Comparison of bronchoprotective and bronchodilator effects of a single dose of formoterol delivered by hydrofluoroalkane and chlorofluorocarbon aerosols and dry powder in a double blind, placebo-controlled, crossover study

British Journal of Clinical Pharmacology
C M HoughtonA A Woodcock

Abstract

In response to the phasing out of chlorofluorocarbon (CFC) inhalers, a metered dose hydrofluoroalkane (HFA) formulation, Modulite (Chiesi Farmaceutici S.p.A, Parma, Italy), to be delivered with a pressurized metered dose inhaler (pMDI), has been developed. Modulite is a HFA formulation technology that has been designed to provide stable and uniform dose delivery of HFA-based formulations to enable an easy transition from CFC to HFA inhalers. The aim of this study was to compare the bronchoprotective and bronchodilator effects of a single dose of 12 microg of formoterol from the HFA Modulite inhaler with the Foradil Aerolizer (dry powder inhaler, DPI) and the Foradil CFC inhalers (Novartis Health Consumer, Basel, Switzerland). This was a double blind, double dummy, randomized, placebo-controlled, crossover study conducted in 38 subjects with mild to moderate asthma (mean forced expiratory volume in 1 s [FEV1] 87.5% predicted). The primary endpoint was methacholine challenge provocative dose required for 20% fall in the FEV1 (PD20) 90 min post dose. Bronchodilation was assessed with spirometry (FEV1, FVC, FEF25-75) and impulse oscillometry (resistance at 5 and 20 Hz, reactance at 5 Hz and resonant frequency) over the 90 min post ...Continue Reading

Associated Clinical Trials

References

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Citations

Jul 3, 2007·Annals of Allergy, Asthma & Immunology : Official Publication of the American College of Allergy, Asthma, & Immunology·Jung-Won ParkChein-Soo Hong
Jun 22, 2011·Journal of Aerosol Medicine and Pulmonary Drug Delivery·Vito BrusascoEmanuele Crimi
Mar 29, 2013·Annals of Allergy, Asthma & Immunology : Official Publication of the American College of Allergy, Asthma, & Immunology·Brian Lipworth
Aug 8, 2006·Pulmonary Pharmacology & Therapeutics·D AcerbiI Kottakis
Jun 6, 2014·The Lancet. Respiratory Medicine·Brian LipworthWilliam Anderson
Mar 21, 2015·Statistical Methods in Medical Research·Huang Li-ChingKwong Koon Shing
Jul 13, 2007·Contemporary Clinical Trials·Christopher J MillerWilliam S Mezzanotte
Apr 20, 2012·The Cochrane Database of Systematic Reviews·Christopher J Cates, Matthew J Cates
Feb 1, 2008·Expert Review of Respiratory Medicine·Jean Bousquet, Carmen Dell'anna
May 18, 2012·The Cochrane Database of Systematic Reviews·Bhupendrasinh F Chauhan, Francine M Ducharme
Jan 25, 2014·The Cochrane Database of Systematic Reviews·Bhupendrasinh F Chauhan, Francine M Ducharme
Mar 16, 2017·Clinical Pharmacokinetics·Omar S UsmaniEric Derom

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