Evidence map›Paper›PMID 25404569›Full record

Trial reportBMC pulmonary medicine2014

Efficacy and safety of aclidinium bromide/formoterol fumarate fixed-dose combinations compared with individual components and placebo in patients with COPD (ACLIFORM-COPD): a multicentre, randomised study.

Dave Singh, Paul W Jones, Eric D Bateman, Stephanie Korn, Cristina Serra, Eduard Molins, Cynthia Caracta, Esther Garcia Gil, Anne Leselbaum

Registry-linked trialOpen access · goldAbstract readClinical Trial, Phase IIIComparative StudyMulticenter Study
PubMed Full text at PMC Publisher
In one paragraph

Trial report in BMC pulmonary medicine, 2014. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01462942 (Efficacy and Safety of Aclidinium Bromide/Formoterol Fumarate Fixed-dose Combinations Compared With Individual Components and Placebo When Administered to Patients With Stable Chronic Obstructive Pulmonary Disease.), which is not on this map. Cited by 83 papers, 23 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
83citing papers in PubMed, 23 pooled it
21.5field-weighted citation impact, top 1% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT01462942 phase3completednot on this map

Efficacy and Safety of Aclidinium Bromide/Formoterol Fumarate Fixed-dose Combinations Compared With Individual Components and Placebo When Administered to Patients With Stable Chronic Obstructive Pulmonary Disease.

TypeinterventionalSponsorAstraZenecaRan2011 to 2013Enrolled2,443ConditionsChronic Obstructive Pulmonary Disease (COPD)ArmsAclidinium Bromide/Formoterol Fumarate, Aclidinium Bromide, Placebo, Formoterol Fumarate
3 · Its place in the literature

Who cites it

83 citing papers in PubMed, 23 syntheses or guidelines pooled it, 173 citations in OpenAlex.

  1. Race-Based Pulmonary Function Testing Correction in COPD Inhaler Therapy Trials: A Systematic Review.International journal of chronic obstructive pulmonary disease · 2024
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  17. Aclidinium bromide for stable chronic obstructive pulmonary disease.The Cochrane database of systematic reviews · 2014
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  18. LABA/LAMA fixed-dose combinations in patients with COPD: a systematic review.International journal of chronic obstructive pulmonary disease
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  20. LABA/LAMA fixed-dose combinationsTherapeutic advances in respiratory disease
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23 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

9 authors at 7 institutions in 7 countries.

Dave SinghUniversity of Manchester, Medicines Evaluation Unit, Langley Building, University Hospital of South Manchester NHS Foundation Trust, Southmoor Road, Manchester M23 9QZ, UK. dsingh@meu.org.uk.
Paul W Jones
Eric D Bateman
Stephanie Korn
Cristina Serra
Eduard Molins
Cynthia Caracta
Esther Garcia Gil
Anne Leselbaum
Almirall (Spain) · ESAstraZeneca (Spain) · ESAllergan (United States) · USInstitute of Infection and Immunity · CAJohannes Gutenberg University Mainz · DEUniversity of Cape Town · ZAUniversity of Manchester · GB

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundAclidinium/formoterol is a twice-daily (BID) fixed-dose combination (FDC) in development for chronic obstructive pulmonary disease (COPD). The efficacy and safety of aclidinium/formoterol versus monotherapy and placebo in patients with COPD was assessed.

methodsIn this 24-week double-blind, parallel-group, active- and placebo-controlled, multicentre Phase III study, patients (≥40 years, post-bronchodilator forced expiratory volume in 1 second [FEV1]/forced vital capacity <70% and FEV1 ≥30% but <80% predicted normal) were randomised 2:2:2:2:1 to aclidinium/formoterol 400/12 μg (n = 385) or 400/6 μg (n = 381), aclidinium 400 μg (n = 385), formoterol 12 μg (n = 384) or placebo (n = 194) BID via Genuair®/Pressair®a.

resultsAt Week 24, aclidinium/formoterol 400/12 μg and 400/6 μg lead to significant improvements from baseline in 1-hour post-dose FEV1 versus aclidinium (125 mL [95% CI: 90, 160; p < 0 · 001] and 69 mL [95% CI: 34, 105; p < 0.001], respectively) and trough FEV1 versus formoterol (85 mL [95% CI: 51, 119; p < 0.001] and 53 mL [95% CI: 19, 87; p < 0.01], respectively; co-primary endpoints). Additionally, aclidinium/formoterol 400/12 μg and 400/6 μg provided significant improvements in Transition Dyspnoea Index (TDI) focal score versus placebo (1.29 units [95% CI: 0.73, 1.86; p < 0.001] and 1.16 units [95% CI: 0.59, 1.73; p < 0.001], respectively; secondary endpoint). All treatments were well tolerated, with safety profiles of the FDCs similar to those of placebo and monotherapy.

conclusionsBoth aclidinium/formoterol BID doses significantly improved bronchodilation versus monotherapy, and dyspnoea versus placebo, with no increase in safety risk. Aclidinium/formoterol may be an effective treatment for patients with COPD.

trial registrationClinicalTrials.gov: NCT01462942.

Indexed as

AgedDouble-Blind MethodDrug CombinationsDyspneaFemaleForced Expiratory VolumeFormoterol FumarateHumansMaleMiddle AgedPulmonary Disease, Chronic ObstructiveQuality of LifeSeverity of Illness IndexTropanesVital Capacityaclidinium bromideDrug CombinationsFormoterol FumarateTropanes

Identifiers

PMID25404569
PMCPMC4273456
OpenAlexW2056040906

What OpenQuestion holds

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LicenceCC BY
Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.