Apr 2005 10:33:00 PST

( from http://www.rxpgnews.com ) Researchers from the University of Chihuahua in Mexico report that immune systems of patients with asthma responded differently to a common laboratory challenge, depending on whether their white blood cells had been obtained during a time when they were suffering from common season allergic rhinitis or when they were free of such allergic symptoms.

Asthma is a chronic obstructive inflammatory lung disease with symptoms including wheezing, coughing, chest tightness, and shortness of breath. Asthma attacks can be triggered by viral upper respiratory infections, exercise, extreme temperature condition, and chemical irritants and also by the same allergens that cause seasonal allergies to pollen or mold spore or perennial allergies to dust mites, cockroaches, feathers, animal fur and other allergens. In fact, the vast majority of patients with asthma also experience one or both of these forms of allergy, with the same symptoms of frequent sneezing, itchy eyes, runny nose and nasal stuffiness.

In people with and without asthma, the body's response to allergens is based in the leukocytes, or white blood cells, that rush to defend the body against foreign agents. The leukocytes produce cytokines that mediate and regulate immunity and inflammation to an immune stimulus. Because people with asthma and allergy share this common etiological pathway, they show different expressions of their disease with a wide variety of therapeutic responses. That's why Dr. Leal-Berumen's laboratory became interested in studying the different response of these cytokines in asthma patients when they were and were not experiencing allergies.

The study involved 10 patients with clinical diagnosis for allergic rhinitis, who also have or had had asthma. Peripheral blood leucocytes were obtained both during rhinitis symptoms and during a period when the patients were not experiencing rhinitis symptoms, then cultured with a type of prostaglandin, a substance that causes inflammation. In nine of the ten asthma patients, leucocytes produced a greater amount of the cytokine IL-5 when isolated during the no symptoms season, whereas five of the nine showed a greater production of IL-13, another cytokine, during the symptoms season. These results indicate that leucocytes from the same patient present different susceptibility to IL-5 and IL-13 production depending on the presence or absence of allergic rhinitis symptoms.

Dr. Leal-Berumen says the group now plans to study cell response to more specific allergens similar to what was done with the prostaglandin challenge. They believe these studies will contribute to a better understanding of asthma, allergy and other inflammatory disease and guide the pharmacogenetic development of new therapies.

Zileuton Shows Significant Benefit in Prevention and Chronic Treatment of Asthma

Sat, 02 Apr 2005 08:39:00 PST

( from http://www.rxpgnews.com ) Critical Therapeutics, Inc. (Nasdaq: CRTX), today announced that it has submitted a supplemental New Drug Application (sNDA) to the U.S. Food and Drug Administration (FDA) for the Company's investigational asthma drug ZYFLO(R) Filmtab(R) (zileuton tablets). Approval of the sNDA would allow Critical Therapeutics to begin marketing its version of ZYFLO in the United States.

"This is an exciting event that moves us one step closer toward our goal of becoming a fully integrated biopharmaceutical company," said Paul Rubin, M.D., president and chief executive officer of Critical Therapeutics. "We anticipate launching ZYFLO in the second half of 2005, contingent upon regulatory approval of our sNDA."

The FDA approved ZYFLO in 1996 for the prevention and chronic treatment of asthma in patients 12 years of age and older. Critical Therapeutics in-licensed worldwide rights to ZYFLO in March 2004 and to other formulations of zileuton for a range of inflammatory diseases and conditions in December 2003.

ZYFLO has been commercially unavailable since early 2004 when commercial supply was depleted. Critical Therapeutics is required to submit an sNDA for ZYFLO because it is changing the manufacturing process and transferring production of the zileuton active pharmaceutical ingredient and the tablet formulation to third-party sites.

"ZYFLO is the only asthma treatment that blocks the activity of the enzyme responsible for producing an array of inflammatory mediators, most notably leukotrienes," Dr. Rubin said. "We believe this novel mechanism will allow ZYFLO to occupy a unique position in the treatment of asthma."

