A 52-Week Study of the Efficacy and Safety of BLU-5937 in Adults With Refractory Chronic Cough
- Registration Number
- NCT05599191
- Lead Sponsor
- Bellus Health Inc. - a GSK company
- Brief Summary
This is a randomized, double-blind, placebo-controlled, parallel-arm, Phase 3 study of BLU-5937 in participants with Refractory Chronic Cough (RCC).
- Detailed Description
The primary efficacy objective is to assess the effect of BLU-5937 on 24-hour cough frequency in adults with refractory chronic cough (including unexplained chronic cough) at 12 weeks.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 825
- Capable of giving signed informed consent
- Refractory chronic cough (including unexplained chronic cough) for at least one year
- Women of child-bearing potential must use a highly effective contraception method during the study and for at least 14 days after the last dose
- Current smoker/vaper (all forms of smoking and inhaled substances, including , cannabis/tobacco smoke and nicotine vapors) or individuals who have given up smoking within the past 6 months, or those with >20 pack-year smoking history
- Diagnosis of Chronic Obstructive Pulmonary Disease (COPD), bronchiectasis, idiopathic pulmonary fibrosis or uncontrolled asthma
- Respiratory tract infection within 4 weeks before screening
- Laboratory confirmed Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) infection at screening
- History of malignancy in the last 5 years
- History of alcohol or drug abuse within the last 3 years
- Has a positive serologic test for human immunodeficiency virus (HIV), hepatitis B virus surface antigen, or hepatitis C virus.
- Previous participation in a BLU-5937 trial
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description BLU-5937 25 mg BLU-5937 BLU-5937 oral dose 25 mg twice a day. BLU-5937 50 mg BLU-5937 BLU-5937 oral dose 50 mg twice a day. Placebo Placebo Matching Placebo for BLU-5937 oral dose twice a day.
- Primary Outcome Measures
Name Time Method 24-Hour Cough Frequency Week 12 Assessed using an ambulatory cough monitor
- Secondary Outcome Measures
Name Time Method Change from Baseline in Cough Severity Visual Analogue Scale at Week 12 Baseline, Week 12 Assessed by Cough Severity Visual Analogue Scale \[VAS\] by the participant on a 100 mm visual analog scale where higher scores indicate greater severity.
Percentage of Participants With ≥ 30mm Reduction, ≥ 20mm Reduction From Baseline in Cough Severity Visual Analog Scale (VAS) at Week 12 Baseline, Week 12 Assessed by Cough Severity Visual Analogue Scale \[VAS\] by the participant on a 100 mm visual analog scale where higher scores indicate greater severity.
Percentage of Participants With ≥30%, ≥50%, and ≥70% Reduction From Baseline in 24-Hour Cough Frequency at Week 12 Baseline, Week 12 Assessed using an ambulatory cough monitor
Change from Baseline in the Leicester Cough Questionnaire (LCQ) Total Score at Week 12 Baseline, Week 12 The LCQ is a patient-reported quality of life (QOL) measure of chronic cough. The questionnaire consists of 19 items to which the patient responds on a 7-point Likert response scale (from 1 to 7). Each item assesses symptoms during cough and the impact of cough on 3 domains: physical, psychological, and social. Domain scores range from 1-7, and the total score ranges from 3 - 21; a higher score indicates a better quality of life.
Percentage of Participants With a ≥1.3-point Increase From Baseline in Leicester Cough Questionnaire (LCQ) Total Score at Week 12 Baseline, Week 12 The LCQ is a patient-reported quality of life (QOL) measure of chronic cough. The questionnaire consists of 19 items to which the patient responds on a 7-point Likert response scale (from 1 to 7). Each item assesses symptoms during cough and the impact of cough on 3 domains: physical, psychological, and social. Domain scores range from 1-7, and the total score ranges from 3 - 21; a higher score indicates a better quality of life.
Trial Locations
- Locations (182)
Remington-Davis, Inc.
🇺🇸Columbus, Ohio, United States
Well Pharma Medical Research Corporation
🇺🇸Miami, Florida, United States
Dr JM Engelbrecht Trial Site
🇿🇦Somerset West, Western Cape, South Africa
Allergy Associates Medical Group, Inc.
