A 52-Week Study of the Efficacy and Safety of BLU-5937 in Adults With Refractory Chronic Cough

Last updated: February 14, 2024
Sponsor: Bellus Health Inc. - a GSK company
Overall Status: Active - Recruiting

Phase

3

Condition

N/A

Treatment

Placebo

BLU-5937

Clinical Study ID

NCT05599191
221850
BUS-P3-01
  • Ages 18-80
  • All Genders

Study Summary

This is a randomized, double-blind, placebo-controlled, parallel-arm, Phase 3 study of BLU-5937 in participants with Refractory Chronic Cough (RCC).

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • 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 methodduring the study and for at least 14 days after the last dose

Exclusion

Exclusion Criteria:

  • Current smoker/vaper (all forms of smoking and inhaled substances, including ,cannabis/tobacco smoke and nicotine vapors) or individuals who have given up smokingwithin the past 6 months, or those with >20 pack-year smoking history
  • Diagnosis of Chronic Obstructive Pulmonary Disease (COPD), bronchiectasis, idiopathicpulmonary 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 Bvirus surface antigen, or hepatitis C virus.
  • Previous participation in a BLU-5937 trial

Study Design

Total Participants: 825
Treatment Group(s): 2
Primary Treatment: Placebo
Phase: 3
Study Start date:
October 25, 2022
Estimated Completion Date:
March 31, 2026

Study 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.

Connect with a study center

  • Expertia S.A- Mautalen Salud e Investigación

    Ciudad Autonoma Buenos Aires, Buenos Aires C1128AAF
    Argentina

    Active - Recruiting

  • CINME - Centro De Investigaciones Metabolicas

    Ciudad Autonoma de Buenos Aire, Buenos Aires C1056ABJ
    Argentina

    Active - Recruiting

  • Centro de Investigaciones Medicas Mar del Plata

    Mar del Plata, Buenos Aires B7600FYK
    Argentina

    Active - Recruiting

  • CEMER - Centro Medico de Enfermedades Respiratorias

    Vicente López, Buenos Aires 1602
    Argentina

    Site Not Available

  • APRILLUS Asistencia e Investigacion

    Ciudad Autonoma de Buenos Aires, Ciudad Autonoma Buenos Aires C1406AGA
    Argentina

    Active - Recruiting

  • Instituto Medico Fundación Grupo Colaborativo Rosario Investigación y Prevención Medica

    Rosario, Santa Fe 2000
    Argentina

    Active - Recruiting

  • Instituto Medico de la Fundacion Estudios Clinicos

    Rosario, Santa Fe S2000DEJ
    Argentina

    Active - Recruiting

  • Instituto de Especialidades de la Salud Rosario

    Rosario, Santa Fe 2000
    Argentina

    Active - Recruiting

  • Hospital Italiano de Buenos Aires

    Ciudad Autonoma Buenos Aires, C199AAB
    Argentina

    Site Not Available

  • Instituto Medico DAMIC

    Cordoba, X5003DCE
    Argentina

    Active - Recruiting

  • Fundacion Scherbovsky

    Mendoza, 5500
    Argentina

    Active - Recruiting

  • Insares S.A.

