Evidence map›Paper›PMID 25539654›Full record

Trial reportBMC pulmonary medicine2014

Aclidinium improves exercise endurance, dyspnea, lung hyperinflation, and physical activity in patients with COPD: a randomized, placebo-controlled, crossover trial.

Kai M Beeh, Henrik Watz, Luis Puente-Maestu, Luis de Teresa, Diana Jarreta, Cynthia Caracta, Esther Garcia Gil, Helgo Magnussen

Registry-linked trialOpen access · goldAbstract readClinical Trial, Phase IIIRandomized Controlled Trial
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 NCT01471171 (A Multiple Dose, Randomised, Double-blind, Placebo Controlled, 2 Period Crossover Clinical Trial to Assess the Effect of Aclidinium Bromide 400 μg BID on Exercise Endurance in Patients With Stable Moderate to Severe Chronic Obstructive Pulmonary Disease), which is not on this map. Cited by 29 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
29citing papers in PubMed, 3 pooled it
8.0field-weighted citation impact, top 2% 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.

NCT01471171 phase3completednot on this map

A Multiple Dose, Randomised, Double-blind, Placebo Controlled, 2 Period Crossover Clinical Trial to Assess the Effect of Aclidinium Bromide 400 μg BID on Exercise Endurance in Patients With Stable Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD)

TypeinterventionalSponsorAstraZenecaRan2011 to 2012Enrolled112ConditionsChronic Obstructive Pulmonary Disease (COPD)ArmsAclidinium Bromide, Placebo
3 · Its place in the literature

Who cites it

29 citing papers in PubMed, 3 syntheses or guidelines pooled it, 71 citations in OpenAlex.

  1. Fixed-intensity exercise tests to measure exertional dyspnoea in chronic heart and lung populations: a systematic review.European respiratory review : an official journal of the European Respiratory Society · 2023
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  14. Effect of physical activity in lymphocytes senescence burden in patients with COPD.American journal of physiology. Lung cellular and molecular physiology · 2024
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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

8 authors at 5 institutions in 4 countries.

Kai M Beeh
Henrik Watz
Luis Puente-Maestu
Luis de Teresa
Diana Jarreta
Cynthia Caracta
Esther Garcia Gil
Helgo MagnussenPulmonary Research Institute at LungClinic Grosshansdorf, Airway Research Centre North, German Centre for Lung Research, Woehrendamm 80, D-22927 Grosshansdorf, Germany. magnussen@pulmoresearch.de.
AstraZeneca (Spain) · ESLungenClinic Grosshansdorf · DEAllergan (United States) · USHospital General Universitario Gregorio Marañón · ESRespiratory Research Institute · DE

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundThis study evaluated the effects of aclidinium bromide, a long-acting muscarinic antagonist indicated for maintenance treatment of chronic obstructive pulmonary disease (COPD), on exercise endurance, dyspnea, lung hyperinflation, and physical activity.

methodsIn this randomized, double-blind, crossover study, patients with stable COPD and moderate-to-severe airflow limitation received aclidinium 400 μg twice daily or placebo via Genuair®/Pressair(®a) for 3 weeks (2-week washout between treatment periods). The primary endpoint was change from baseline to Week 3 in endurance time, measured by constant work rate cycle ergometry testing at 75% peak incremental work rate. Changes from baseline in intensity of exertional dyspnea (Borg CR10 Scale®) and trough inspiratory capacity were secondary endpoints. Additional endpoints included changes from baseline in other spirometric, plethysmographic, and physical activity (assessed by objective accelerometer measurement) parameters. Efficacy endpoints were analyzed using an analysis of covariance model.

resultsIn total, 112 patients were randomized and treated (mean age 60.3 years; mean post-bronchodilator forced expiratory volume in 1 s 1.7 L [56.7% predicted]; mean endurance time 485.7 s). After 3 weeks, endurance time was significantly increased with aclidinium versus placebo (treatment difference 58.5 s; p < 0.05). At Week 3, aclidinium significantly reduced dyspnea intensity at isotime during exercise (treatment difference -0.63; p < 0.05) and improved trough inspiratory capacity (treatment difference 78 mL; p < 0.05) versus placebo. Significant improvements in spirometric, plethysmographic, and some physical activity parameters were observed with aclidinium versus placebo.

conclusionsThese results suggest that aclidinium significantly improves exercise endurance, exertional dyspnea, hyperinflation, and physical activity in patients with COPD.

trial registrationClinicalTrials.gov identifier: NCT01471171; URL: http://www.clinicaltrials.gov.

Indexed as

Exercise ToleranceMotor ActivityPhysical EnduranceAccelerometryAgedCross-Over StudiesDouble-Blind MethodDyspneaFemaleForced Expiratory VolumeHumansMaleMiddle AgedMuscarinic AntagonistsPulmonary Disease, Chronic ObstructiveTreatment Outcomeaclidinium bromideMuscarinic AntagonistsTropanes

Identifiers

PMID25539654
PMCPMC4364572
OpenAlexW1592776666

What OpenQuestion holds

Textmetadata
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.