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Effect of Ensifentrine on Sputum Markers of Inflammation in COPD

StatusActive, Not Recruiting
PhasePhase 2
Started2022-05-27
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 2 months later Dec 2026 → Mar 1, 2027
See other at-risk trials from Merck (MSD)

Amendment history

2026-10-01
Enrollment closed, study ongoing
Primary completion pushed: 2026-12 → 2027-03-01
Completion moved earlier: 2027-06 → 2027-03-01
2026-05-10
Sponsor changed: Verona Pharma plc → Verona Pharma, Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA+61 characters
WasVerona Pharma plc
NowVerona Pharma, Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA
2026-05-08
Study Status, Contacts/Locations v6
Re-verified, no change to tracked fields
2026-02-11
Study Identification, Study Status, Oversight, Study Description, Study Design, Outcome Measures, Eligibility, Contacts/Locations v5
Enrollment target50→56
Study sites2→3
Eligibility criteria+46 characters
[...] ected QT interval by Fridericia's correction method >450 ms for males or >480 ms for females or history of significant cardiac dysrhythmia, including lon [...] aindications. Taking prohibited medication. Prior receipt of Ohtuvayre or blinded nebulized study medication in an ensifentrine (RPL5 [...]
Secondary endpoints7 to 13 entries
ChangeThe change from baseline in sputum neutrophilscell counts at Week 8 (absolute change in cell numbers). ChangeThe from baseline in other sputum PMN counts (eosinophils, basophils, macrophages, lymphocytes, total cells) at Week 8 (absolute change in cell numbers). Percentpercent change from baseline in sputum PMNcell counts (neutrophils, eosinophils, basophils, macrophages, lymphocytes and total cells) at Week 8. PercentThe percent change from baseline in sputum Proline-Glycine-Proline (PGP) at Week 8. Percent change from baseline in sputum cytokines, proteases, and other markers of inflam [...] [...]
Primary endpoints1 entry, revised
PercentThe change from baseline in sputum Acetylated Proline-Glycine-Proline (AcPGP)neutrophils at Week 8. (absolute change in cell numbers)
Study description-50 characters
[...] receive both ensifentrine and placebo during participation. No more than 50% former smokers will be enrolled. Participants will be randomized 1:1 to receive ensifentrine [...]
2025-02-27
Study Identification, Study Status, Oversight v4
Primary completion date2024-12→2026-12
Completion date2024-12→2027-06
Show 3 earlier versions
2024-07-17
Study Status, Contacts/Locations v3
Study sitesdetails revised at 1 of 2 sites
2024-04-05
Study Identification, Study Status, Study Description, Study Design, Eligibility, Contacts/Locations v2
Primary completion date2023-09-30→2024-12
Completion date2023-12-31→2024-12
Enrollment target40→50
Study sites1→2
Eligibility criteria+14 characters
[...] lator COPD therapy, in any form (e.g., LAMA, LABA, LAMA+LABA, LAMA+LABA+ICS), for at least 4 weeks prior to Screening and agrees to use [...] 19 test result indicating an active infection at Screening.*Note: Note: Patients with a positive COVID-19 antibody test from a past [...]
Study description-231 characters
This is a single center, randomized, double-blind, placebo-controlled, two-period cr [...] cipation. No more than 50% former smokers will be enrolled. Approximately 40 participantsParticipants will be randomized 1:1 to receive ensifentrine or placebo f [...] d 1 followed by the opposite treatment in Treatment Period 2 (20 to each treatment sequence completing both treatment periods): Treatment Period 1: Ensifentrine (n=20); Treatment Period 2: Placebo (n=20). Treatment Period 1: Placebo (n=20); Treatment Period 2: Ensifentrine (n=20). All participants will take study supplied albuterol (to us [...] daily COPD Mai [...]
2022-08-26
Not Yet Recruiting→Recruiting Study Status, Eligibility, Contacts/Locations v1
Trial statusNot Yet Recruiting→Recruiting
Start dateestimated 2022-04-01→confirmed 2022-05-27
2022-02-22
Original filing
Merck (MSD)
401 trials monitored
See 24 trials at risk
COPD
1,057 trials monitored
See 28 trials at risk
This is a randomized, double-blind, placebo-controlled, two-period cross-over study of nebulized ensifentrine (3 mg) or placebo administered BID for two 8-week Treatment Periods. All participants with receive both ensifentrine and placebo during participation. There are 7 in-clinic visits over a total duration of up to 24 weeks participation.
Trial Details
NCT Number NCT05270525
Lead Sponsor Verona Pharma, Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA
Collaborators: University of Alabama at Birmingham
Conditions COPD
Enrollment 56 participants
Start Date 2022-05-27
Primary Completion 2027-03-01 (estimated)
Study Completion 2027-03-01 (estimated)
Updated on ClinicalTrials.gov 2026-09-30