Evidence map›Paper›PMID 42548501›Full record

ArticleCHEST pulmonary2025

Lung Function and Safety Outcomes in Patients With Moderate-to-Severe COPD Treated With Ensifentrine: A Pooled Analysis of the ENHANCE Trials.

Diego J Maselli, Jessica Bon, Tara Rheault, Amy Dixon, Daniel Reyner, Kathleen Rickard, Michael G Lester

2 registry-linked trialsAbstract read
In one paragraph

Article in CHEST pulmonary, 2025. 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. 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
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.

NCT04535986 phase3completednot on this map

A Phase III Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Ensifentrine Over 24 Weeks (With a 48-week Safety Subset) in Subjects With Moderate to Severe COPD

TypeinterventionalSponsorVerona Pharma, Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USARan2020 to 2022Enrolled763ConditionsChronic Obstructive Pulmonary DiseaseArmsEnsifentrine, Placebo
NCT04542057 phase3completednot on this map

A Phase III Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Ensifentrine Over 24 Weeks in Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease

TypeinterventionalSponsorVerona Pharma, Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USARan2020 to 2022Enrolled790ConditionsChronic Obstructive Pulmonary DiseaseArmsEnsifentrine, Placebo
3 · Its place in the literature

Who cites it

0 citing papers in PubMed.

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.

Diego J MaselliDivision of Pulmonary Diseases & Critical Care, University of Texas Health, South Texas Veterans Health Care System, San Antonio, TX.
Jessica BonDepartment of Pulmonary, Critical Care, Allergy, and Immunologic Diseases, Wake Forest University School of Medicine, Winston-Salem, NC.
Tara RheaultVerona Pharma plc, Raleigh, NC.
Amy DixonVerona Pharma plc, Raleigh, NC.
Daniel ReynerVerona Pharma plc, Raleigh, NC.
Kathleen RickardVerona Pharma plc, Raleigh, NC.
Michael G LesterDepartment of Pulmonary and Critical Care Medicine, Vanderbilt Medical Center, Nashville, TN.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Background: Despite the use of maintenance therapies, many patients with COPD continue to experience persistent symptoms and impaired lung function. Ensifentrine is a novel, first-in-class selective dual inhibitor of phosphodiesterase (PDE) 3 and PDE4 with demonstrated nonsteroidal antiinflammatory activity and bronchodilatory effects. Research Question: Does ensifentrine improve lung function among patients with COPD? Study Design and Methods: This prespecified, pooled analysis of the phase 3, multicenter, randomized, double-anonymized, placebo-controlled Ensifentrine as a Novel Inhaled Nebulized COPD Therapy (ENHANCE-1 [NCT04535986] and ENHANCE-2 [NCT04542057]) trials evaluated the effect of ensifentrine on lung function and safety outcomes. The trials included patients 40 to 80 years of age with symptomatic moderate-to-severe COPD who received 3 mg twice-daily ensifentrine or placebo for 24 weeks. Results: The pooled analysis included 975 patients treated with ensifentrine and 574 patients who received placebo. Ensifentrine significantly improved average FEV Interpretation: Ensifentrine demonstrated early, sustained, and clinically significant improvements in lung function in a broad population and across all subgroups of patients with symptomatic moderate-to-severe COPD.

Indexed as

COPDensifentrinelung functionphosphodiesterase inhibitorpooled analysissafety

Identifiers

PMID42548501
PMCPMC13419160

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.