🇺🇸San Diego, California, United States
Warren W. Pleskow, MD, 1071572
🇺🇸Encinitas, California, United States
Medical Research of Arizona
🇺🇸Scottsdale, Arizona, United States
Center for Clinical Trials, LLC
🇺🇸Paramount, California, United States
Sher Allergy
🇺🇸Largo, Florida, United States
Clinical Trial Network LLC
🇺🇸Houston, Texas, United States
Gwinnett Pulmonary Group P.C.
🇺🇸Lawrenceville, Georgia, United States
Metroplex Pulmonary and Sleep Center
🇺🇸McKinney, Texas, United States
Cordova Research Institute, LLC
🇺🇸Miami, Florida, United States
Allergy & Asthma Research of Southern California
🇺🇸Mission Viejo, California, United States
PMG Research of DuPage Medical Group
🇺🇸Downers Grove, Illinois, United States
Coral Research Clinic corp
🇺🇸Miami, Florida, United States
Universitair Ziekenhuis Gent
🇧🇪Gent, Belgium
Instituto Medico Fundación Grupo Colaborativo Rosario Investigación y Prevención Medica
🇦🇷Rosario, Santa Fe, Argentina
Temple Lung Center
🇺🇸Philadelphia, Pennsylvania, United States
Life Spring Research Foundation
🇺🇸Miami, Florida, United States
Sneeze, Wheeze and Itch Associates, LLC
🇺🇸Normal, Illinois, United States
C. H. R. de la Citadelle
🇧🇪Liège, Belgium
The Community Research of South Florida
🇺🇸Hialeah, Florida, United States
Pharmaceutical Research & Consulting, Inc.
🇺🇸Dallas, Texas, United States
Cliniques Universitaires Saint-Luc
🇧🇪Bruxelles, Belgium
Kelowna Respirology and Asthma Research
🇨🇦Kelowna, British Columbia, Canada
Accellacare Bristol
🇺🇸Bristol, Tennessee, United States
Instituto Medico de la Fundacion Estudios Clinicos
🇦🇷Rosario, Santa Fe, Argentina
Clinique de pneumologie et du sommeil de Lanaudière
🇨🇦Saint-Charles-Borromée, Quebec, Canada
Burlington Lung Clinic
🇨🇦Burlington, Ontario, Canada
Velocity Clinical Research
🇺🇸Medford, Oregon, United States
Montreal Chest Institute
🇨🇦Montréal, Quebec, Canada
Noordwest Ziekenhuisgroep
🇳🇱Alkmaar, Netherlands
Gelre Ziekenhuizen, Zutphen
🇳🇱Zutphen, Netherlands
AZ Sint-Maarten
🇧🇪Mechelen, Belgium
Centrum Medyczne Lucyna Andrzej Dymek s.c.
🇵🇱Zawadzkie, Poland
Isala Klinieken, Weezenlanden
🇳🇱Zwolle, Netherlands
Kocaeli Universitesi - Kocaeli Universitesi Tip Fakultesi
🇹🇷İzmit, Turkey
Hospital Italiano de Buenos Aires
🇦🇷Ciudad Autonoma Buenos Aires, Argentina
Hospital de la Santa Creu i Sant Pau
🇪🇸Barcelona, Spain
Instituto del Buen Aire
🇦🇷Santa Fe, Argentina
Fundacion Scherbovsky
🇦🇷Mendoza, Argentina
Hospital Universitario Clinico San Carlos
🇪🇸Madrid, Spain
Instituto Medico DAMIC
🇦🇷Cordoba, Argentina
Amphia Ziekenhuis, Molengracht
🇳🇱Breda, Netherlands
Institute of Medical Sciences and SUM Hospital
🇮🇳Bhubaneswar, Orissa, India
Prywatny Gabinet Internistyczno-Alergologiczny
🇵🇱Białystok, Poland
Dynamic Drug Advancement
🇨🇦Ajax, Ontario, Canada
Aashirwad Hospital
🇮🇳Ulhasnagar, Maharashtra, India
Bernhoven Uden
🇳🇱Uden, Netherlands
Accellacare España SL
🇪🇸Alcobendas, Madrid, Spain
Suyog Multispeciality Hospital
🇮🇳Nashik, Maharashtra, India
Uniwersytecki Szpital Kliniczny nr 1 im. N. Barlickiego w Lodzi
🇵🇱Łódź, Poland
CISSS de la Monteregie-Centre
🇨🇦Greenfield Park, Quebec, Canada
Worthwhile Clinical Trials
🇿🇦Johannesburg, Gauteng, South Africa
DIEX Recherche Victoriaville Inc.
