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June 4, 2008, 11:06 PM CT

Symbicort for treatment of asthma in children as young as 6

Symbicort for treatment of asthma in children as young as 6
AstraZeneca today announced that it submitted a supplemental New Drug Application (sNDA) to the U.S. Food and Drug Administration (FDA) for approval of a new indication for SYMBICORT® (budesonide/formoterol fumarate dihydrate) Inhalation Aerosol for the long-term maintenance therapy of asthma in pediatric patients ages 6 to 11 years old. SYMBICORT is currently approved for the long-term maintenance therapy of asthma in patients 12 years and older.

"Millions of children in the U.S. are affected by asthma1," said lead investigator Jeffrey Leflein, MD, Allergy & Immunology Associates of Ann Arbor, Michigan. "SYMBICORT could potentially offer another therapy option for the long-term maintenance of asthma in young children whose condition is not adequately controlled with inhaled corticosteroids alone".

The submission package is based on a robust clinical development program consisting of five active or placebo-controlled Phase III trials assessing the efficacy and safety of SYMBICORT pressurized metered-dose inhaler (pMDI) that included 1,446 children ages 6 to 11 years old with asthma.2 The proposed starting dose for children (80/9 mcg twice-daily) was studied in one pivotal randomized, double-blind, active-controlled, 12-week study that reviewed 256 children ages 6 to 11 years old with mild-to-moderate persistent asthma previously treated with inhaled corticosteroid treatment.3 In this study, SYMBICORT was in comparison to budesonide pMDI and formoterol dry powder inhaler.3 A second study evaluating this dose included 351 subjects ages 6 to 11 years old.4 Results from both studies demonstrated that SYMBICORT 80/9 mcg twice daily had a similar safety profile to one of the mono-components, budesonide;4,5 likewise, results from the first study also observed that SYMBICORT 80/9 mcg twice daily had a similar safety profile to its other mono-component, formoterol.5 The most common adverse events reported were headache, pyrexia, upper respiratory tract infection, nasopharyngitis, and pharyngolaryngeal pain.2 .........

Posted by: JoAnn      Read more         Source


June 1, 2008, 10:49 PM CT

Cold Medication Use in Young Children

Cold Medication Use in Young Children
significant number of adverse effects and several deaths, leading the FDA to recommend against their use for children less than two years old. Despite these concerns about safety and efficacy, there has been little research on patterns of cough and cold medicine use in very young children. Now, a new study from the Emergency Medicine Network (www.emnet-usa.org) led by Katherine O'Donnell, M.D. of Children's Hospital Boston reveals important new statistics about medicine use in children under the age of two.

As per the study, 1-in-3 children under the age of two with bronchiolitis (a lower respiratory tract infection linked to runny nose, cough, wheezing and/or difficulty breathing) had received over-the-counter cough and cold medicines in the week previous to visiting an emergency department.

This study identifies rates and predictors of cough and cold medicine use previous to the manufacturer recall of and FDA recommendations against use of these medications in children younger than two years of age.

"After the recall and labeling changes, it will be important to monitor for potential ongoing use of these medicines in young children and observe if parents or physicians are turning to other therapies in place of these medications," says O'Donnell.........

Posted by: JoAnn      Read more         Source


May 20, 2008, 9:39 PM CT

SYMBICORT in children with persistent asthma

SYMBICORT in children with persistent asthma
A new 12-week study2examined safety and efficacy measures of the maintenance combination asthma treatment, SYMBICORT (budesonide/formoterol fumarate dehydrate) Inhalation Aerosol,2 in treating mild to moderate persistent asthma in children ages 6 to 15 years old2 who were previously treated with an inhaled corticosteroid (ICS).2 Of note, the study included efficacy assessments of nighttime symptoms, nighttime rescue medicine use and rescue medication-free days in patients taking SYMBICORT in comparison to those taking formoterol dry powder inhaler (DPI) or budesonide pressurized metered-dose inhaler (pMDI). Results were presented today at the International Conference of the American Thoracic Society held in Toronto, Canada, May 16-21, 2008.

Children with asthma, who are not adequately controlled by ICS treatment, may have their sleep affected by asthma symptoms,6 said Kathy Lampl, MD, Director, Clinical Research, AstraZeneca. Combination treatment with inhaled ICS and LABA is one of the recommended regimens for children who have moderate to severe persistent asthma or are not controlled with ICS treatment alone, as per the NIH Guidelines. 7.

AstraZeneca (NYSE:AZN) anticipates filing a supplemental new drug application with the Food and Drug Administration for the pediatric indication of SYMBICORT in the first half of 2008.........

Posted by: JoAnn      Read more         Source


May 18, 2008, 9:03 PM CT

Personalized therapy for asthma and COPD

Personalized therapy for asthma and COPD
Scientists at Washington University School of Medicine in St. Louis have defined a new type of immune response that is activated in patients with severe asthma and COPD (chronic obstructive pulmonary disease). Their discovery could dramatically improve diagnosis and therapy of patients with chronic inflammatory lung disease.

