Onset of Bronchodilation with Fluticasone-Formoterol Combination Versus Fluticasone-Salmeterol in an Open-Label, Randomized StudyReport as inadecuate




Onset of Bronchodilation with Fluticasone-Formoterol Combination Versus Fluticasone-Salmeterol in an Open-Label, Randomized Study - Download this document for free, or read online. Document in PDF available to download.

Advances in Therapy

, Volume 29, Issue 11, pp 958–969

First Online: 17 October 2012Received: 28 June 2012

Abstract

IntroductionThe inhaled corticosteroid, fluticasone propionate fluticasone, and the long-acting beta2-agonist, formoterol fumarate formoterol, have been combined in a single aerosol inhaler fluticasone-formoterol. In a randomized, open-label study, fluticasone-formoterol showed similar efficacy to fluticasone-salmeterol after 12 weeks of treatment. This post-hoc analysis compared the onset of bronchodilation with the two treatments.

MethodsAdults with mild-to-moderate-severe persistent asthma were randomized to fluticasone-formoterol 100-10 or 250-10 μg twice daily b.i.d. or fluticasone-salmeterol 100-50 or 250-50 μg b.i.d. for 12 weeks. The onset of bronchodilation the first post-dose time point at which the forced expiratory volume in 1 second FEV1 was ≥12% greater than the pre-dose value, responder rates the proportion of patients achieving bronchodilation, and changes in FEV1 were assessed at days 0 baseline and 84.

ResultsFluticasone-formoterol n = 101 provided more rapid onset of bronchodilation than fluticasone-salmeterol n = 101 over the first 120 min post-dose on days 0 hazard ratio HR = 1.47 95% CI 1.05–2.05 and 84 HR = 1.77 95% CI 1.14–2.73. The odds of a patient achieving bronchodilation within 5 min of dosing were almost four-times higher with fluticasone-formoterol than with fluticasone-salmeterol on day 0 odds ratio OR = 3.97 95% CI 1.96–8.03 and almost 10-times higher on day 84 OR = 9.58 95% CI 2.14–42.90; the odds of achieving bronchodilation within 120 min post-dose were approximately twofold higher with fluticasone-formoterol on both days. The overall percentage increase in least-squares LS mean FEV1 during the 120-min post-dose period was significantly greater with fluticasone-formoterol than fluticasone-salmeterol on days 0 LS mean treatment difference: 4.70% 95% CI 1.57–7.83; P = 0.003 and 84 2.79% 95% CI 0.65–4.93; P = 0.011.

ConclusionThese analyses showed that fluticasone-formoterol provided a faster onset of bronchodilation than fluticasone-salmeterol, which was maintained over 12 weeks of treatment. This benefit may facilitate treatment adherence among patients with asthma.

KeywordsAsthma Bronchodilation Combination therapy Fluticasone Forced expiratory volume Formoterol Inhaled corticosteroid Long-acting beta2-agonist Respiratory To view enhanced content go to www.advancesintherapy.com

This article is published with open access at Springerlink.com

ClinicalTrials.gov identifier: NCT00476073

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Author: René Aalbers - Guy Brusselle - Tammy McIver - Birgit Grothe - Anna Bodzenta-Lukaszyk

Source: https://link.springer.com/







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