SAN DIEGO (November 6, 2002) -- An asthma treatment that contains both an inhaled long-acting bronchodilator and an inhaled corticosteroid was as effective at providing overall asthma control as more than double the dose of the inhaled corticosteroid alone, according to a study presented today at CHEST 2002, the annual scientific meeting of the American College of Chest Physicians.
This "inhaled corticosteroid-sparing" effect is an important consideration in asthma therapy. According to asthma treatment guidelines issued by the National Institutes of Health, inhaled corticosteroids are the most effective long-term-control medications available for the treatment of asthma.1 Though inhaled corticosteroids are generally well-tolerated at recommended doses, asthma treatment guidelines recommend that patients should use the lowest dose necessary for asthma control to help optimize the risk/benefit ratio for individual patients.1
The study compared Advair Diskus 100/50 -- which contains 100 mcg of fluticasone propionate (an inhaled corticosteroid) and 50 mcg of salmeterol (an inhaled long-acting bronchodilator) -- twice daily with fluticasone propionate 250 mcg twice daily. The study involved 558 patients 12 years of age and older who required fluticasone propionate 250 mcg twice daily for asthma control.
Advair Diskus is the first and only product to effectively treat the two main causes of asthma symptoms -- inflammation and bronchoconstriction -- in one easy-to-use2 device. Advair Diskus does not replace fast-acting inhalers to treat sudden symptoms.
In this study, Advair Diskus 100/50 twice daily was used to reduce the dose of inhaled corticosteroids by 60 percent while maintaining asthma control in patients requiring fluticasone propionate (FP) 250 mcg twice daily for asthma stability. This equivalence study also indicated that even though patients had stable asthma at randomization, there were numerical improvements in pulmonary function, percent of days with no asthma symptoms and need for supplemental albuterol in patients taking Advair Diskus 100/50 BID compared with patients taking FP 250 mcg BID. Confidence intervals for these clinical measures fell within the pre-defined margins of equivalence, demonstrating equivalence between treatment groups. Study results follow:
| Mean Change from Baseline (± SE) | Week 1 | Week 12 (endpoint) | ||
| Advair 100/50 (n=277) | FP 250 mcg (n=270) | Advair 100/50 (n=246) | FP 250 mcg (n=236) | |
| Withdrawal Due to worsening asthma | 1 % | 1% | 5% | 7% |
| FEV1 (L) | 0.07 (± 0.01)* | -0.02 (± 0.01) | 0.07 (± 0.01)* | -0.03 (± 0.01) |
| AM PEF (L/min) | 23.1 (± 1.9)* | 4.0 (± 1.8) | 36.6 (± 3.7)* | 18.4 (± 3.6) |
| Albuterol (puffs/day) | -0.35 (± 0.05)* | -0.18 (± 0.05) | -0.30 (± 0.07)* | -0.18 (± 0.06) |
| % Symptom-free days | 6.4 (± 1.6)* | 0.9 (± 1.4) | 11.7 (± 2.0)* | 5.8 (± 1.8) |
"Advair 100/50 BID allowed patients currently using higher doses of inhaled corticosteroids alone to reduce their dose of inhaled corticosteroids, as treatment guidelines recommend, while maintaining overall asthma control," said Steven A. Sahn, MD, professor of pulmonary and critical care medicine at the Medical University of South Carolina and one of the study's lead investigators. "The fact that Advair has both an inhaled corticosteroid and an inhaled long-acting bronchodilator in the same device made this a convenient treatment option as well."
The study was a randomized, double blind, double dummy, parallel group trial. Adolescent and adult patients, ages 12 and over, using medium doses of inhaled corticosteroids (FP 220 mcg BID or equivalent) had to complete two run-in periods prior to randomization. In the first run-in period, patients had to show clinical asthma instability on FP 100 mcg BID, followed by clinical stability on FP 250 mcg during the second run-in period. Thus, unlike other inhaled corticosteroid-sparing trials, the minimum effective dose of inhaled corticosteroids was established in all patients prior to randomization, and only patients who required FP 250 mcg BID for asthma stability were allowed to continue. Randomized patients had a mean baseline FEV1 (a measure of lung function) of 80-81 percent predicted and mean daily albuterol use (a measure of asthma control) of 0.82 puffs per day. All patients participated in the study for at least 12 weeks; and all patients (n=308) from a subset of study sites were randomized to treatment that continued for 24 weeks.
Overall, both of the treatments (Advair Diskus 100/50 BID and FP 250 mcg BID) were well tolerated. The incidence of common and pharmacologically predictable adverse events over the study period were similar for both treatments.
Advair Diskus is indicated for the long-term, twice-daily, maintenance treatment of asthma in patients 12 years of age and older. Advair is not indicated for the relief of acute bronchospasm, and does not replace fast-acting inhalers for the treatment of sudden symptoms. People switching from an oral steroid like prednisone to Advair, which contains an inhaled steroid, need to be especially careful. While adjusting to the switch, a person may not be as able to heal after surgery, infection or serious injury. Advair should be used with caution in patients with cardiovascular disorders. Some patients may experience increased blood pressure, heart rate or changes in heart rhythm. Patients should see their doctor if their asthma does not improve.
Contact Robin Gaitens at 919-483-2839 for complete prescribing information for Advair Diskus.
Sources
1. National Institutes of Health. National Heart, Lung, and Blood Institute. Highlights of the Expert Panel Report 2: Guidelines for the Diagnosis and Management of Asthma. NIH Publication No. 97-4051A.
2. Boulet LP, et al. Comparison of Diskus inhaler, a new multidose powder inhaler, with Diskhaler inhaler for the delivery of salmeterol to asthmatic patients. J Asthma 1995:32(6):429-436.