Evidence map›Paper›PMID 21518460›Full record

Trial reportRespiratory research2011

Efficacy and safety of once-daily aclidinium in chronic obstructive pulmonary disease.

Paul W Jones, Stephen I Rennard, Alvar Agusti, Pascal Chanez, Helgo Magnussen, Leonardo Fabbri, James F Donohue, Eric D Bateman, Nicholas J Gross, Rosa Lamarca and 2 more

2 registry-linked trialsAbstract readMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in Respiratory research, 2011. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Cited by 30 papers, 7 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
30citing papers in PubMed, 7 pooled it
–field-weighted citation impact
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.

NCT00358436 phase3completednot on this map

Efficacy and Safety of LAS 34273 in Patients With Moderate to Severe Stable Chronic Obstructive Pulmonary Disease(COPD)

TypeinterventionalSponsorAstraZenecaRan2006 to 2008Enrolled804ConditionsChronic Obstructive Pulmonary Disease (COPD)ArmsAclidinium bromide, Placebo
NCT00363896 phase3completednot on this map

Clinical Trial Assessing Efficacy and Safety of LAS34273 in Moderate to Severe Stable Chronic Obstructive Pulmonary Disease (COPD) Patients

TypeinterventionalSponsorAstraZenecaRan2006 to 2008Enrolled843ConditionsChronic Obstructive Pulmonary Disease (COPD)ArmsAclidinium bromide, Placebo
3 · Its place in the literature

Who cites it

30 citing papers in PubMed, 7 syntheses or guidelines pooled it.

  1. Efficacy and cardiovascular safety of LAMA in patients with COPD: a systematic review and meta-analysis.Journal of investigative medicine : the official publication of the American Federation for Clinical Research · 2021
    Pooled it
  2. Pooled it
  3. Pooled it
  4. Pooled it
  5. Aclidinium bromide for stable chronic obstructive pulmonary disease.The Cochrane database of systematic reviews · 2014
    Pooled it
  6. Pooled it
  7. Pooled it
  8. Revefenacin Area Under the Curve Spirometry in Patients with Moderate to Very Severe COPD.International journal of chronic obstructive pulmonary disease · 2024
    Trial
  9. Trial
  10. Trial
  11. Trial
  12. Article
  13. Patient-Reported Outcomes (PROs) in COPD Clinical Trials: Trends and Gaps.International journal of chronic obstructive pulmonary disease · 2020
    Review
  14. Review
  15. Article
  16. Review
  17. Relationship Between FEVChronic obstructive pulmonary diseases (Miami, Fla.) · 2016
    Article
  18. Review
  19. Positioning new pharmacotherapies for COPD.International journal of chronic obstructive pulmonary disease · 2015
    Review
  20. Clinical potential of aclidinium bromide in chronic obstructive pulmonary disease.International journal of chronic obstructive pulmonary disease · 2015
    Review
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

12 authors.

Paul W JonesSt George's, University of London, London, UK. pjones@sgul.ac.uk
Stephen I Rennard
Alvar Agusti
Pascal Chanez
Helgo Magnussen
Leonardo Fabbri
James F Donohue
Eric D Bateman
Nicholas J Gross
Rosa Lamarca
Cynthia Caracta
Esther Garcia Gil

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundThe long-term efficacy and safety of aclidinium bromide, a novel, long-acting muscarinic antagonist, were investigated in patients with moderate to severe chronic obstructive pulmonary disease (COPD).

methodsIn two double-blind, 52-week studies, ACCLAIM/COPD I (n=843) and II (n=804), patients were randomised to inhaled aclidinium 200 μg or placebo once-daily. Patients were required to have a post-bronchodilator forced expiratory volume in 1 second (FEV1)/forced vital capacity ratio of ≤70% and FEV1<80% of the predicted value. The primary endpoint was trough FEV1 at 12 and 28 weeks. Secondary endpoints were health status measured by St George's Respiratory Questionnaire (SGRQ) and time to first moderate or severe COPD exacerbation.

resultsAt 12 and 28 weeks, aclidinium improved trough FEV1 versus placebo in ACCLAIM/COPD I (by 61 and 67 mL; both p<0.001) and ACCLAIM/COPD II (by 63 and 59 mL; both p<0.001). More patients had a SGRQ improvement≥4 units at 52 weeks with aclidinium versus placebo in ACCLAIM/COPD I (48.1% versus 39.5%; p=0.025) and ACCLAIM/COPD II (39.0% versus 32.8%; p=0.074). The time to first exacerbation was significantly delayed by aclidinium in ACCLAIM/COPD II (hazard ratio [HR] 0.7; 95% confidence interval [CI] 0.55 to 0.92; p=0.01), but not ACCLAIM/COPD I (HR 1.0; 95% CI 0.72 to 1.33; p=0.9). Adverse events were minor in both studies.

conclusionAclidinium is effective and well tolerated in patients with moderate to severe COPD.

trial registrationClinicalTrials.gov: NCT00363896 (ACCLAIM/COPD I) and NCT00358436 (ACCLAIM/COPD II).

Indexed as

Administration, InhalationAgedBronchodilator AgentsDouble-Blind MethodDrug Administration ScheduleDry Powder InhalersDyspneaEuropeFemaleForced Expiratory VolumeHealth StatusHumansLogistic ModelsLungMaleMiddle Agedaclidinium bromideBronchodilator AgentsMuscarinic AntagonistsTropanes

Identifiers

PMID21518460
PMCPMC3098801

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.