NDLI: Onset of action of formoterol versus salmeterol via dry powder inhalers in moderate chronic obstructive pulmonary disease: a randomized, placebo-controlled, double-blind, crossover study.

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Onset of action of formoterol versus salmeterol via dry powder inhalers in moderate chronic obstructive pulmonary disease: a randomized, placebo-controlled, double-blind, crossover study.

Content Provider	World Health Organization (WHO)-Global Index Medicus
Author	Cazzola, Mario Paggiaro, Pierluigi Palange, Paolo Bjermer, Leif Ausin, Pilar Carlsson, Lars-Goran Ekelund, Jan Lotvall, Jan
Description	Country affiliation: Italy Author Affiliation: Cazzola M ( Unit of Respiratory Clinical Pharmacology, Department of Internal Medicine, University of Rome Tor Vergata, Rome, Italy. Mario.cazzola@uniroma2.it)
Abstract	BACKGROUND: Bronchodilator therapy is central to the symptomatic management of chronic obstructive pulmonary disease (COPD), and treatment with short-acting bronchodilators is recommended in patients with mild COPD. OBJECTIVE: This study aimed to evaluate the onset of effect of single-dose formoterol 9 µg versus single-dose salmeterol 50 µg in patients with moderate COPD. METHODS: In this multicentre, double-blind, double-dummy, placebo-controlled, three-way single-dose crossover study, patients ≥40 years of age with moderate COPD were randomized to single-dose formoterol 9 µg via Turbuhaler® plus placebo via Diskus®, single-dose salmeterol 50 µg via Diskus® plus placebo via Turbuhaler® or placebo via Turbuhaler® and Diskus® (washout period 2-7 days). Terbutaline 0.5 mg/actuation via Turbuhaler® was used as reliever medication throughout. The primary endpoint was forced expiratory volume in 1 second (FEV1) at 5 minutes post-dose. Secondary endpoints included proportion of patients achieving ≥12% increase in FEV1 at 5 minutes post-dose. RESULTS: 109 patients were randomized, and 108 completed the study. The increase in FEV1 5 minutes post-dose versus pre-dose was 7.2% for formoterol, 4.1% for salmeterol and 0.7% for placebo, and significantly greater for formoterol versus salmeterol (ratio of treatment effects: 1.030; 95% CI 1.008, 1.052; p = 0.009), for formoterol versus placebo (1.064, 95% CI 1.041, 1.087; p < 0.001) and for salmeterol versus placebo (1.033, 95% CI 1.011, 1.056; p = 0.003). The proportions of patients with ≥12% increase in FEV1 5 minutes post-dose were 23.1%, 9.2% and 6.4% for formoterol, salmeterol and placebo, respectively; this was statistically significantly larger after formoterol than salmeterol (p = 0.008) or placebo (p < 0.001). All treatments were well tolerated. CONCLUSION: In COPD patients, formoterol 9 µg has an onset of bronchodilatory effect that is more rapid than salmeterol 50 µg based on FEV1 at 5 minutes post-dose. CLINICAL TRIAL REGISTRATION: Clinicaltrials.gov identifier: NCT01048333; AstraZeneca study code: D5127C00001.
File Format	HTM / HTML
ISSN	11732563
Issue Number	3
Volume Number	32
e-ISSN	11791918
Journal	Clinical Drug Investigation
Language	English
Publisher	Springer
Publisher Date	2012-03-01
Publisher Place	New Zealand (Aotearoa)
Access Restriction	One Nation One Subscription (ONOS)
Subject Keyword	Discipline Pharmacology Albuterol Analogs & Derivatives Bronchodilator Agents Administration & Dosage Ethanolamines Pulmonary Disease, Chronic Obstructive Drug Therapy Adult Aged Aged, 80 And Over Cross-over Studies Double-blind Method Dry Powder Inhalers Female Forced Expiratory Volume Formoterol Fumarate Humans Male Middle Aged Physiopathology Salmeterol Xinafoate Comparative Study Journal Article Multicenter Study Randomized Controlled Trial Research Support, Non-u.s. Gov't
Content Type	Text
Resource Type	Article
Subject	Pharmacology (medical)

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