    Mendoza, 5500
    Argentina

    Active - Recruiting

  • Instituto del Buen Aire

    Santa Fe, 3000
    Argentina

    Active - Recruiting

  • Cliniques Universitaires Saint-Luc

    Bruxelles, 1200
    Belgium

    Active - Recruiting

  • Universitair Ziekenhuis Gent

    Gent, 9000
    Belgium

    Active - Recruiting

  • UZ Leuven

    Leuven, 3000
    Belgium

    Site Not Available

  • C. H. R. de la Citadelle

    Liège, 4000
    Belgium

    Active - Recruiting

  • AZ Sint-Maarten

    Mechelen, 2800
    Belgium

    Active - Recruiting

  • Peak Research Group

    Calgary, Alberta T3E 7M8
    Canada

    Active - Recruiting

  • University of Calgary - Health Sciences Centre

    Calgary, Alberta T2N 1N4
    Canada

    Active - Recruiting

  • Kelowna Respirology and Asthma Research

    Kelowna, British Columbia V1Y3H5
    Canada

    Active - Recruiting

  • Dynamic Drug Advancement

    Ajax, Ontario L1S 2J5
    Canada

    Active - Recruiting

  • Burlington Lung Clinic

    Burlington, Ontario L7N 3V2
    Canada

    Active - Recruiting

  • Hamilton Medical Research Group

    Hamilton, Ontario L8M 1K7
    Canada

    Active - Recruiting

  • McMaster University Health Sciences Center

    Hamilton, Ontario L8N 3Z5
    Canada

    Active - Recruiting

  • Inspiration Research Limited

    Toronto, Ontario M5T 3A9
    Canada

    Active - Recruiting

  • Dr. Syed Anees Medicine Professional Corporation

    Windsor, Ontario N8X 1T3
    Canada

    Active - Recruiting

  • CISSS de la Monteregie-Centre

    Greenfield Park, Quebec J4V 2H1
    Canada

    Site Not Available

  • Montreal Chest Institute

    Montréal, Quebec H4A 3J1
    Canada

    Site Not Available

  • Clinique Specialisee en Allergie de la Capitale

    Québec, Quebec G1V 4W2
    Canada

    Active - Recruiting

  • DIEX Recherche Quebec Inc.

    Québec, Quebec G1V 4T3
    Canada

    Active - Recruiting

  • Institut Universitaire de Cardiologie et de Pneumologie de Quebec

    Québec, Quebec G1V 4G5
    Canada

    Active - Recruiting

  • Clinique de pneumologie et du sommeil de Lanaudière

    Saint-Charles-Borromée, Quebec J6E 2B4
    Canada

    Active - Recruiting

  • CIC Mauricie Inc.

    Trois-Rivières, Quebec G8T 7A1
    Canada

    Active - Recruiting

  • DIEX Recherche Victoriaville Inc.

    Victoriaville, Quebec G6P 6P6
    Canada

    Active - Recruiting

  • Recherche GCP Research

    Montréal, H1M 1B1
    Canada

    Active - Recruiting

  • Fundación Cardiovascular de Colombia - Instituto del Corazón Floridablanca

    Floridablanca,
    Colombia

    Active - Recruiting

  • Asociacion IPS Medicos Internistas de Caldas

    Manizales,
    Colombia

    Active - Recruiting

  • Clinica SOMER

    Medellín,
    Colombia

    Active - Recruiting

  • Fundacion Centro de Investigacion Clinica CIC

    Medellín,
    Colombia

    Active - Recruiting

  • Hospital Pablo Tobón Uribe

    Medellín,
    Colombia

    Active - Recruiting

  • CHU de Strasbourg - Nouvel Hôpital Civil

    Strasbourg, Bas Rhin 67091
    France

    Active - Recruiting

  • Hopital Européen de Marseille

    Marseille, Bouches-du-Rhône 13003
    France

    Active - Recruiting

  • Hôpital Nord - CHU Marseille

    Marseille, Bouches-du-Rhône 13015
    France

    Active - Recruiting

  • CHU de Dijon - Hôpital François Mitterand

    Dijon cedex, Côte-d'Or 21000
    France

    Active - Recruiting

  • Hopital Larrey

    Toulouse, Haute Garonne 31000
    France

    Active - Recruiting

  • Hopital Arnaud de Villeneuve

    Montpellier cedex 5, Herault 34295
    France

    Active - Recruiting

  • Hopital Albert Calmette CHU Lille

    Lille, 59000
    France

    Site Not Available

  • Hôpital Cochin

    Paris, 775014
    France

    Active - Recruiting

  • DRC Gyogyszervizsgalo Kozpont Kft.

    Balatonfüred, 8230
    Hungary

    Active - Recruiting

  • Clinexpert Kft.

    Budapest, 1033
    Hungary

    Active - Recruiting

  • Omnimodus Elixir Kft.

    Csorna, 9300
    Hungary

    Active - Recruiting

  • Erzsebet Gondozohaz Kft.

