Evidence map›Paper›PMID 34528220›Full record

Trial reportAdvances in therapy2021

Efficacy of Aclidinium Bromide According to Baseline Therapy: Post-Hoc Analysis of ASCENT-COPD Randomized Trial.

Robert A Wise, Benjamin M Scirica, Deepak L Bhatt, Sami Z Daoud, Ferran Chuecos, Esther Garcia Gil, Kenneth R Chapman

Registry-linked trialOpen access · hybridAbstract readClinical Trial, Phase IVMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in Advances in therapy, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01966107 (Double-blind, Randomized, Placebo-controlled, Parallel-group, Phase IV Study to Evaluate the Effect of Aclidinium Bromide on Long-term Cardiovascular Safety and COPD Exacerbations in Patients With Moderate to Very Severe COPD), which is not on this map. Not yet cited in PubMed.

0numbers the graph read from it
0cells of the map it votes in
0citing papers in PubMed
–field-weighted citation impact, top 82% 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.

NCT01966107 phase4completednot on this map

Double-blind, Randomized, Placebo-controlled, Parallel-group, Phase IV Study to Evaluate the Effect of Aclidinium Bromide on Long-term Cardiovascular Safety and COPD Exacerbations in Patients With Moderate to Very Severe COPD (ASCENT COPD)

TypeinterventionalSponsorAstraZenecaRan2013 to 2017Enrolled3,635ConditionsCOPD, Chronic Obstructive Pulmonary Disease, Moderate to Very Severe COPDArmsAclidinium Bromide, Placebo
3 · Its place in the literature

Who cites it

0 citing papers in PubMed, 0 citations in OpenAlex.

No citing paper in PubMed yet.

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 5 institutions in 3 countries.

Robert A WisePulmonary and Critical Care, Johns Hopkins University School of Medicine, 5501 Hopkins Bayview Circle, Baltimore, MD, 21224, USA. rwise@jhmi.edu.ORCID http://orcid.org/0000-0002-8353-2349
Benjamin M SciricaBrigham and Women's Hospital, Boston, MA, USA.
Deepak L BhattBrigham and Women's Hospital, Boston, MA, USA.
Sami Z DaoudLate-Stage Respiratory and Immunology, BioPharmaceuticals R&D, AstraZeneca, Gaithersburg, MD, USA.
Ferran ChuecosLate-Stage Development, Respiratory and Immunology-Biometrics, BioPharmaceuticals R&D, AstraZeneca, Barcelona, Spain.
Esther Garcia GilRespiratory and Immunology, BioPharmaceuticals Medical, AstraZeneca, Barcelona, Spain.
Kenneth R ChapmanUniversity of Toronto, Toronto, ON, Canada.
AstraZeneca (Spain) · ESBrigham and Women's Hospital · USAstraZeneca (United States) · USJohns Hopkins University · USUniversity of Toronto · CA

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionLong-acting muscarinic antagonists (LAMAs), long-acting β

methodsASCENT-COPD was a phase 4, multicenter, double-blind, randomized, placebo-controlled, parallel-group study of patients with moderate-to-very severe COPD and increased cardiovascular risk. Patients were randomized 1:1 to receive aclidinium 400 μg or placebo twice daily, via a multidose dry-powder inhaler for up to 3 years. Outcomes included time to first major adverse cardiovascular events (MACE), all-cause mortality, change from baseline in trough forced expiratory volume in 1 s (FEV

resultsA total of 3589 patients were included (LABA, n = 227; ICS, n = 290; LABA + ICS, n = 2058; no maintenance, n = 1130). Aclidinium did not increase the risk of MACE or all-cause mortality versus placebo, regardless of baseline maintenance treatment. Reductions in moderate-to-severe exacerbation rates were observed with aclidinium versus placebo in all subgroups [LABA 43% (P = 0.046); ICS 25% (P = 0.202); LABA + ICS 22% (P = 0.003); no maintenance 18% (P = 0.130)]. Aclidinium improved morning trough FEV

conclusionIn patients with moderate-to-severe COPD and CV risk factors, the addition of aclidinium to maintenance therapy with LABA or LABA + ICS provided further benefit.

trial registrationClinicalTrials.gov identifier NCT01966107.

Indexed as

Adrenergic beta-2 Receptor AgonistsPulmonary Disease, Chronic ObstructiveAdministration, InhalationBronchodilator AgentsForced Expiratory VolumeHumansMuscarinic AntagonistsTropanesaclidinium bromideAdrenergic beta-2 Receptor AgonistsBronchodilator AgentsMuscarinic AntagonistsTropanesAclidinium bromideChronic obstructive pulmonary diseaseMuscarinic antagonists

Identifiers

PMID34528220
PMCPMC8478777
OpenAlexW3200209831

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
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.