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Obstructive Lung Diseases |

Evaluation of the Efficacy and Safety of Two Doses of Aclidinium and Formoterol in Fixed-Dose Combination in Patients With COPD: The ACLIFORM Study FREE TO VIEW

Dave Singh, MD; Paul Jones, MD; Eric Bateman, MB; Stephanie Korn, MD; Cristina Serra; Eduard Molins; Cynthia Caracta, MD; Esther Garcia Gil, MD; Anne Leselbaum, MD
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Medicines Evaluation Unit, University Hospital of South Manchester, Manchester, United Kingdom


Chest. 2014;145(3_MeetingAbstracts):375A. doi:10.1378/chest.1796046
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Abstract

SESSION TITLE: COPD Posters

SESSION TYPE: Poster Presentations

PRESENTED ON: Saturday, March 22, 2014 at 01:15 PM - 02:15 PM

PURPOSE: Aclidinium bromide/formoterol fumarate fixed-dose combination (FDC) is being developed for treatment of COPD. This study assessed the efficacy and safety of two twice-daily (BID) FDCs vs monotherapies and placebo.

METHODS: This 24-week, double-blind study, randomized 1729 patients with stable COPD (mean±SD baseline FEV1 1.4±0.5 L; 54±13% predicted) to FDC 400/6 μg, FDC 400/12 μg, aclidinium 400 µg, formoterol 12 µg or placebo BID (2:2:2:2:1) via Genuair®/Pressaira. Co-primary endpoints were change from baseline in 1 h post-dose FEV1 (vs aclidinium) and trough FEV1 (vs formoterol). Treatment-emergent adverse events (TEAEs) were assessed.

RESULTS: Both FDC doses significantly improved 1 h post-dose FEV1: mean difference in change from baseline at Week 24 was 69 mL FDC 400/6 µg (p<0.001) and 125 mL FDC 400/12 µg (p<0.0001) vs aclidinium, and 244 ml FDC 400/6 µg, 299 ml FDC 400/12 µg, 174 mL aclidinium and 160 mL formoterol vs placebo (all p<0.0001; p<0.01 FDC 400/12 µg vs FDC 400/6 µg). At Week 24, mean difference in change from baseline in trough FEV1 was 53 mL FDC 400/6 µg (p<0.01) and 85 mL FDC 400/12 µg (p<0.0001) vs formoterol, and 111 ml FDC 400/6 µg, 143 ml FDC 400/12 µg, 117 mL aclidinium (all p<0.0001) and 58 mL formoterol (p<0.01) vs placebo. TEAE incidence was comparable across arms (49-57%). TEAEs most commonly associated with FDC (≥3% patients, FDC > placebo) were nasopharyngitis and back pain.

CONCLUSIONS: In COPD patients, FDC 400/12 µg provided greater bronchodilation than either monotherapy and was more effective than FDC 400/6 µg at 1 h post-dose. Both FDCs had safety profiles comparable to placebo.

CLINICAL IMPLICATIONS: Combining bronchodilators, with different modes of action, in FDC can provide patients with additional bronchodilation with no increase in safety risk. aRegistered trademarks of Almirall S.A., Barcelona, Spain, for use within the EU, Iceland and Norway as Genuair®, and within the USA as Pressair. This study was supported by Almirall S.A., Barcelona, Spain, and Forest Laboratories, Inc., New York, USA.

DISCLOSURE: Dave Singh: Grant monies (from industry related sources): AstraZeneca, GlaxoSmithKline, Chiesi, Boehringer Ingleheim, Roche, Novartis, Cipla, Almirall and Merck, Consultant fee, speaker bureau, advisory committee, etc.: AstraZeneca, GlaxoSmithKline, Chiesi, Boehringer Ingleheim, Roche, Novartis, Cipla, Almirall and Merck Paul Jones: Consultant fee, speaker bureau, advisory committee, etc.: Almirall S.A., Consultant fee, speaker bureau, advisory committee, etc.: Forest Laboratories, Inc. Eric Bateman: Consultant fee, speaker bureau, advisory committee, etc.: Almirall S.A., Consultant fee, speaker bureau, advisory committee, etc.: Forest Laboratories, Inc., Grant monies (from industry related sources): E D Bateman's has received payment from Almirall for participation in clinical trials Stephanie Korn: Consultant fee, speaker bureau, advisory committee, etc.: Almirall Cristina Serra: Employee: Almirall S.A. Eduard Molins: Employee: Almirall S.A. Cynthia Caracta: Employee: Almirall S.A. Esther Garcia Gil: Employee: Almirall S.A. Anne Leselbaum: Employee: Almirall S.A.

This abstracts presents the results of a double blind, randomized Phase III trial of a fixed combination of two products, each of which are approved as monotherapies for the treatment of COPD.


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