Evidence map›Paper›PMID 25756831›Full record

Trial reportRespiratory research2014

Efficacy and safety of fixed-dose combinations of aclidinium bromide/formoterol fumarate: the 24-week, randomized, placebo-controlled AUGMENT COPD study.

Anthony D D'Urzo, Stephen I Rennard, Edward M Kerwin, Victor Mergel, Anne R Leselbaum, Cynthia F Caracta, AUGMENT COPD study investigators

Registry-linked trialOpen access · goldAbstract readClinical Trial, Phase IIIMulticenter StudyRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Respiratory research, 2014. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01437397 (A Phase III, Randomized, Double-blind, Placebo-Controlled Study Evaluating the Efficacy, Safety, and Tolerability of Two Fixed Dose Combinations of Aclidinium Bromide/Formoterol Fumarate Compared With Aclidinium Bromide, Formoterol Fumarate and Placebo for 24- Weeks Treatment in Patients With Moderate to Severe, Stable Chronic Obstructive Pulmonary Disease), which is not on this map. Cited by 72 papers, 19 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
72citing papers in PubMed, 19 pooled it
17.6field-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.

NCT01437397 phase3completednot on this map

A Phase III, Randomized, Double-blind, Placebo-Controlled Study Evaluating the Efficacy, Safety, and Tolerability of Two Fixed Dose Combinations of Aclidinium Bromide/Formoterol Fumarate Compared With Aclidinium Bromide, Formoterol Fumarate and Placebo for 24- Weeks Treatment in Patients With Moderate to Severe, Stable Chronic Obstructive Pulmonary Disease (COPD).

TypeinterventionalSponsorAstraZenecaRan2011 to 2013Enrolled1,692ConditionsChronic Obstructive Pulmonary DiseaseArmsAclidinium Bromide/Formoterol Fumarate, Aclidinium Bromide, Formoterol Fumarate, Placebo
3 · Its place in the literature

Who cites it

72 citing papers in PubMed, 19 syntheses or guidelines pooled it, 147 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. LABA/LAMA fixed-dose combinations in patients with COPD: a systematic review.International journal of chronic obstructive pulmonary disease
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12 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

7 authors at 4 institutions in 3 countries.

Anthony D D'Urzo
Stephen I Rennard
Edward M Kerwin
Victor Mergel
Anne R Leselbaum
Cynthia F Caracta
AUGMENT COPD study investigators
Almirall (Spain) · ESClinical Research Institute · USUniversity of Nebraska Medical Center · USUniversity of Toronto · CA

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundCombining two long-acting bronchodilators with complementary mechanisms of action may provide treatment benefits to patients with chronic obstructive pulmonary disease (COPD) that are greater than those derived from either treatment alone. The efficacy and safety of a fixed-dose combination (FDC) of aclidinium bromide, a long-acting muscarinic antagonist, and formoterol fumarate, a long-acting β2-agonist, in patients with moderate to severe COPD are presented.

methodsIn this 24-week double-blind study, 1692 patients with stable COPD were equally randomized to twice-daily treatment with FDC aclidinium 400 μg/formoterol 12 μg (ACL400/FOR12 FDC), FDC aclidinium 400 μg/formoterol 6 μg (ACL400/FOR6 FDC), aclidinium 400 μg, formoterol 12 μg, or placebo administered by a multidose dry powder inhaler (Genuair®/Pressair®)*. Coprimary endpoints were change from baseline to week 24 in 1-hour morning postdose FEV1 (FDCs versus aclidinium) and change from baseline to week 24 in morning predose (trough) FEV1 (FDCs versus formoterol). Secondary endpoints were change from baseline in St. George's Respiratory Questionnaire (SGRQ) total score and improvement in Transition Dyspnea Index (TDI) focal score at week 24. Safety and tolerability were also assessed.

resultsAt study end, improvements from baseline in 1-hour postdose FEV1 were significantly greater in patients treated with ACL400/FOR12 FDC or ACL400/FOR6 FDC compared with aclidinium (108 mL and 87 mL, respectively; p < 0.0001). Improvements in trough FEV1 were significantly greater in patients treated with ACL400/FOR12 FDC versus formoterol (45 mL; p = 0.0102), a numerical improvement of 26 mL in trough FEV1 over formoterol was observed with ACL400/FOR6 FDC. Significant improvements in both SGRQ total and TDI focal scores were observed in the ACL400/FOR12 FDC group at study end (p < 0.0001), with differences over placebo exceeding the minimal clinically important difference of ≥4 points and ≥1 unit, respectively. All treatments were well tolerated, with safety profiles of the FDCs similar to those of the monotherapies.

conclusionsTreatment with twice-daily aclidinium 400 μg/formoterol 12 μg FDC provided rapid and sustained bronchodilation that was greater than either monotherapy; clinically significant improvements in dyspnea and health status were evident compared with placebo. Aclidinium/formoterol FDC may be an effective and well tolerated new treatment option for patients with COPD.

trial registrationClinicaltrials.gov NCT01437397.

Indexed as

Administration, InhalationAdrenergic beta-2 Receptor AgonistsAgedAustraliaBronchodilator AgentsDouble-Blind MethodDrug Administration ScheduleDrug CombinationsDry Powder InhalersDyspneaFemaleForced Expiratory VolumeFormoterol FumarateHealth StatusHumansLungaclidinium bromideAdrenergic beta-2 Receptor AgonistsBronchodilator AgentsDrug CombinationsFormoterol FumarateMuscarinic AntagonistsTropanes

Identifiers

PMID25756831
PMCPMC4213545
OpenAlexW2030987445

What OpenQuestion holds

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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.