Clinical supply of ZYFLO currently is available through an open-label Phase IIIb study for patients who previously used and benefited from ZYFLO and need it to control their asthma symptoms. For more information regarding the open-label study, please visit the related link.

ZYFLO is not indicated for use in the reversal of bronchospasm in acute asthma attacks, including status asthmaticus. For full prescribing information, please visit the related link.

Mometasone furoate Shows Substantial Improvement in Lung Function in Persistent Asthma

Fri, 01 Apr 2005 09:14:00 PST

( from http://www.rxpgnews.com ) Schering-Plough Corporation today announced that the U.S. Food and Drug Administration (FDA) has approved the use of ASMANEX® TWISTHALER® 220 mcg (mometasone furoate inhalation powder) for the first-line maintenance treatment of asthma as preventive therapy in patients 12 years of age and older.

Mometasone furoate is also the only inhaled asthma controller therapy approved for once daily initiation and management of asthma in patients previously treated with bronchodilators alone or inhaled corticosteroids. Clinical studies with Mometasone furoate have shown substantial improvement in lung function, decreased use of rescue medication, decreased incidence of nighttime awakenings and significant improvements in daytime symptoms such as coughing and wheezing.

"Mometasone furoate is a highly effective first-line therapy that offers health care professionals and their patients a once daily therapy to help prevent persistent asthma symptoms," said Harold Nelson MD, Professor of Medicine, Department of Medicine, National Jewish Medical and Research Center, University of Colorado Health Science Center in Denver, Colo.

In a clinical trial, Mometasone furoate showed substantial improvement in lung function and decreased albuterol (rescue medication) use compared with placebo, as evidenced by a 12-week, multicenter, randomized, double-blind, placebo-controlled study of 400 patients with persistent asthma previously dependent on inhaled corticosteroid therapy.

At endpoint, patients who received Mometasone furoate had a significant improvement in nighttime awakenings and daytime symptoms -- providing night and day relief.

The NAEPP (National Asthma Education and Prevention Program) asthma treatment guidelines recommend single-ingredient, low-dose inhaled corticosteroid as the foundation of therapy for mild persistent asthma management.

Asthma is a chronic inflammatory lung disease that affects a growing number of Americans each year. The number of cases has grown steadily in the past 20 years, making it one of the leading public health problems in the U.S.

As many as 20 million people suffer from asthma. On an annual basis, this leads to at least two million emergency room visits and more than 5,000 deaths. Additionally, this accounts for an annual direct cost of treatment of $9.4 billion and approximately 14.5 million missed work days. Asthma symptoms such as coughing, wheezing, and shortness of breath occur during the day and night, impacting multiple aspects of patients' lives. Daytime symptoms can affect activities ranging from exercise to going to school or work. Nighttime symptoms interfere with patients' ability to sleep.

Mometasone furoate was discovered and developed by Schering-Plough Research Institute and is currently approved for asthma treatment in more than 40 countries. Mometasone furoate, the active ingredient in Mometasone furoate, was first introduced in the U.S. in 1987 as the dermatologic ointment, ELOCON (mometasone furoate ointment) and in 1997 as the nasal spray,NASONEX (mometasone furoate monohydrate).

In clinical trials with Mometasone furoate, adverse events were generally mild to moderate in severity. The following incidence of common adverse experiences is based on double-blind data from ten placebo-controlled clinical trials involving a total of 2,809 patients previously maintained on inhaled steroids and/or bronchodilators (1,140 males, 1,669 females, age 12-83 years), who were treated for up to 12 weeks with the Mometasone furoate product, an active comparator, or placebo.

Adverse events were generally mild to moderate in severity and included headache, allergic rhinitis, pharyngitis, upper respiratory infection, sinusitis, oral candidiasis, dysmenorrhea, musculoskeletal pain, back pain, dyspepsia, myalgia, abdominal pain, and nausea.

Mometasone furoate offers an effective inhaled corticosteroid to control asthma symptoms in an easy to use device that was awarded the DuPont Award for innovation in packaging. The Mometasone furoate Inhaler employs an inhalation- driven device that does not use a propellant, thus eliminating the need for hand-breath coordination, and it provides patients with a numeric dose counter that provides a visual indication of the remaining doses.