"We've cracked the first part of the molecular code that links a viral infection to the later development of chronic inflammatory diseases like asthma and COPD," says senior author Michael Holtzman, M.D., the Selma and Herman Seldin Professor of Medicine, director of the Division of Pulmonary and Critical Care Medicine and a pulmonary specialist at Barnes-Jewish Hospital. "With this information, we can more precisely diagnose and monitor these types of diseases and then better target our therapy to specific abnormalities. That's a big step forward from simply monitoring breathing status".

The findings, published online May 18, 2008, in Nature Medicine, promise a way to determine whether a patient's asthma or COPD is the result of a chronic immune response that can be turned on by a respiratory viral infection. Guided by these new findings, this type of immune response could be detected by monitoring specific types of inflammatory cells or molecules in the lung or potentially in the bloodstream, giving physicians a more precise approach to diagnosis and therapy of lung disease.........

Posted by: JoAnn      Read more         Source


May 3, 2008, 7:45 PM CT

1 in 10 children using cough, cold medications

1 in 10 children using cough, cold medications
Image courtesy of http://www.smh.com.au/
Scientists from Boston Universitys Slone Epidemiology Center have observed that approximately one in ten U.S. children uses one or more cough and cold medications during a given week. These findings will be presented today at the 2008 Pediatric Academic Societies & Asian Society for Pediatric Research Joint Meeting in Honolulu, Hawaii.

Pediatric cough and cold medications are widely marketed in the U.S. but surprisingly little is known about just how often they are used in children. This information is particularly important in light of recent revelations that cough and cold medications are responsible for serious adverse events and even deaths among children.

To define the frequency and patterns of use, the scientists analyzed data between 1999 and 2006 from the Slone Survey, a national telephone survey of medicine use in a representative sample of the U.S. population. The authors considered all oral medicines that are approved by the FDA to treat childrens coughs and colds.

The scientists observed that in a given week, at least one cough and cold medicine was used by 10.1 percent of U.S. children. In terms of active ingredients contained in these medications, exposure was highest to decongestants and antihistamines (6.3 percent each), followed by anti-cough ingredients (4.1 percent) and expectorants (1.5 percent).........

Posted by: JoAnn      Read more         Source


April 9, 2008, 10:12 PM CT

Traffic exhaust can cause asthma

Traffic exhaust can cause asthma
Children exposed to high levels of air pollution during their first year of life run a greater risk of developing asthma, pollen allergies, and impaired respiratory function. However, genetic factors are also at play. These are the results of a new study conducted under the BAMSE project.

The BAMSE project has monitored 4,000 children in Stockholm county from birth in order to assess whether exposure to traffic pollution during their first year of life affects the risk of developing asthma and allergies. Levels of traffic exhaust were measured at the site of the home. The results show that the children who were exposed to high concentrations of pollutants ran a 60 per cent higher risk of suffering of persistent asthma symptoms. Respiratory function was also adversely affected, and the children were much more likely to be allergic to airborne allergens, especially pollen.

Studies were also made of how the risk of developing air pollution-related allergies is influenced by genetic factors. It was observed that children carrying a variant of GSTP1 (glutathione S-transferase P1) gene, which is crucial to the bodys ability to take care of air pollutants (the antioxidative system), run a greater risk of developing an allergy associated with traffic-related air pollution. As per new analyses, variants of another asthma gene, TNF (tumour necrosis factor), also affect sensitivity to air pollution. Children with a particular combination of GSTP1 and TNF variants run a considerably higher risk of developing allergies.........

Posted by: JoAnn      Read more         Source


April 9, 2008, 8:45 PM CT

First do no harm?

First do no harm?
Richard Bond, associate professor of pharmacology at UH, pictured in his lab with tools he's used in research that takes a new approach to treating asthma by using a concept called "paradoxical pharmacology."

Credit: Thomas Shea
One month of tough breathing may help asthma sufferers breathe easier in the long run, as per research from one University of Houston professor.

In a move that challenges one of the most basic tenets of the Hippocratic Oath first do no harm Richard Bond, associate professor of pharmacology at UH, is relying on a long-standing medical taboo to treat asthma. Eventhough counterintuitive, Bonds studies are reminiscent of hair-of-the-dog folk wisdom to treat like with like, in this case using beta blockers (or antagonists) instead of stimulants (or agonists) in asthmatics.

Coining the term paradoxical pharmacology treating patients with medicine that initially worsens their symptoms before eventually improving their overall health Bond first applied this hypothesis in studies with mice and then moved on to two clinical trials with humans. Currently in the second clinical trial, the part of this research analyzing mice was recently reported in the American Journal of Respiratory Cell and Molecular Biology, which cited the relevance of Bonds work as possibly leading to a paradigm shift in the therapy of asthma. The results of the first human trial were also recently published in Pulmonary Pharmacology and Therapeutics.