    Gödöllő, 2100
    Hungary

    Active - Recruiting

  • Szalay Janos Rendelointezet

    Hajdunanas, 4080
    Hungary

    Active - Recruiting

  • Da Vinci Maganklinika

    Pécs, 7635
    Hungary

    Active - Recruiting

  • Puspokladanyi Egeszsegugyi Szolgaltato Nonprofit Kft.

    Püspökladány, 4150
    Hungary

    Active - Recruiting

  • Pandit Bhagwat Dayal Sharma Post Graduate Institute of Medical Sciences

    Rohtak, Haryana 124514
    India

    Active - Recruiting

  • Shetty Hospital

    Bengaluru, Karnataka 560068
    India

    Active - Recruiting

  • Siddhi Hospital

    Nashik, Maharashtra 422007
    India

    Active - Recruiting

  • Suyog Multispeciality Hospital

    Nashik, Maharashtra 422009
    India

    Active - Recruiting

  • Bhaktivedanta Hospital and Research Institute

    Thāne, Maharashtra 401107
    India

    Active - Recruiting

  • Aashirwad Hospital

    Ulhasnagar, Maharashtra 421001
    India

    Active - Recruiting

  • ACE Hospital and Research Centre

    Pune, Masharashtra 411004
    India

    Active - Recruiting

  • Institute of Medical Sciences and SUM Hospital

    Bhubaneswar, Orissa 751003
    India

    Site Not Available

  • Asthma Bhavan

    Jaipur, Rajasthan 302023
    India

    Active - Recruiting

  • Calcutta Medical Research Institute

    Kolkata, West Bengal 700027
    India

    Active - Recruiting

  • Indraprastha Apollo Hospitals

    Delhi, 110076
    India

    Active - Recruiting

  • Hillel Yaffe Medical Center

    Hadera, 169
    Israel

    Active - Recruiting

  • The Lady Davis Carmel Medical Center

    Haifa, 3436212
    Israel

    Active - Recruiting

  • Hadassah University Hospital - Ein Kerem

    Jerusalem, 9112001
    Israel

    Active - Recruiting

  • Mersin University Medical Faculty

    Mersin, 33079
    Israel

    Site Not Available

  • Rabin Medical Center-Beilinson Campus

    Petach Tikva, 4941492
    Israel

    Active - Recruiting

  • Sheba Medical Center

    Ramat Gan,
    Israel

    Active - Recruiting

  • Tel Aviv Sourasky Medical Center

    Tel Aviv, 6423906
    Israel

    Active - Recruiting

  • Noordwest Ziekenhuisgroep

    Alkmaar, 1815 JD
    Netherlands

    Active - Recruiting

  • Rijnstate

    Arnhem, 6815 AD
    Netherlands

    Active - Recruiting

  • Amphia Ziekenhuis, Molengracht

    Breda, 4818 CK
    Netherlands

    Active - Recruiting

  • Bernhoven Uden

    Uden, 5406 PT
    Netherlands

    Active - Recruiting

  • Gelre Ziekenhuizen, Zutphen

    Zutphen, 7207 AE
    Netherlands

    Active - Recruiting

  • Isala Klinieken, Weezenlanden

    Zwolle, 8025 AB
    Netherlands

    Active - Recruiting

  • Prywatny Gabinet Internistyczno-Alergologiczny

    Białystok, 15-025
    Poland

    Active - Recruiting

  • Centrum Medyczne Pratia Bydgoszcz

    Bydgoszcz, 85-796
    Poland

    Active - Recruiting

  • Ostrowieckie Centrum Medyczne spółka cywilna Anna Olech-Cudzik, Krzysztof Cudzik

    Ostrowiec Świętokrzyski, 27-400
    Poland

    Active - Recruiting

  • Center of Innovative Therapies

    Piaseczno, 05-500
    Poland

    Active - Recruiting

  • Prywatny Gabinet Lekarski

    Rzeszów, 35-051
    Poland

    Active - Recruiting

  • Alergo-Med Specjalistyczna Przychodnia Lekarska Sp. Z .O.O.