🇨🇦Victoriaville, Quebec, Canada
Shetty Hospital
🇮🇳Bengaluru, Karnataka, India
ACE Hospital and Research Centre
🇮🇳Pune, Masharashtra, India
Siddhi Hospital
🇮🇳Nashik, Maharashtra, India
Da Vinci Maganklinika
🇭🇺Pécs, Hungary
Bhaktivedanta Hospital and Research Institute
🇮🇳Thāne, Maharashtra, India
Mersin University Medical Faculty
🇹🇷Mersin, Turkey
Accellacare South London
🇬🇧Orpington, Kent, United Kingdom
Accellacare North London
🇬🇧Northwood, Middlesex, United Kingdom
Hopital Européen de Marseille
🇫🇷Marseille, Bouches-du-Rhône, France
CHU de Dijon - Hôpital François Mitterand
🇫🇷Dijon cedex, Côte-d'Or, France
Asthma Bhavan
🇮🇳Jaipur, Rajasthan, India
Hôpital Nord - CHU Marseille
🇫🇷Marseille, Bouches-du-Rhône, France
Dr NK Gounden Medi-Centre
🇿🇦Durban, KwaZulu-Natal, South Africa
Eastern Virginia Medical School
🇺🇸Norfolk, Virginia, United States
Hopital Arnaud de Villeneuve
🇫🇷Montpellier cedex 5, Herault, France
Clinique Specialisee en Allergie de la Capitale
🇨🇦Québec, Quebec, Canada
Hospital Universitario de La Princesa
🇪🇸Madrid, Spain
Care Access Research
🇺🇸Aurora, Colorado, United States
University of Oklahoma Health Sciences Center
🇺🇸Oklahoma City, Oklahoma, United States
Allergy Associates Research Center
🇺🇸Portland, Oregon, United States
Diagnostics Research Group, LLC
🇺🇸San Antonio, Texas, United States
University of Utah Hospitals & Clinics
🇺🇸Salt Lake City, Utah, United States
PMG Research of Charleston, LLC
🇺🇸Mount Pleasant, South Carolina, United States
Clinical Research Associates of Central PA, LLC
🇺🇸DuBois, Pennsylvania, United States
McFarland Clinic P.C.
🇺🇸Ames, Iowa, United States
University of Calgary - Health Sciences Centre
🇨🇦Calgary, Alberta, Canada
AAPRI Clinical Research Institute
🇺🇸Warwick, Rhode Island, United States
PMG Research of Knoxville
🇺🇸Knoxville, Tennessee, United States
Main Street Physician's Care - Waterway
🇺🇸Little River, South Carolina, United States
Inspiration Research Limited
🇨🇦Toronto, Ontario, Canada
Allergy Asthma Research Institute
🇺🇸Waco, Texas, United States
Insares S.A.
🇦🇷Mendoza, Argentina
University of Kansas Medical Center Research Institute, Inc.
🇺🇸Wichita, Kansas, United States
Hadassah University Hospital - Ein Kerem
🇮🇱Jerusalem, Israel
Jasper Summit Research, LLC
🇺🇸Jasper, Alabama, United States
Research Solutions of Arizona, PC
🇺🇸Litchfield Park, Arizona, United States
Little Rock Allergy & Asthma, P.A. Clinical Research Center
🇺🇸Little Rock, Arkansas, United States
Innovative Research of West Florida, Inc.
