Long-term Efficacy and Safety of Fluticasone Propionate Powder Administered Once or Twice Daily via Inhaler to Patients With Moderate Asthma
| Autor: | Jeffery Adelglass, Patrick D. Wire, Richard ZuWallack, Dennis P. Clifford, Stuart M. Harding, Melissa A. Faris, Susan P. Duke |
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| Rok vydání: | 2000 |
| Předmět: |
Pulmonary and Respiratory Medicine
business.industry medicine.drug_class Inhaler Critical Care and Intensive Care Medicine medicine.disease Placebo Fluticasone propionate Dry-powder inhaler Anesthesia Medicine Corticosteroid Dosing Cardiology and Cardiovascular Medicine business Asthma medicine.drug Fluticasone |
| Zdroj: | Chest. 118:303-312 |
| ISSN: | 0012-3692 |
| Popis: | Objective To evaluate the efficacy and safety of fluticasone propionate administered as a once-daily or twice-daily regimen over a period of 1 year to patients with moderate asthma. Design Double-blind, randomized, parallel group, and placebo-controlled phase (12 weeks) and an open-label phase (54 weeks). Setting Multicenter study in an outpatient setting. Participants Patients (n = 253; age,≥ 12 years) with a mean FEV 1 of 67% predicted normal were stratified according to baseline therapy of maintenance inhaled corticosteroids vs β 2 -agonists alone. Measurements and interventions Fluticasone propionate (250μ g bid or 500 μg qd) or placebo (bid) was administered via the Diskus multidose powder inhaler (Glaxo Wellcome; Research Triangle Park, NC) for 12 weeks. During open-label treatment, patients were re-randomized to once-daily or twice-daily fluticasone propionate. Results Compared to placebo, fluticasone propionate administered qd or bid significantly improved FEV 1 (p 1 , albuterol use, and withdrawal due to lack of efficacy. During 54 weeks of open-label treatment, FEV 1 and PEF continued to improve with both regimens, and improvements seen in the first 12 weeks were maintained in patients who switched from twice-daily to once-daily dosing. Fluticasone propionate treatment over a 54-week period was well tolerated, with few drug-related adverse events, which were primarily topical effects of inhaled corticosteroids. Conclusions Fluticasone propionate powder improved lung function when administered either qd or bid over a 1-year period to patients with moderate asthma, with twice-daily dosing demonstrating significantly greater improvement in some efficacy parameters than once-daily dosing over the first 12 weeks of treatment. Fluticasone propionate treatment was not associated with significant systemic effects. |
| Databáze: | OpenAIRE |
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