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(Chest. 2002;122:806-811.)
© 2002 American College of Chest Physicians

Fluticasone Propionate via the Diskhaler or Hydrofluoroalkane-134a Metered-Dose Inhaler on Methacholine-Induced Airway Hyperresponsiveness*

Stephen J. Langley, MBChB; Janet Holden, RGN; Alison Derham, DCR (R) MPPM; Paul Hedgeland, LRSC AIMgt; Raj K. Sharma, PhD and Ashley Woodcock, MD

* From the Medicines Evaluation Unit (Dr. Langley, Mrs. Holden, and Mrs. Derham), Wythenshawe Hospital, Manchester; GlaxoSmithKline UK (Mr. Hedgeland and Dr. Sharma), Stockley Park, Uxbridge, Middlesex; and North West Lung Centre (Dr. Woodcock), Wythenshawe Hospital, Manchester, UK.

Correspondence to: Ashley Woodcock, MD, North West Lung Function Centre, Wythenshawe Hospital, Manchester, M23 9GP UK; e-mail: awoodcock{at}fs1.with.man.ac.uk

Study objectives: To compare the effect of 4 weeks of treatment with fluticasone propionate (FP), 100 µg 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 µg 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 FEV1 (PD20) 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 PD20 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.

Key Words: Diskhaler • fluticasone propionate • hydrofluoroalkane-134a • methacholine • placebo • provocative dose of methacholine causing a 20% fall in FEV1






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