    Tarnów, 33-100
    Poland

    Active - Recruiting

  • Centrum Medyczne Lucyna Andrzej Dymek s.c.

    Zawadzkie, 47-120
    Poland

    Active - Recruiting

  • Uniwersytecki Szpital Kliniczny nr 1 im. N. Barlickiego w Lodzi

    Łódź, 90-153
    Poland

    Active - Recruiting

  • Uniwersytecki Szpital Kliniczny nr 1 im. Norberta Barlickiego

    Łódź, 90-141
    Poland

    Active - Recruiting

  • Iatros International

    Bloemfontein, Free State 9301
    South Africa

    Active - Recruiting

  • Smith, C - Morningside Hospital

    Johannesburg, Gauteng 2060
    South Africa

    Active - Recruiting

  • Worthwhile Clinical Trials

    Johannesburg, Gauteng 1500
    South Africa

    Active - Recruiting

  • Botho ke Bontle Health Services

    Pretoria, Gauteng 0122
    South Africa

    Active - Recruiting

  • Global Clinical Trials

    Pretoria, Gauteng 0001
    South Africa

    Site Not Available

  • Dr NK Gounden Medi-Centre

    Durban, KwaZulu-Natal 4093
    South Africa

    Active - Recruiting

  • TASK Eden

    George, Western Cape 6530
    South Africa

    Active - Recruiting

  • Dr JM Engelbrecht Trial Site

    Somerset West, Western Cape 7130
    South Africa

    Active - Recruiting

  • Complejo Hospitalario Universitario de Santiago

    Santiago De Compostela, La Coruña 15706
    Spain

    Active - Recruiting

  • Accellacare España SL

    Alcobendas, Madrid 28100
    Spain

    Active - Recruiting

  • Hospital Universitario Quironsalud Madrid

    Pozuelo De Alarcón, Madrid 28223
    Spain

    Active - Recruiting

  • Hospital Clinic de Barcelona

    Barcelona, 08036
    Spain

    Active - Recruiting

  • Hospital de la Santa Creu i Sant Pau

    Barcelona, 08025
    Spain

    Active - Recruiting

  • Hospital General Universitario Gregorio Marañon

    Madrid, 28007
    Spain

    Active - Recruiting

  • Hospital Universitario Clinico San Carlos

    Madrid, 28040
    Spain

    Site Not Available

  • Hospital Universitario de La Princesa

    Madrid, 28006
    Spain

    Active - Recruiting

  • Hospital Clinico Universitario Virgen de la Victoria

    Málaga, 29004
    Spain

    Active - Recruiting

  • Hospital Quironsalud Malaga

    Málaga, 29004
    Spain

    Active - Recruiting

  • Sureyyapasa Pulmonary Diseases and Cardiothoracic Surgery Education and Research Hospital

    Istanbul, 34844
    Turkey

    Site Not Available

  • Yedikule Pulmonary Dis. and Surgery Edu. and Res. Hosp.