Recommended starting dose of Mometasone furoate is one inhalation daily in the evening for patients previously treated with bronchodilators alone or inhaled corticosteroids. For patients previously maintained on oral corticosteroids, the recommended starting dose of Mometasone furoate is two inhalations twice daily.

Mometasone furoate is expected to be available in the U.S. in the autumn of 2005.

Association found between high body mass index (BMI) and asthma

Tue, 01 Mar 2005 17:34:00 PST

( from http://www.rxpgnews.com ) In a cohort of New Zealand children who were followed from birth to age 26, overweight, expressed as higher body mass index, was significantly associated with asthma wheeze in females, but not in males.

The investigators found that the association between high body mass index (BMI) and asthma occurred in females who became overweight during late adolescence and early adulthood.

At age 9, there was no evidence of an association, but by 26 it was statistically significant. Analysis of data was performed in 1,037 children at ages 9, 11, 13, 15, 18, 21, and 26. Information on asthma and measurements of lung function, airway responsiveness, and atopy (inherited tendency toward allergic reaction) were obtained on each of these occasions. At each age checked, investigators calculated the young person's age, height, and weight in light clothing without shoes to determine BMI. The association between raised BMI and asthma appeared to emerge in late adolescence, according to the investigators.

The participants were part of the Dunedin Multidisciplinary Health and Development Study which involved children (52 percent male) who were born between April 1971 and March 1973. At age 26, 980 (96 percent of the 1,019 living study members were still participating.

Pulmonary complications after nonthoracic surgery are more frequent than cardiac complications

Tue, 01 Mar 2005 17:34:00 PST

( from http://www.rxpgnews.com ) Of the approximately 45 million North Americans who will undergo nonthoracic surgery during the next year, over 1 million will experience a postoperative pulmonary complication, an event which could have enormous implications for both the patient and health care system. Canadian investigators checked 1,055 consecutive patients attending a presurgical admission clinic at a university hospital to uncover risk factors for pulmonary complications after elective nonthoracic surgery.

According to the authors, pulmonary complications after nonthoracic surgery are more frequent than cardiac complications and are associated with a greater increase in hospital length of stay. Of the 1,055 patients in the study, 28 (2.7 percent) suffered a postoperative pulmonary complication within 7 days after surgery.

Thirteen patients developed respiratory failure requiring ventilatory support, 9 contracted pneumonia, 5 had collapse of lung tissue (atelectasis) requiring bronchoscopic intervention, and 1 suffered a collection of air or gas in the pleural cavity causing the lung to collapse. One patient who had pneumonia subsequently died. The length of stays for patients with postsurgical pulmonary complications were almost 28 days, as contrasted with 4.5 days for patients who had no postsurgical complications.

The four factors associated with an increased risk for pulmonary complications following nonthoracic surgery were: age over 65; a positive cough test (meaning the patient continued to cough after taking a deep breath and providing a voluntary cough); placement of a nasogastric tube at the time of the operation; and long-duration anesthesia (2.5 hours or longer). The researchers called for steps to minimize perioperative intubation unless it is judged very necessary on clinical grounds.

Montelukast significantly reduced Asthma exacerbations in young children

Wed, 16 Feb 2005 19:33:00 PST

( from http://www.rxpgnews.com ) Montelukast, a leukotriene receptor antagonist, significantly decreased the rate of exacerbations and lengthened the time between exacerbations in 2- to 5-year-old asthma patients who suffered from intermittent symptoms. The researchers pointed out that montelukast significantly reduced by almost 32 percent the rate of exacerbations over 12 months, as compared with results from patients on placebo. The average rate of exacerbation episodes was 1.60 episodes per patient per year, compared with 2.34 for placebo. (Leukotrienes are biologically active compounds that function as chemical mediators. They have vasoactive properties that help regulate allergic and inflammatory reactions. Medical antagonists are designed to counteract specific functions.) According to the authors, asthma usually begins and has its greatest prevalence in children younger than 5 years.