Acute asthma attacks have traditionally been treated with inhaler-type stimulant drugs that open constricted airways. Giving beta blockers to asthmatics has long been believed to be contraindicated, because their acute use may cause increased airway resistance. While the use of beta-stimulants is known to provide temporary relief, their effectiveness declines over time.........

Posted by: JoAnn      Read more         Source


April 7, 2008, 10:45 PM CT

Asthma and Smoker's Lung

Asthma and Smoker's Lung
Dry airways may not only play a central role in the development of the in-herited lung disease cystic fibrosis, but also in much more common ac-quired chronic lung diseases such as asthma and smoker's lung, the ciga-rette smoke-induced chronic obstructive pulmonary disease (COPD). This is the conclusion reached by researchers at Heidelberg University Hospital under the direction of Assistant Professor Dr. Marcus Mall from the Department of Pediatrics at Heidelberg University Hospital and Professor Dr. Richard Boucher of the University of North Carolina at Chapel Hill. In ani-mal studies, they observed that insufficient hydration of the airway surfaces leads to pathologies typical of chronic obstructive lung diseases in humans.

Thus, these findings point to a new approach for the therapy of these diseases, which are listed by the World Health Organization WHO as the fourth leading cause of death worldwide. There are currently no causal therapies available for treating these diseases; only the symptoms such as shortness of breath and oxygen deficiency can be treated. The results of the study have now been reported in the "American Journal of Respira-tory and Critical Care Medicine".

Cystic fibrosis gene causes airways to dry out and thickens mucus.

In the hereditary disease cystic fibrosis, which affects about 8,000 people in Gera number of (about 80,000 people in the Western world), a defective gene causes a change in the transport of salt and water across the mucosal sur-faces in the lungs, the intestine and other organs, and thus produce a change in the composition of the secretions.........

Posted by: JoAnn      Read more         Source


March 9, 2008, 5:52 PM CT

Allergic Response Tied to Lipid Molecules

Allergic Response Tied to Lipid Molecules
A team of Penn State University scientists is the first to demonstrate that lipid molecules in cell membranes participate in mammals' reactions to allergens in a living cell. The finding will help researchers better understand how allergy symptoms are triggered, and could contribute to the creation of improved drugs to treat them. The work would be published in the 14 recent issue of the Journal of Biological Chemistry.

The team studied clusters of cholesterol-rich lipid molecules that they believe serve as platforms for the receptors that receive antibodies, the proteins that protect the body from allergens. In this case, the team examined IgE antibodies, which upon binding to their receptors initiate a cell's release of histamine--the substance that causes the unpleasant, but beneficial, mucous production, congestion, and itchiness linked to allergies. "This research is basically the molecular foundation for why a number of people sneeze in the spring," said Ahmed Heikal, an associate professor in the Department of Bioengineering and a leader of the project.

While the idea that lipid clusters--also known as lipid domains--are involved in the allergic response is not new, the Penn State team is the first to document this connection in a living cell under physiological conditions. "No one has observed the domains in action because they are too small and too transient--held together by very weak molecular interactions--to be viewed with a light microscope," said Erin Sheets, a Penn State assistant professor of chemistry who also is a leader of the project. "To overcome this challenge," added Heikal, "we used a combination of imaging and spectroscopy techniques that we are in the process of developing in our laboratories.........

Posted by: JoAnn      Read more         Source


March 2, 2008, 8:57 PM CT

Increased allergen levels in homes linked to asthma

Increased allergen levels in homes linked to asthma
Results from a new national survey demonstrate that elevated allergen levels in the home are linked to asthma symptoms in allergic individuals. The study suggests that asthmatics that have allergies may alleviate symptoms by reducing allergen exposures inside their homes. The work was carried out by scientists at the National Institute of Environmental Health Sciences (NIEHS), the University of Iowa, Rho Inc., and the Constella Group. The teams findings may help millions of Americans who suffer from asthma.

Indoor allergen exposures are of great importance in relation to asthma because most people spend a majority of their time indoors, particularly at home, said Darryl Zeldin, M.D., a Principal Investigator in the Laboratory of Respiratory Biology at NIEHS and senior author on the paper.

Asthma is one of the most common chronic ailments in the United States, affecting more than 22 million people. Asthma has been shown to be triggered by a wide range of substances called allergens.

The findings, published online and available in the recent issue of the Journal of Allergy & Clinical Immunology, show that exposure to multiple indoor allergens was common in U.S. households with 52 percent having at least six detectable allergens and 46 percent having three or more allergens at increased levels. The indoor allergens studied included those from dog, cat, mouse, cockroach, dust mite, and the fungus Alternaria.........

Posted by: JoAnn      Read more         Source



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Did you know?
Scientists at Yale have brought to light a mechanism that regulates the way an internal organelle, the Golgi apparatus, duplicates as cells prepare to divide, according to a report in Science Express.Graham Warren, professor of cell biology, and colleagues at Yale study Trypanosoma brucei, the parasite that causes Sleeping Sickness. Like a number of parasites, it is exceptionally streamlined and has only one of each internal organelle, making it ideal for studying processes of more complex organisms that have a number of copies in each cell.

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