    Istanbul, 34020
    Turkey

    Site Not Available

  • Mersin University Medical Faculty

    Mersin, 33079
    Turkey

    Site Not Available

  • TC SBU Izmir Dr Suat Seren Gogus Hastaliklari ve Cerrahisi Egitim ve Arastirma

    Yenişehir, 35110
    Turkey

    Site Not Available

  • Ege University Medical Faculty

    İzmir, 35100
    Turkey

    Site Not Available

  • Kocaeli Universitesi - Kocaeli Universitesi Tip Fakultesi

    İzmit, 41380
    Turkey

    Site Not Available

  • Accellacare Yorkshire

    Shipley, Bedfordshire BD18 3SA
    United Kingdom

    Active - Recruiting

  • Holderness Health

    Hull, East Riding Of Yorkshire HU10 7TR
    United Kingdom

    Active - Recruiting

  • Royal Brompton Hospital

    London, Greater London SW3 6NP
    United Kingdom

    Active - Recruiting

  • Wythenshawe Hospital

    Wythenshawe, Greater Manchester M23 9LT
    United Kingdom

    Active - Recruiting

  • Accellacare South London

    Orpington, Kent BR5 3QG
    United Kingdom

    Active - Recruiting

  • Accellacare North London

    Northwood, Middlesex HA6 2RN
    United Kingdom

    Active - Recruiting

  • Norfolk and Norwich University Hospital

    Norwich, Norfolk NR4 7UY
    United Kingdom

    Site Not Available

  • Lakeside Healthcare

    Corby, Northamptonshire NN17 2UR
    United Kingdom

    Active - Recruiting

  • Belfast City Hospital

    Belfast, BT9 7AB
    United Kingdom

    Active - Recruiting

  • West Walk Surgery

    Bristol, BS37 4AX
    United Kingdom

    Active - Recruiting

  • Jasper Summit Research, LLC

    Jasper, Alabama 35501
    United States

    Site Not Available

  • Research Solutions of Arizona, PC

    Litchfield Park, Arizona 85340
    United States

    Active - Recruiting

  • Medical Research of Arizona

    Scottsdale, Arizona 85248
    United States

    Active - Recruiting

  • Little Rock Allergy & Asthma, P.A. Clinical Research Center

    Little Rock, Arkansas 72205
    United States

    Active - Recruiting

  • Warren W. Pleskow, MD, 1071572

    Encinitas, California 92024
    United States

    Active - Recruiting

  • Allergy & Asthma Research of Southern California

    Mission Viejo, California 92691
    United States

    Active - Recruiting

  • Center for Clinical Trials, LLC

    Paramount, California 90723
    United States

    Active - Recruiting

  • Allergy Associates Medical Group, Inc.

    San Diego, California 92120
    United States

    Active - Recruiting

  • Care Access Research

    Aurora, Colorado 80012
    United States

    Active - Recruiting

  • Innovative Research of West Florida, Inc.

    Clearwater, Florida 33756
    United States

    Active - Recruiting

  • Omega Research Consultants

    DeBary, Florida 32713
    United States

    Active - Recruiting

  • North Florida Foundation for Research and Education, Inc.

    Gainesville, Florida 32608
    United States

    Site Not Available

  • The Community Research of South Florida

    Hialeah, Florida 33016
    United States

    Active - Recruiting

  • Sher Allergy

    Largo, Florida 33778
    United States

    Site Not Available

  • Coral Research Clinic corp

    Miami, Florida 33175
    United States

    Active - Recruiting

  • Cordova Research Institute, LLC

    Miami, Florida 33155
    United States

    Active - Recruiting

  • Life Spring Research Foundation

    Miami, Florida 33155
    United States

    Active - Recruiting

  • Well Pharma Medical Research Corporation

    Miami, Florida 33173
    United States

    Active - Recruiting

  • Miami Beach Clinical Research Center

    Miami Beach, Florida 33141
    United States

    Site Not Available

  • Gwinnett Pulmonary Group P.C.

    Lawrenceville, Georgia 30045
    United States

    Active - Recruiting

  • PMG Research of DuPage Medical Group

    Downers Grove, Illinois 60515
    United States

    Active - Recruiting

  • Sneeze, Wheeze and Itch Associates, LLC

    Normal, Illinois 61761
    United States

    Active - Recruiting

  • McFarland Clinic P.C.

    Ames, Iowa 50010
    United States

    Active - Recruiting

  • University of Iowa Hospitals & Clinics

    Iowa City, Iowa 52242
    United States

    Active - Recruiting

  • University of Kansas Medical Center Research Institute, Inc.

    Kansas City, Kansas 66160
    United States

    Active - Recruiting

  • Cotton O'Neil Clinical Research Center

    Topeka, Kansas 66606
    United States

    Active - Recruiting

  • University of Kansas Medical Center Research Institute, Inc.

    Wichita, Kansas 67214
    United States

    Active - Recruiting

  • Avant Research Associates, LLC

    Crowley, Louisiana 70526
    United States

    Active - Recruiting

  • Infinity Medical Research Inc

    North Dartmouth, Massachusetts 02747
    United States

    Active - Recruiting

  • Michigan Medicine Investigational Drug Services

    Ann Arbor, Michigan 48109
    United States

    Active - Recruiting

  • The Curators of the University of Missouri on behalf of University of Missouri Health Care

    Columbia, Missouri 65203
    United States

    Active - Recruiting

  • Montana Medical Research, Inc.

