First Inhaled Corticosteroid for Asthmatic Children Four Years and Older Available for Use

Easy-to-Monitor Flovent® Rotadisk® is Preventive Treatment for Asthma

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RESEARCH TRIANGLE PARK, N.C., April 21, 1998 -- Flovent® Rotadisk® (fluticasone propionate inhalation powder), the first and only inhaled corticosteroid medication indicated as a preventive therapy for asthma in children as young as four years of age, is now available by prescription in the U.S.

Representing the latest generation inhaled corticosteroid, Flovent Rotadisk is a highly effective, inhaled anti-inflammatory treatment for asthma, a chronic lung disease that is caused by inflammation of the airways and results in impaired breathing. According to the recently published National Institutes of Health (NIH) "Practical Guide for the Diagnosis and Management of Asthma," which advocates the early use of inhaled corticosteroids to control inflammation in the lungs, the daily use of inhaled corticosteroids may reduce the occurrence of asthma symptoms and severe exacerbations, and may help improve lung function.

"The availability of Flovent Rotadisk means that for the first time ever, physicians have an effective corticosteroid therapy for asthma patients as young as four years of age," said Dr. Edwin Bronsky, clinical professor of pediatrics, University of Utah, and director of the Intermountain Clinical Research Group in Salt Lake City.

"Another advantage with Flovent Rotadisk is that the medication is inhaled using a specially designed plastic device that is equipped with a dose counter," Bronsky said. "This allows parents to easily monitor their child's use of the medication."

Flovent Rotadisk is a foil-covered disk containing four blisters, or compartments, of powder medication. Once loaded into a specially designed plastic inhalation device called the Diskhaler®, a blister can be pierced and a dose of Flovent dispersed when the patient inhales through the mouthpiece of the Diskhaler. The disk is rotated after each piercing, revealing a new blister and providing parents with evidence of a child's use. The powder medication has a neutral or slightly sweet taste when inhaled.

Flovent Rotadisk, with twice-a-day-dosing, is the only inhaled powder corticosteroid asthma medication that can be tailored to each patient's condition with multiple dosing strengths. In addition to the 50 mcg and 100 mcg strengths, which are indicated for both children and adults, a 250 mcg strength is available for the treatment of asthma in adults. Flovent Rotadisk is not indicated for the relief of acute bronchospasm.

In doses ranging from 50 mcg to 500 mcg twice daily, Flovent Rotadisk was shown to be effective and well-tolerated in clinical trials involving 1197 adolescent and adult asthma patients and in 588 pediatric patients ages four to 11 years old, who received doses of 50 or 100 mcg twice daily. In a twelve-week clinical trial of 263 patients aged 4 to 11 years who were inadequately controlled on bronchodilators alone, Flovent Rotadisk, at doses of 50 or 100 mcg twice daily, significantly improved lung function (28% and 34% change from baseline, compared to placebo 11%).

In clinical trials, the most common side effects (greater than or equal to 5%) among patients at recommended doses of 50 mcg, 100 mcg, 250 mcg and 500 mcg were hoarseness (less than 1-6%), rhinitis (2-9%), sinusitis (4-6%), nasal congestion (4-7%), thrush (3-11%), sore throat (6-13%), headache (9-15%) and upper respiratory infection (16-22%). For adult patients being weaned from oral corticosteroids, particular care should be taken because adrenal insufficiency may occur when transferring to an inhaled corticosteroid. It is possible that systemic corticosteroid effects such as hypercorticism and adrenal suppression may appear in a small number of patients, particularly at higher doses. Patients should be titrated to the lowest effective dose.

Flovent Rotadisk is marketed by Glaxo Wellcome Inc., an industry leader in respiratory research. The company has a broad portfolio of both investigational and commercially available respiratory therapies.

CONTACT: Veronica Gontram of Glaxo Wellcome, 919-483-2839