🇺🇸Clearwater, Florida, United States
Omega Research Consultants
🇺🇸DeBary, Florida, United States
University of Iowa Hospitals & Clinics
🇺🇸Iowa City, Iowa, United States
Cotton O'Neil Clinical Research Center
🇺🇸Topeka, Kansas, United States
Avant Research Associates, LLC
🇺🇸Crowley, Louisiana, United States
The Asthma and Allergy Center
🇺🇸Bellevue, Nebraska, United States
Infinity Medical Research Inc
🇺🇸North Dartmouth, Massachusetts, United States
PMG Research of Raleigh
🇺🇸Raleigh, North Carolina, United States
American Health Research, Inc.
🇺🇸Charlotte, North Carolina, United States
PMG Research of Salisbury, LLC
🇺🇸Salisbury, North Carolina, United States
PMG Research of Rocky Mount, LLC
🇺🇸Rocky Mount, North Carolina, United States
Vital Prospects Clinical Research Institute, P.C.
🇺🇸Tulsa, Oklahoma, United States
University of Texas Health Science Center at Houston
🇺🇸Houston, Texas, United States
Clinical Research of Rock Hill
🇺🇸Rock Hill, South Carolina, United States
Bellingham Asthma, Allergy & Immunology Clinic
🇺🇸Bellingham, Washington, United States
Expertia S.A- Mautalen Salud e Investigación
🇦🇷Ciudad Autonoma Buenos Aires, Buenos Aires, Argentina
CINME - Centro De Investigaciones Metabolicas
🇦🇷Ciudad Autonoma de Buenos Aire, Buenos Aires, Argentina
TPMG Clinical Research Williamsburg
🇺🇸Williamsburg, Virginia, United States
Centro de Investigaciones Medicas Mar del Plata
🇦🇷Mar del Plata, Buenos Aires, Argentina
APRILLUS Asistencia e Investigacion
🇦🇷Ciudad Autonoma de Buenos Aires, Ciudad Autonoma Buenos Aires, Argentina
CEMER - Centro Medico de Enfermedades Respiratorias
🇦🇷Vicente López, Buenos Aires, Argentina
Peak Research Group
🇨🇦Calgary, Alberta, Canada
Hamilton Medical Research Group
🇨🇦Hamilton, Ontario, Canada
McMaster University Health Sciences Center
🇨🇦Hamilton, Ontario, Canada
Dr. Syed Anees Medicine Professional Corporation
🇨🇦Windsor, Ontario, Canada
DIEX Recherche Quebec Inc.
🇨🇦Québec, Quebec, Canada
Institut Universitaire de Cardiologie et de Pneumologie de Quebec
🇨🇦Québec, Quebec, Canada
CIC Mauricie Inc.
🇨🇦Trois-Rivières, Quebec, Canada
Recherche GCP Research
🇨🇦Montréal, Canada
Asociacion IPS Medicos Internistas de Caldas
🇨🇴Manizales, Colombia
Fundación Cardiovascular de Colombia - Instituto del Corazón Floridablanca
🇨🇴Floridablanca, Colombia
Clinica SOMER
🇨🇴Medellín, Colombia
Hospital Pablo Tobón Uribe
🇨🇴Medellín, Colombia
CHU de Strasbourg - Nouvel Hôpital Civil
🇫🇷Strasbourg, Bas Rhin, France
Fundacion Centro de Investigacion Clinica CIC
🇨🇴Medellín, Colombia
Hopital Albert Calmette CHU Lille
🇫🇷Lille, France
Hopital Larrey
🇫🇷Toulouse, Haute Garonne, France
Szalay Janos Rendelointezet
🇭🇺Hajdunanas, Hungary
DRC Gyogyszervizsgalo Kozpont Kft.
🇭🇺Balatonfüred, Hungary
Hôpital Cochin
🇫🇷Paris, France
Clinexpert Kft.
🇭🇺Budapest, Hungary
Omnimodus Elixir Kft.
🇭🇺Csorna, Hungary
Erzsebet Gondozohaz Kft.
🇭🇺Gödöllő, Hungary
Puspokladanyi Egeszsegugyi Szolgaltato Nonprofit Kft.
