A Phase II Study of Ensifentrine in Non-Cystic Fibrosis Bronchiectasis

Part of paid clinical trials in Birmingham, Alabama.

Sponsor
Verona Pharma, Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA
Study ID
NCT06559150
Phase
PHASE2
Status
Recruiting
Apply to this trial

Conditions

  • Non-cystic Fibrosis Bronchiectasis

Eligibility Criteria

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

Interventions

  • Nebulized Ensifentrine Suspension; 3 mg — DRUG
    Administered by a standard jet nebulizer, twice daily for a minimum of 24 weeks and up to a maximum of 52 weeks
  • Nebulized Placebo Solution — DRUG
    Administered by a standard jet nebulizer, twice daily for a minimum of 24 weeks and up to a maximum of 52 weeks

Study Details

This study is a randomized, double-blind, placebo-controlled study designed to assess the efficacy and safety of ensifentrine inhalation suspension (3 mg) delivered twice daily via standard jet nebulizer over at least 24 weeks, compared to placebo, in subjects with non-cystic fibrosis bronchiectasis (NCFBE).

Key Dates

Start date
Sep 11, 2024
Status verified
May 2026
Primary completion
Sep 24, 2027
Completion
Sep 24, 2027

Study Design

Enrollment
284 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Treatment Arm 1: Ensifentrine
  • Placebo Comparator: Treatment Arm 2: Placebo

Primary Outcome Measure

Rate of protocol-defined pulmonary exacerbations (number of events per subject-year) [ Time Frame: Through study completion (approximately 52 weeks) ]

Central Contacts

  • Verona Pharma, Inc., a subsidiary of Merck & Co., Inc. (Rahway Toll Free Number
    Reach out by phone or email
    [email protected]

Locations (29)

FacilityCityStateZIPSite coordinators
Kirklin Clinic of UAB HospitalBirminghamAlabama35233-
So Cal Institute for Respiratory Diseases, Inc.Los AngelesCalifornia90048-
University of California Davis Medical CenterSacramentoCalifornia95817-
National Jewish Health Main CampusDenverColorado80206-
MedStar Georgetown University HospitalWashington D.C.District of Columbia20007-
University of MiamiMiamiFlorida33136-
Emory University at Saint Joseph Pulmonary ClinicAtlantaGeorgia30342-
Augusta UniversityAugustaGeorgia30912-
ASHA Clinical ResearchHammondIndiana46324-
University of IowaIowa CityIowa52242-
University of Kansas Medical Center-Kansas CityKansas CityKansas66160-
Massachusetts General Hospital- 55 Fruit StBostonMassachusetts02114-
University of Michigan HospitalAnn ArborMichigan48109-
Mayo ClinicRochesterMinnesota55905-
Washington University School of MedicineSt LouisMissouri63110-
NYU Langone Health Pulmonary and Critical Care Associates, P.C. - BRANY - PPDSNew YorkNew York10016-
University of North CarolinaChapel HillNorth Carolina27514-
Accellacare of WilmingtonWilmingtonNorth Carolina28401-
Southeastern Research CenterWinston-SalemNorth Carolina27103-
Ohio State UniversityColumbusOhio43221-
Oregon Health and Science UniversityPortlandOregon97239-
Temple University HospitalPhiladelphiaPennsylvania19140-
Medical University of South Carolina (MUSC) - PPDSCharlestonSouth Carolina29425-
Velocity Clinical Research - Spartanburg - PPDSSpartanburgSouth Carolina29303-
Velocity Clinical Research - Union - PPDSUnionSouth Carolina29379-
Clinical Trials Center of Middle TennesseeFranklinTennessee37067-
The Respire InstituteHoustonTexas77094-
UT Texas Health Science at TylerTylerTexas75708-
TPMG Clinical ResearchWilliamsburgVirginia23188-

Find similar trials in Birmingham, AL

By research site
Kirklin Clinic of UAB Hospital· Birmingham, ALSo Cal Institute for Respiratory Diseases, Inc.· Los Angeles, CAUniversity of California Davis Medical Center· Sacramento, CANational Jewish Health Main Campus· Denver, COMedStar Georgetown University Hospital· Washington D.C., DCUniversity of Miami· Miami, FL

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