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FDA Approves Fluticasone, Salmeterol Combination for Children

RESEARCH TRIANGLE PARK, N.C., April 22 /PRNewswire-FirstCall/ -- GlaxoSmithKline (NYSE:GSK) announced today that the U.S. Food and Drug Administration (FDA) approved the use of Advair 100/50 in children four years to eleven years of age with asthma who are symptomatic on inhaled corticosteroid therapy alone. Advair contains an inhaled corticosteroid (ICS) and a long-acting beta2-agonist (LABA) and is the only long-term preventative product that treats the two main components of asthma - airway inflammation and bronchoconstriction. According to the National Institutes of Health's treatment guidelines, an ICS in conjunction with a LABA is a preferred treatment for patients who still have symptoms while taking low dose ICS.

"Advair is a highly effective treatment for asthma, and it is great news that it is now available for children as young as four," said Joseph Spahn, M.D., Associate Professor of Pediatrics at National Jewish Medical Center and University of Colorado Health Sciences Center. "Not only will it help prevent asthma symptoms, but its twice daily dosing is convenient for both parents and children."

Asthma is a chronic lung disease with two main components: inflammation (airway-swelling and irritation) and bronchoconstriction (tightening of the muscles surrounding the airways). Both cause the airways to narrow, making it difficult to breathe. Asthma symptoms include wheezing, shortness of breath, chest tightness and difficulty breathing. FDA

"Treating inflammation and airway constriction is critical to controlling asthma symptoms," said Dr. Spahn. "An important advantage of Advair is that it combines two highly effective medicines in one device to treat these components."

Advair has been available in the US since April 2001 to treat asthma in patients 12 years of age and older and is the most commonly prescribed inhaled asthma maintenance therapy in the United States.

Asthma on the Rise
Asthma has been increasing in prevalence in the U.S. since 1980. A recent report issued by the U.S. Centers for Disease Control (CDC) indicates nine million children under the age of 18 have been diagnosed with asthma and 3.8 million of those children are between five and 11. Of these 3.8 million, 6.3% have had an asthma attack in the last year. Children with asthma miss more than 14 million school days every year, making asthma the number one cause of school absences due to chronic conditions.

Advair for Children 4 to 11 years of age with Asthma
The safety profile of Advair was studied in a 12-week trial conducted with 203 children, four to 11 years old with asthma, who were symptomatic on low doses of an inhaled corticosteroid. The primary objective of this study was to evaluate the safety of Advair 100/50 twice daily compared with fluticasone propionate (FP) 100mcg twice daily. The results showed that Advair had a similar safety profile to FP.

The study also included secondary efficacy measures of lung function as measured by FEV1 (forced expiratory volume in one second) in children six to 11. Patients receiving Advair and patients receiving FP experienced improved FEV1 over the course of the study.

The findings of this study, along with extrapolation of efficacy data from patients 12 years of age and older, support that Advair 100/50 is effective in the maintenance treatment of asthma in patients four to 11 years of age who are symptomatic on an inhaled corticosteroid.

Important Information About Advair
Advair is a long-term maintenance treatment for asthma in patients four and older. Advair won't replace fast-acting inhalers for sudden symptoms and should not be taken more than twice a day. Rare but serious asthma episodes and asthma-related fatalities occurred in a study with SEREVENT(R), one of the components of Advair. These risks may be greater in African Americans. While adjusting to a switch from an oral steroid, like prednisone, to the inhaled steroid in Advair, patients and doctors should be very careful, as patients may be less able to heal after surgery, infection, or serious injury. Patients should tell their doctor if they have a heart condition or high blood pressure. Some people may experience increased blood pressure, heart rate, or changes in heart rhythm. Advair contains an inhaled corticosteroid. Inhaled corticosteroids, as well as poorly controlled asthma, may cause a reduction in growth rate. The long term effect on final adult height is unknown. Patients should see their doctor if their asthma does not improve.

Source: GlaxoSmithKline

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