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Comparison of the effect of beclometasone/formoterol in asthma patients after methacholine‐induced bronchoconstriction: A noninferiority study using metered dose vs . dry powder inhaler
Author(s) -
Singh Dave,
Berg Frans,
Leaker Brian,
Corradi Massimo,
Jabbal Sunny,
Collarini Sara,
Mongelli Valentina,
Santoro Luigi,
Piccinno Annalisa,
Biondaro Sonia,
Lipworth Brian
Publication year - 2019
Publication title -
british journal of clinical pharmacology
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.216
H-Index - 146
eISSN - 1365-2125
pISSN - 0306-5251
DOI - 10.1111/bcp.13847
Subject(s) - medicine , dry powder inhaler , bronchoconstriction , beclometasone dipropionate , placebo , asthma , anesthesia , methacholine , inhaler , inhalation , formoterol , metered dose inhaler , lung , respiratory disease , budesonide , alternative medicine , pathology
Aims To demonstrate the noninferiority of extrafine beclomethasone/formoterol fumarate (BDP/FF) dry powder inhaler (DPI) vs . extrafine BDP/FF pressurized metered dose inhaler (pMDI; Foster® 100/6 μg NEXThaler and pMDI, respectively) in the onset of reliever effect after methacholine induced bronchospasm in asthmatic patients, evaluated in terms of forced expiratory volume in 1 s (FEV 1 ) at 5 min postdose. The DPI provides an alternative device option for patients who cannot use a pMDI properly during an acute asthma attack. Methods Sixty‐five patients received one inhalation of BDP/FF DPI, BDP/FF pMDI or placebo after methacholine challenge, according to a double‐blind, double‐dummy, cross‐over design. Lung function and Borg dyspnoea score were assessed up to 30 min postdose. Results FEV 1 adjusted mean difference between BDP/FF DPI and BDP/FF pMDI at 5 min postdose was 2 ml (95% confidence interval: –0.060; 0.065). A similar result was observed at the other time points. Median time to 85% recovery in FEV 1 was 8 min for BDP/FF DPI, 7.5 min for BDP/FF pMDI and 28 min for placebo ( P = 0.554 DPI vs . pMDI). The Borg score improved after treatment with both BDP/FF DPI and pMDI and the effect was greater than after placebo. Median time to reach 50% recovery was 4.2 min for BDP/FF DPI, 4.0 min for BDP/FF pMDI and 10.0 min for placebo ( P = 0.609 DPI vs . pMDI). Conclusions Extrafine Foster® NEXThaler, a flow‐independent DPI, is comparable to extrafine Foster® pMDI when administered as reliever therapy after methacholine challenge, thus supporting the maintenance and reliever therapy approach also with Foster® NEXThaler.