Fluticasone propionate via the Diskhaler or hydrofluoroalkane-134a metered-dose inhaler on methacholine-induced airway hyperresponsiveness.

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Abstract

STUDY OBJECTIVE:s: To compare the effect of 4 weeks of treatment with fluticasone propionate (FP), 100 micro g bid, delivered either via the Diskhaler (GlaxoSmithKline; Middlesex, UK) or a hydrofluoroalkane (HFA)-134a pressurized metered-dose inhaler (pMDI) on airway responsiveness. DESIGN: A single-center, randomized, double-blind, double-dummy, placebo-controlled crossover study. SETTING: Outpatients. PATIENTS: Patients with mild asthma who had not received corticosteroids for 4 weeks prior to the study. INTERVENTIONS: FP, 100 micro g bid, via the Diskhaler, HFA-134a pMDI, or placebo for periods of 4 weeks. Measurements and results: The primary efficacy variable was the provocative dose of methacholine causing a 20% fall in FEV(1) (PD(20)) at the end of each 4-week treatment period. The FP formulations were defined as equivalent if the treatment difference was within +/- 1 doubling dose of methacholine. Forty-seven patients were included in the per-protocol population. The baseline PD(20) geometric mean was 0.21 mg, which increased to 0.55 mg with FP via the HFA-134a pMDI and to 0.68 mg with FP via the Diskhaler. The treatment difference between adjusted means was - 0.16 doubling doses (95% confidence interval, - 0.62 to 0.31 doubling doses; p = 0.503). Both significantly decreased airway responsiveness compared to placebo (p < 0.001), and also significantly increased lung function with no difference between the two active groups. FP was well tolerated with few adverse events and no effect on serum cortisol levels. CONCLUSIONS: FP delivered via the HFA-134a pMDI is equivalent to FP via the Diskhaler in reducing airway responsiveness.

Keyword(s)

Adult; Aerosol Propellants; Bronchial Provocation Tests; Comparative Study; Cross-Over Studies; Dose-Response Relationship, Drug; Double-Blind Method; Female; Human; Male; Middle Age; Nebulizers and Vaporizers; Support, Non-U.S. Gov't; Treatment Outcome; administration & dosage: Androstadienes; administration & dosage: Hydrocarbons, Fluorinated; blood: Hydrocortisone; diagnostic use: Methacholine Chloride; drug effects: Airway Resistance; drug effects: Forced Expiratory Volume; drug therapy: Bronchial Hyperreactivity

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