    Missoula, Montana 59808
    United States

    Active - Recruiting

  • The Asthma and Allergy Center

    Bellevue, Nebraska 68123
    United States

    Active - Recruiting

  • Montefiore Medical Center (MMC)

    Bronx, New York 10461
    United States

    Active - Recruiting

  • American Health Research, Inc.

    Charlotte, North Carolina 28277
    United States

    Active - Recruiting

  • PMG Research of Raleigh

    Raleigh, North Carolina 27609
    United States

    Active - Recruiting

  • PMG Research of Rocky Mount, LLC

    Rocky Mount, North Carolina 27804
    United States

    Active - Recruiting

  • PMG Research of Salisbury, LLC

    Salisbury, North Carolina 28144
    United States

    Active - Recruiting

  • Southeastern Research Center LLC

    Winston-Salem, North Carolina 27103
    United States

    Active - Recruiting

  • Cleveland Clinic

    Cleveland, Ohio 44195
    United States

    Site Not Available

  • Remington-Davis, Inc.

    Columbus, Ohio 43215
    United States

    Active - Recruiting

  • University of Oklahoma Health Sciences Center

    Oklahoma City, Oklahoma 73104
    United States

    Active - Recruiting

  • Vital Prospects Clinical Research Institute, P.C.

    Tulsa, Oklahoma 74136
    United States

    Active - Recruiting

  • Velocity Clinical Research

    Medford, Oregon 97504
    United States

    Active - Recruiting

  • Allergy Associates Research Center

    Portland, Oregon 97213
    United States

    Active - Recruiting

  • Clinical Research Associates of Central PA, LLC

    DuBois, Pennsylvania 15801
    United States

    Active - Recruiting

  • Temple Lung Center

    Philadelphia, Pennsylvania 19140
    United States

    Active - Recruiting

  • AAPRI Clinical Research Institute

    Warwick, Rhode Island 02886
    United States

    Active - Recruiting

  • Lowcountry Lung and Critical Care, P.A.

    Charleston, South Carolina 29406
    United States

    Active - Recruiting

  • Main Street Physician's Care - Waterway

    Little River, South Carolina 29566
    United States

    Active - Recruiting

  • PMG Research of Charleston, LLC

    Mount Pleasant, South Carolina 29464
    United States

    Active - Recruiting

  • Clinical Research of Rock Hill

    Rock Hill, South Carolina 29732
    United States

    Active - Recruiting

  • Accellacare Bristol

    Bristol, Tennessee 37620
    United States

    Active - Recruiting

  • PMG Research of Knoxville

    Knoxville, Tennessee 37938
    United States

    Active - Recruiting

  • Metroplex Pulmonary and Sleep Center

    Allen, Texas 75013
    United States

    Site Not Available

  • Pharmaceutical Research & Consulting, Inc.

    Dallas, Texas 75231
    United States

    Active - Recruiting

  • Clinical Trial Network LLC

    Houston, Texas 77074
    United States

    Active - Recruiting

  • University of Texas Health Science Center at Houston

    Houston, Texas 77401
    United States

    Active - Recruiting

  • Metroplex Pulmonary and Sleep Center

    McKinney, Texas 75013
    United States

    Active - Recruiting

  • Diagnostics Research Group, LLC

    San Antonio, Texas 78229
    United States

    Active - Recruiting

  • Allergy Asthma Research Institute

    Waco, Texas 76712
    United States

    Active - Recruiting

  • University of Utah Hospitals & Clinics

    Salt Lake City, Utah 84108
    United States

    Site Not Available

  • Eastern Virginia Medical School

    Norfolk, Virginia 23507
    United States

    Active - Recruiting

  • TPMG Clinical Research Williamsburg

    Williamsburg, Virginia 23188
    United States

    Active - Recruiting

  • Bellingham Asthma, Allergy & Immunology Clinic

    Bellingham, Washington 98225
    United States

    Active - Recruiting

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