🇭🇺Püspökladány, Hungary
The Lady Davis Carmel Medical Center
🇮🇱Haifa, Israel
Rabin Medical Center-Beilinson Campus
🇮🇱Petach Tikva, Israel
Hillel Yaffe Medical Center
🇮🇱Hadera, Israel
Sheba Medical Center
🇮🇱Ramat Gan, Israel
Tel Aviv Sourasky Medical Center
🇮🇱Tel Aviv, Israel
Rijnstate
🇳🇱Arnhem, Netherlands
Centrum Medyczne Pratia Bydgoszcz
🇵🇱Bydgoszcz, Poland
Center of Innovative Therapies
🇵🇱Piaseczno, Poland
Alergo-Med Specjalistyczna Przychodnia Lekarska Sp. Z .O.O.
🇵🇱Tarnów, Poland
Uniwersytecki Szpital Kliniczny nr 1 im. Norberta Barlickiego
🇵🇱Łódź, Poland
Iatros International
🇿🇦Bloemfontein, Free State, South Africa
Smith, C - Morningside Hospital
🇿🇦Johannesburg, Gauteng, South Africa
Botho ke Bontle Health Services
🇿🇦Pretoria, Gauteng, South Africa
TASK Eden
🇿🇦George, Western Cape, South Africa
Global Clinical Trials
🇿🇦Pretoria, Gauteng, South Africa
Complejo Hospitalario Universitario de Santiago
🇪🇸Santiago De Compostela, La Coruña, Spain
Hospital Clinic de Barcelona
🇪🇸Barcelona, Spain
Hospital Universitario Quironsalud Madrid
🇪🇸Pozuelo De Alarcón, Madrid, Spain
Hospital General Universitario Gregorio Marañon
🇪🇸Madrid, Spain
Hospital Clinico Universitario Virgen de la Victoria
🇪🇸Málaga, Spain
Yedikule Pulmonary Dis. and Surgery Edu. and Res. Hosp.
🇹🇷Istanbul, Turkey
Ege University Medical Faculty
🇹🇷İzmir, Turkey
Sureyyapasa Pulmonary Diseases and Cardiothoracic Surgery Education and Research Hospital
🇹🇷Istanbul, Turkey
Hospital Quironsalud Malaga
🇪🇸Málaga, Spain
Wythenshawe Hospital
🇬🇧Wythenshawe, Greater Manchester, United Kingdom
TC SBU Izmir Dr Suat Seren Gogus Hastaliklari ve Cerrahisi Egitim ve Arastirma
🇹🇷Yenişehir, Turkey
Accellacare Yorkshire
🇬🇧Shipley, Bedfordshire, United Kingdom
West Walk Surgery
🇬🇧Bristol, United Kingdom
Norfolk and Norwich University Hospital
🇬🇧Norwich, Norfolk, United Kingdom
Belfast City Hospital
🇬🇧Belfast, United Kingdom
Lakeside Healthcare
🇬🇧Corby, Northamptonshire, United Kingdom
The Curators of the University of Missouri on behalf of University of Missouri Health Care
🇺🇸Columbia, Missouri, United States
Indraprastha Apollo Hospitals
🇮🇳Delhi, India
Prywatny Gabinet Lekarski
🇵🇱Rzeszów, Poland
Montana Medical Research, Inc.
🇺🇸Missoula, Montana, United States
Ostrowieckie Centrum Medyczne spółka cywilna Anna Olech-Cudzik, Krzysztof Cudzik
🇵🇱Ostrowiec Świętokrzyski, Poland
Instituto de Especialidades de la Salud Rosario
🇦🇷Rosario, Santa Fe, Argentina
Pandit Bhagwat Dayal Sharma Post Graduate Institute of Medical Sciences
🇮🇳Rohtak, Haryana, India
Calcutta Medical Research Institute
🇮🇳Kolkata, West Bengal, India
Holderness Health
🇬🇧Hull, East Riding Of Yorkshire, United Kingdom
Michigan Medicine Investigational Drug Services
🇺🇸Ann Arbor, Michigan, United States
Southeastern Research Center LLC
🇺🇸Winston-Salem, North Carolina, United States
Lowcountry Lung and Critical Care, P.A.
🇺🇸Charleston, South Carolina, United States
North Florida Foundation for Research and Education, Inc.
🇺🇸Gainesville, Florida, United States
Montefiore Medical Center (MMC)
🇺🇸Bronx, New York, United States
Royal Brompton Hospital
🇬🇧London, Greater London, United Kingdom