Evidence map›Paper›PMID 39854278›Full record

Trial reportChronic respiratory disease

Ensifentrine in COPD patients taking long-acting bronchodilators: A pooled post-hoc analysis of the ENHANCE-1/2 studies.

Mark Dransfield, Nathaniel Marchetti, Ravi Kalhan, Daniel Reyner, Amy L Dixon, Tara Rheault, Kathleen Ann Rickard, Antonio Anzueto

2 registry-linked trialsAbstract readClinical Trial, Phase IIIRandomized Controlled Trial
In one paragraph

Trial report in Chronic respiratory disease. 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 8 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
8citing papers in PubMed, 1 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.

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

8 citing papers in PubMed, 1 synthesis or guideline pooled it.

  1. Pooled it
  2. Trial
  3. Article
  4. Article
  5. Article
  6. Precision Medicine Advances in Chronic Lung Diseases.International journal of molecular sciences · 2025
    Article
  7. Review
  8. 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

8 authors.

Mark DransfieldMedicine/Pulmonary, Allergy and Critical Care, University of Alabama at Birmingham and the Birmingham VA Medical Center, Birmingham, AL, USA.
Nathaniel MarchettiThoracic Medicine and Surgery, Lewis Katz School of Medicine at Temple University, Philadelphia, PA, USA.
Ravi KalhanDivision of Pulmonary and Critical Care Medicine, Department of Preventive Medicine, Feinberg School of Medicine, Northwestern University, Chicago, IL, USA.
Daniel ReynerVerona Pharma plc, Raleigh, NC, USA.
Amy L DixonVerona Pharma plc, Raleigh, NC, USA.
Tara RheaultVerona Pharma plc, Raleigh, NC, USA.
Kathleen Ann RickardVerona Pharma plc, Raleigh, NC, USA.
Antonio AnzuetoSouth Texas Veterans Health Care System, University of Texas Health, San Antonio, TX, USA.ORCID 0000-0002-7007-588X

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundThe efficacy and safety of ensifentrine, a novel PDE3/PDE4 inhibitor, were previously evaluated in the ENHANCE-1 (NCT04535986) and ENHANCE-2 (NCT04542057) trials. Here, we present a pooled post-hoc subgroup analysis of patients according to background chronic obstructive pulmonary disease (COPD) maintenance medication regimens.

objectiveThis analysis aimed to explore the efficacy and safety of ensifentrine in patients receiving long-acting muscarinic antagonists (LAMA) or long-acting beta-agonists with inhaled corticosteroids (LABA + ICS).

methodsEligible patients had moderate to severe COPD, were aged 40-80 years, and were symptomatic at randomization. Patients were randomized 5:3, receiving twice-daily ensifentrine 3 mg or placebo via standard jet nebulizer over 24 weeks.

resultsThe pooled post-hoc analysis included 485 LAMA patients and 272 LABA + ICS patients. Ensifentrine showed lung function improvement over placebo at week 12, including average FEV

conclusionsNebulized ensifentrine offers a novel non-steroidal anti-inflammatory and bronchodilator treatment added to existing LAMA or LABA + ICS treatment options in patients with moderate to severe, symptomatic COPD.

Indexed as

Bronchodilator AgentsMuscarinic AntagonistsPulmonary Disease, Chronic ObstructiveAdministration, InhalationAdrenal Cortex HormonesAdrenergic beta-AgonistsAdultAgedAged, 80 and overDrug Therapy, CombinationFemaleForced Expiratory VolumeHumansIsoquinolinesMaleMiddle AgedAdrenal Cortex HormonesAdrenergic beta-AgonistsBronchodilator AgentsensifentrineIsoquinolinesMuscarinic AntagonistsPyrimidinonesChronic obstructive pulmonary diseasedual PDE3 and PDE4 inhibitorensifentrinemaintenance therapy

Identifiers

PMID39854278
PMCPMC11760128

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.