Effect of Ensifentrine on Sputum Markers of Inflammation in COPD

Part of paid clinical trials in Birmingham, Alabama.

Sponsor
Verona Pharma, Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA
Study ID
NCT05270525
Phase
PHASE2
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
40 Years - 80 Years
Healthy Volunteers
Not accepted

Interventions

  • Ensifentrine — DRUG
    Ensifentrine twice daily administered with jet nebulizer for 8 weeks
  • Placebo — DRUG
    Placebo ensifentrine twice daily administered with jet nebulizer for 8 weeks

Study Details

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.

Key Dates

Start date
May 27, 2022
Status verified
May 2026
Primary completion
Dec 31, 2026
Completion
Jun 30, 2027

Study Design

Enrollment
56 participants (estimated)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT

Arms

  • Experimental: Treatment Sequence 1
    Treatment Period 1 (blinded Ensifentrine) followed by Treatment Period 2 (blinded Placebo)
  • Experimental: Treatment Sequence 2
    Treatment Period 1 (blinded Placebo) followed by Treatment Period 2 (blinded Ensifentrine)

Primary Outcome Measure

The change from baseline in sputum neutrophils at Week 8 (absolute change in cell numbers) [ Time Frame: Week 8 ]

Central Contacts

Locations (3)

FacilityCityStateZIPSite coordinators
University of Alabama at BirminghamBirminghamAlabama35205
Bennett Suttles
[email protected]
205-934-5555
James M Wells, MD (PRINCIPAL_INVESTIGATOR)
University of MichiganAnn ArborMichigan48109
G. Bautista
[email protected]
734.764.8146
Wassim Labaki, MD (PRINCIPAL_INVESTIGATOR)
University of Pittsburgh Medical CenterPittsburghPennsylvania15213
Paula Consolaro
[email protected]
412-648-6404
Frank C Sciurba, MD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Birmingham, AL

By condition
COPD
By specialty
PulmonologyLung disease
By research site
University of Alabama at Birmingham· Birmingham, ALUniversity of Michigan· Ann Arbor, MIUniversity of Pittsburgh Medical Center· Pittsburgh, PA

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