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Once-daily single-inhaler versus twice-daily multiple-inhaler triple therapy in patients with COPD: lung function and health status results from two replicate randomized controlled trials.

ABSTRACT: BACKGROUND:The comparative efficacy of inhaled corticosteroid/long-acting muscarinic antagonist/long-acting ?2-agonist (ICS/LAMA/LABA) triple therapy administered via single or multiple inhalers in patients with chronic obstructive pulmonary disease (COPD) has not been evaluated comprehensively. We conducted two replicate trials comparing single- with multiple-inhaler ICS/LAMA/LABA combination in COPD. METHODS:207608 and 207609 were Phase IV, 12-week, randomized, double-blind, triple-dummy non-inferiority trials comparing once-daily fluticasone furoate/umeclidinium/vilanterol (FF/UMEC/VI) 100/62.5/25??g via Ellipta inhaler, with twice-daily budesonide/formoterol (BUD/FOR) 400/12??g via metered-dose inhaler plus once-daily tiotropium (TIO) 18??g via HandiHaler. Patients had symptomatic COPD and forced expiratory volume in 1?s (FEV1)

SUBMITTER: Ferguson GT 

PROVIDER: S-EPMC7257245 | biostudies-literature | 2020 May

REPOSITORIES: biostudies-literature

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Once-daily single-inhaler versus twice-daily multiple-inhaler triple therapy in patients with COPD: lung function and health status results from two replicate randomized controlled trials.

Ferguson Gary T GT   Brown Nicola N   Compton Chris C   Corbridge Thomas C TC   Dorais Kelly K   Fogarty Charles C   Harvey Catherine C   Kaisermann Morrys C MC   Lipson David A DA   Martin Neil N   Sciurba Frank F   Stiegler Marjorie M   Zhu Chang-Qing CQ   Bernstein David D  

Respiratory research 20200529 1

<h4>Background</h4>The comparative efficacy of inhaled corticosteroid/long-acting muscarinic antagonist/long-acting β<sub>2</sub>-agonist (ICS/LAMA/LABA) triple therapy administered via single or multiple inhalers in patients with chronic obstructive pulmonary disease (COPD) has not been evaluated comprehensively. We conducted two replicate trials comparing single- with multiple-inhaler ICS/LAMA/LABA combination in COPD.<h4>Methods</h4>207608 and 207609 were Phase IV, 12-week, randomized, double  ...[more]

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