This age group often has intermittent symptoms, which include long assymptomatic periods interrupted by episodes of asthma generally in association with the common cold. Viral infections, predominately with rhinovirus, account for up to 85 percent of childhood asthma exacerbations and daily symptoms. The investigators claim that there are usually minimal symptoms between episodes. The 1-year study directed at exacerbation control was conducted at 68 sites in 23 countries. It involved 278 children receiving low-dose montelukast once a day for 12 months, along with 271 young participants receiving placebo. According to the authors, montelukast delayed the median time to first exacerbation by approximately 2 months. It also significantly reduced the overall rate of corticosteroid use by almost 32 percent and the rate of inhaled corticosteroid use by almost 40 percent. However, although the use of montelukast reduced exacerbations in intermittent asthma, the investigators said that they do not necessarily advocate year-round regular treatment with the compound. They noted that since exacerbations tended to be seasonal, therapy should begin before the viral season when the exacerbation rate is high.

Role for the A1 adenosine receptor in protecting against asthma

Tue, 04 Jan 2005 19:35:00 PST

( from http://www.rxpgnews.com ) Levels of the signaling molecule adenosine are increased in the lungs of asthmatics, and elevations of adenosine correlate with the degree of airway inflammation, suggesting that adenosine may play a provocative role in acute asthma attacks. Therefore much research has been focused on drugs that may potentially interact with known adenosine receptors the activation of which can have proinflammatory or anti-inflammatory effects, depending on the receptor type. Theophylline, the most widely prescribed drug for the treatment of airway disease worldwide, is able to block both pro- and anti-inflammatory actions of adenosine, potentially decreasing its efficiency. Researchers are now focused on determining the role of each adenosine receptor so that they may design drugs to interact with specific receptors and reduce airway inflammation.

As described in a report in the January 3 issue of the Journal of Clinical Investigation, Michael Blackburn led a team of researchers at the University of Texas Health Science Center and the National Institutes of Health to examine the role of the A1 adenosine receptor (A1AR) in a mouse model of lung injury and inflammation in which these mice possess elevated adenosine levels.

Blackburn et al. show that mice lacking A1AR die shortly after birth from severe inflammatory lung disease, indicating that A1AR serves an anti-inflammatory and thus protective role in the development of lung inflammation. The findings are particularly relevant in light of the fact that drugs that block A1AR are currently being investigated as a potential treatment for asthma.

In an accompanying commentary, Stephen Tilley and Richard Boucher from the University of North Carolina discuss this study and the potential clinical benefits of blocking A1 receptors in the airways of asthma patients.

High-risk asthma patients reduce asthma medication use in days after hospitalization

Thu, 16 Dec 2004 16:37:00 PST

( from http://www.rxpgnews.com ) In a study of high-risk patients with severe asthma who were hospitalized for serious exacerbations, researchers showed that within 7 days of discharge their use of prescribed inhaled corticosteroids and oral steroids had fallen rapidly to approximately 50 percent of their prescribed dose. The investigators measured post-hospital adherence in 52 inner city asthmatics by means of electronic medication monitors, self-report, canister weight (for inhaled corticosteroids) and pill counts (for oral corticosteroids). The researchers noted that their results provided strong evidence that even under optimal conditions with free medications and intensive inpatient education, discontinuation of both inhaled corticosteroids and oral corticosteroids was common within 7 days of discharge from the hospital.

The participants were almost exclusively African-American with 65 percent (34 patients) being female, and almost half having a history of near-fatal asthma. For the most part, they were unemployed and unmarried. Asthma affects 15 to 20 million people in the U.S. Although effective medical therapies are available, the illness results in severe asthma exacerbations, causing 465,000 hospitalizations and 5,000 deaths per year.

Hospitalization and death related to asthma exacerbations are two to three times more likely among African-Americans and minority patients, according to the authors. The research appears in the second issue for December 2004 of the American Thoracic Society's peer-reviewed American Journal of Respiratory and Critical Care Medicine.