A Phase 3 Trial to Evaluate the Safety and Efficacy of Ensifentrine in Patients With COPD

Part of paid clinical trials in Alabaster, Alabama.

Sponsor
Verona Pharma, Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA
Study ID
NCT04542057
Phase
PHASE3
Status
Completed

Conditions

Eligibility Criteria

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

Interventions

  • Ensifentrine — DRUG
    Dosage Formulation: Ensifentrine Nebulizer suspension Dosage 3mg Frequency: Twice Daily for 24 weeks
  • Placebo — DRUG
    Dosage Formulation: Ensifentrine Placebo Nebulizer solution Frequency: Twice Daily for 24 weeks

Study Details

The purpose of this study is to determine if ensifentrine is safe and effective for the treatment of patients with moderate to severe Chronic Obstructive Pulmonary Disease (COPD).

Key Dates

First listed
Sep 9, 2020
Start date
Sep 22, 2020
Status verified
Oct 2023
Primary completion
May 3, 2022
Completion
Jul 6, 2022

Study Design

Enrollment
790 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Arm 1
    Ensifentrine Nebulized Suspension; 3 mg twice daily for 24 weeks
  • Placebo Comparator: Arm 2
    Ensifentrine Placebo Nebulized Solution; twice daily for 24 weeks

Primary Outcome Measure

Least Square (LS) Mean Change From Baseline in Average Forced Expiratory Volume in 1 Second (FEV1) Area Under the Curve Over 12 Hours (AUC0-12h) at Week 12 [ Time Frame: Baseline (40 minutes before first administration on Day 1) and Week 12 ]

Locations (77)

FacilityCityStateZIPSite coordinators
Wright Clinical Research, LLCAlabasterAlabama35007-
SEC Clinical ResearchAndalusiaAlabama36420-
Jasper Summit Research LLCJasperAlabama35501-
Elite Clinical Studies LLCPhoenixArizona85018-
Pulmonary Associates Clinical TrialsPhoenixArizona85006-
Clinical Research Institute of Arizona, LLCSun City WestArizona85375-
Premier Medical GroupBakersfieldCalifornia93309-
Antelope Valley Clinical TrialsLancasterCalifornia93534-
Downtown LA Research Center, Inc.Los AngelesCalifornia90017-
UCLA Medical CenterLos AngelesCalifornia90095-
California Medical Research AssociatesNorthridgeCalifornia91324-
Center for Clinical Trials of Sacramento, Inc.SacramentoCalifornia95823-
Institute of HealthCare Assessment, Inc.San DiegoCalifornia92120-
Integrated Research CenterSan DiegoCalifornia92117-
Alpine Clinical Research CenterBoulderColorado80301-
Clinical Research of West Florida, Inc.ClearwaterFlorida33765-
Innovative Research of West FloridaClearwaterFlorida33756-
Accel Research Sites - DeLand Clinical Research UnitDeLandFlorida32720-
Riverside Clinical ResearchEdgewaterFlorida32132-
Medical Research of Central FloridaLeesburgFlorida34748-
Axcess Medical ResearchLoxahatchee GrovesFlorida13005-
Advanced Medical Research InstituteMiamiFlorida33174-
Clinical Trials of Florida. LLCMiamiFlorida33186-
Research Institute of South FloridaMiamiFlorida33173-
South Medical Research Group, Inc.MiamiFlorida33186-
ProCare Clinical ResearchMiami GardensFlorida33014-
Florida Institute for Clinical ResearchOrlandoFlorida32825-
HMD Research, LLCOrlandoFlorida32819-
Sarasota Clinical ResearchSarasotaFlorida34239-
Coastal Pulmonary Critical CareSt. PetersburgFlorida33704-
Pasadena Center for Medical Research, LLCSt. PetersburgFlorida33707-
Clinical Research of West Florida, Inc.TampaFlorida33606-
Clinical Research Trials of Florida, Inc.TampaFlorida33607-
Florida Pulmonary Research Institute, LLCWinter ParkFlorida32789-
AMR New OrleansNew OrleansLouisiana70119-
Genesis Clin RES& ConsultingFall RiverMassachusetts02723-
Minnesota Lung CenterEdinaMinnesota55435-
Minnesota Lung CenterWoodburyMinnesota55125-
Midwest Chest ConsultantsSaint CharlesMissouri63301-
Montana Medical Research Inc.MissoulaMontana59808-
Mid Hudson Medical ResearchNew WindsorNew York12553-
CHEAR Center LLCThe BronxNew York10455-
American Health ResearchCharlotteNorth Carolina28277-
Carolina Clinical ResearchCharlotteNorth Carolina28273-
Clinical Research of GastoniaGastoniaNorth Carolina28054-
PharmQuest LLCGreensboroNorth Carolina27408-
Monroe Biomedical ResearchMonroeNorth Carolina28112-
Clinical Research of Lake NormanMooresvilleNorth Carolina28117-
Carolina Research Center, Inc.ShelbyNorth Carolina28150-
Aventiv Research Inc.ColumbusOhio43213-
Remington Davis Clinical ResearchColumbusOhio43215-
Aventiv ResearchDublinOhio43106-
OK Clinical Research, LLCEdmondOklahoma73034-
Velocity Clinical Research, Medford (Crisor, LLC)MedfordOregon97504-
Safe Harbor Clinical ResearchEast ProvidenceRhode Island02914-
VitaLink Research AndersonAndersonSouth Carolina29621-
Lowcountry Lung and Critical Care, P.A.CharlestonSouth Carolina29406-
VitaLink Research ColumbiaColumbiaSouth Carolina29204-
Piedmont Research PartnersFort MillSouth Carolina29707-
VitaLink Research GaffneyGaffneySouth Carolina29340-
VitaLink Research - GreenvilleGreenvilleSouth Carolina29615-
Clinical Research of Rock HillRock HillSouth Carolina29732-
Spartanburg Medical ResearchSpartanburgSouth Carolina29303-
VitaLink Research SpartanburgSpartanburgSouth Carolina29303-
CU Pharmaceutical ResearchUnionSouth Carolina29379-
MultiSpecialty Clinical Research, Inc.Johnson CityTennessee37601-
New Phase Research DevelopmentKnoxvilleTennessee37909-
PnP ResearchAmarilloTexas79106-
TTS ResearchBoerneTexas78006-
Corsicana Medical Research, PLLCCorsicanaTexas75110-
Houston Pulmonary and Sleep Allergy and Asthma AssociatesCypressTexas77429-
Metroplex Pulmonary and Sleep CenterMcKinneyTexas75069-
Diagnostics Research GroupSan AntonioTexas78229-
Element Research GroupSan AntonioTexas78258-
Sherman Clinical ResearchShermanTexas75092-
DM Clinical ResearchTomballTexas77375-
Manassas Clinical Research CenterManassasVirginia20110-

Find similar trials in Alabaster, AL

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By condition
COPD
By specialty
PulmonologyLung disease
By research site
Wright Clinical Research, LLC· Alabaster, ALSEC Clinical Research· Andalusia, ALJasper Summit Research LLC· Jasper, ALElite Clinical Studies LLC· Phoenix, AZPulmonary Associates Clinical Trials· Phoenix, AZClinical Research Institute of Arizona, LLC· Sun City West, AZ

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