Biopsy Study Shows Long-Acting Beta2-Agonist And Low Steroid Dose In Advair Diskus(R) 100/50mcg Maintains Control Of Airway Inflammation

The largest biopsy study conducted to date demonstrates that a lower dose of an inhaled corticosteroid (ICS) with the addition of a long acting beta2-agonist (LABA) is as effective in maintaining control of airway inflammation as a medium-dose ICS alone in patients with moderate asthma. The study, published in the July issue of the Journal of Allergy and Clinical Immunology (JACI), compared Advair Diskus (fluticasone propionate and salmeterol) 100/50 mcg with fluticasone propionate (FP) 250 mcg over a 24-week treatment period in patients requiring a medium-dose ICS.

"It is important that physicians review the ICS dose used with their asthma patients on a regular basis, and reduce the dose to the minimum that will effectively control the disease," said lead study investigator Dr. Nizar N. Jarjour, Professor and Head Section of Allergy, Pulmonary and Critical Care, Department of Medicine at the University of Wisconsin in Madison. "These findings reinforce an earlier study which shows that adding a LABA to a lower dose ICS is an effective treatment option for maintaining control of asthma."

The study findings are consistent with current National Institute of Health (NIH) Guidelines for the Diagnosis and Management of Asthma recommendations on the use of an ICS and a LABA as the preferred therapy for patients with moderate to severe persistent asthma. While the anti- inflammatory effects of ICS are well-established, long-term use at high doses has been associated with some side effects. This study may provide physicians with new insight to help evaluate long-term treatment of patients with moderate persistent asthma.

About the Study

The randomized, double-blind, parallel-group study was conducted in 88 patients 18 years of age or older with asthma and was designed to evaluate whether clinical asthma control and airway inflammation could be maintained after switching therapy from medium-dose FP to a combination of low-dose FP and salmeterol.

During the trial screening phase, patients with stable symptoms on a medium dose of ICS (220 mcg of FP twice daily or equivalent) demonstrated deteriorating asthma control after being stepped-down to 100 mcg of FP twice daily. Treatment was then increased to 250 mcg of FP twice daily for four weeks, and patients had to re-establish asthma control (based upon pre-defined criteria) to be included in the treatment phase of the study.

Patients included in the trial were randomized to therapy with an ICS alone (FP 250 mcg) or an ICS plus a LABA (Advair 100/50 mcg) twice daily and evaluated for 24 weeks of treatment. Bronchial biopsies and bronchoalveolar lavage (BAL) were performed prior to randomization and after the 24 week treatment period. Clinical control of asthma and airway inflammation measures did not differ between the two treatment groups. Additionally the study provides direct evidence that reduction of an ICS when done in conjunction with the introduction of a LABA does not lead to worsening airway inflammation.

Both treatments were well-tolerated, and the incidence of common adverse events was similar in the two treatment groups. Reported adverse events related to the study occurred in 6 (15 percent) and 8 (17 percent) subjects treated with Advair 100/50 mcg and 250 mcg of FP, respectively. No adverse events occurred in more than one patient in each treatment group and included oral candidiasis, palpitation and headache. There were no serious drug- related adverse events during the treatment period.

Important Information About Advair Diskus

Advair Diskus is approved for the maintenance treatment of asthma in patients 4 years of age and older. Because LABAs may increase the risk of asthma-related death, Advair is for patients not adequately controlled on other asthma-controller medications (e.g., low- to medium-dose inhaled corticosteroids) or whose disease severity clearly warrants treatment with two maintenance therapies. Advair is not approved for patients whose asthma can be managed with an ICS along with occasional use of short-acting beta- agonists. Advair Diskus is not indicated for the relief of acute bronchospasm.

People should speak to their doctor about the risks and benefits of treating their asthma with Advair. People taking Advair should see their doctor if their asthma does not improve. People 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 is for patients 4 years and older. For patients 4 to 11 years old, Advair 100/50 is for those who have asthma symptoms while on an inhaled corticosteroid.

About Asthma

For many of the more than 20 million Americans with asthma, undertreatment of the disease can lead to frequent symptoms and attacks, activity limitation, and a decline in lung function. Research has established that the two main components of asthma are inflammation, or swelling inside the airways, and constriction, or tightening of the muscles that surround the airways. Both of these components play crucial roles in causing asthma symptoms such as shortness of breath, wheezing, chest tightness and cough. Optimal therapy for many patients with persistent moderate to severe asthma requires treatment of both of these components.

Each year, asthma causes nearly two million emergency room visits and more than 5,000 deaths. Additionally, nearly $16 billion in direct healthcare costs and indirect costs, such as lost workdays and productivity, are due to asthma.

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