Salmeterol/fluticasone propionate (50500 μg) in combination in a Diskus® inhaler (Seretide®) is effective and safe in the treatment of steroid-dependent asthma
| Autor: | W. R. Pieters, K.-O. Steinmetz, N. J. J. Schlösser, M. Aubier |
|---|---|
| Rok vydání: | 1999 |
| Předmět: |
Budesonide
Adult Male Pulmonary and Respiratory Medicine Adolescent medicine.drug_class Administration Topical Anti-Inflammatory Agents Peak Expiratory Flow Rate Fluticasone propionate Double-Blind Method Bronchodilator Forced Expiratory Volume Administration Inhalation medicine Humans Albuterol Anti-Asthmatic Agents Child Glucocorticoids Salmeterol Xinafoate Fluticasone Aged Fluticasone-Salmeterol Drug Combination business.industry Inhaler Nebulizers and Vaporizers Adrenergic beta-Agonists Middle Aged Asthma Bronchodilator Agents Androstadienes Drug Combinations Anesthesia Corticosteroid Drug Therapy Combination Female Salmeterol business medicine.drug |
| Zdroj: | Respiratory Medicine. 93(12):876-884 |
| ISSN: | 0954-6111 |
| DOI: | 10.1016/s0954-6111(99)90053-7 |
| Popis: | This multicentre double-blind, double-dummy study compared the safety and efficacy of a new combination Diskus inhaler containing both salmeterol 50 microg and fluticasone propionate 500 microg (Seretide, GlaxoWellcome, France) with the same doses of the two drugs delivered via separate Diskus inhalers and with the same dose of fluticasone propionate alone. Patients were eligible for study entry if they had received an inhaled corticosteroid continuously for 12 weeks prior to run-in, and had received treatment with beclomethasone dipropionate or budesonide 1500-2000 microg day(-1) or fluticasone propionate 750-1000 microg day(-1) for at least 4 weeks prior to run-in. In total, 503 patients receiving inhaled corticosteroids were randomized to 28 weeks' treatment with either salmeterol/fluticasone propionate (50/500 microg) via a single Diskus inhaler (combination) and placebo, or salmeterol 50 microg and fluticasone propionate 500 microg administered via separate Diskus inhalers (concurrent), or fluticasone propionate 500 microg and placebo. All treatments were administered twice daily, mean morning peak expiratory flow rate (PEFR) and asthma symptoms were measured for the first 12 weeks and safety data were collected throughout the 28-week study. Over weeks 1 to 12, improvement in adjusted mean morning PEFR was 35 and 33 l min(-1), respectively, in the combination and concurrent therapy treatment groups (12 and 10% increase from baseline, respectively). The mean difference between treatments was -3 l min(-1) (90% confidence interval -10.4 l min(-1)) which was within the criteria for clinical equivalence. However, the combination therapy was statistically significantly superior to fluticasone propionate alone for mean morning PEFR (P |
| Databáze: | OpenAIRE |
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