A 24-Week Study of the Efficacy and Safety of BLU-5937 in Adults With Refractory Chronic Cough (CALM-2)

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

Phase

3

Condition

N/A

Treatment

BLU-5937

Placebo

Clinical Study ID

NCT05600777
221851
BUS-P3-02
  • 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: BLU-5937
Phase: 3
Study Start date:
January 13, 2023
Estimated Completion Date:
June 30, 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 24 weeks.

Connect with a study center

  • Northside Health

    Coffs Harbour, New South Wales 2450
    Australia

    Active - Recruiting

  • John Hunter Hospital

    New Lambton Heights, New South Wales 2305
    Australia

    Site Not Available

  • Lung Research QLD Pty Ltd

    Chermside, Queensland 4032
    Australia

    Active - Recruiting

  • The Prince Charles Hospital

    Chermside, Queensland 4032
    Australia

    Active - Recruiting

  • Royal Adelaide Hospital

    Adelaide, South Australia 5000
    Australia

    Active - Recruiting

  • Institute for Respiratory Health Inc

    Nedlands, Western Australia 6009
    Australia

    Active - Recruiting

  • TrialsWest

    Spearwood, Western Australia 6163
    Australia

    Active - Recruiting

  • MUDr. I. Cierna Peterova s.r.o.

    Brandýs Nad Labem, 25001
    Czechia

    Active - Recruiting

  • Fakultni nemocnice Brno

    Brno, 62500
    Czechia

    Active - Recruiting

  • MUDr. Otakar Hokynar plicni ordinace

    Kralupy Nad Vltavou, 278 01
    Czechia

    Active - Recruiting

  • Plicni ambulance - MUDr. Ilona Pavlisova

    Miroslav, 671 72
    Czechia

    Active - Recruiting

  • DAWON spol. s.r.o.

    Prague, 14800
    Czechia

    Active - Recruiting

  • MUDr. Jaroslav Mares - TBC a respir. nemoci

    Strakonice, 386 01
    Czechia

    Active - Recruiting

  • Thoraxklinik Heidelberg gGmbH

    Heidelberg, Baden Wuerttemberg 69126
    Germany

    Active - Recruiting

  • Pneumologische Praxis Pasing

    Muenchen, Bayern 81241
    Germany

    Active - Recruiting

  • Lungenzentrum Darmstadt

    Darmstadt, Hessen 64283
    Germany

    Active - Recruiting

  • Klinikum der Johann Wolfgang Goethe-Universitaet

    Frankfurt, Hessen 60590
    Germany

    Active - Recruiting

  • Medaimun GmbH

    Frankfurt, Hessen 60596
    Germany

    Active - Recruiting

  • Studienzentrum Maingau

    Frankfurt am main, Hessen 60315
    Germany

    Active - Recruiting

  • Zentrum fuer ambulante pneumologische Forschung Marburg GbR

    Marburg, Hessen 35037
    Germany

    Active - Recruiting

  • Ballenberger Freytag Wenisch Institut für klinische Forschung

    Neu Isenburg, Hessen 63263
    Germany

    Active - Recruiting

  • Pneumologicum Halle

    Halle, Sachsen Anhalt 06108
    Germany

    Active - Recruiting

  • Pneumologisches Forschungsinstitut Hohegeest GbR

    Geesthacht, Schleswig Holstein 21502
    Germany

    Active - Recruiting

  • PRI Pulmonary Research Institute

    Großhansdorf, Schleswig Holstein 22927
    Germany

    Site Not Available

  • KLB Gesundheitsforschung Luebeck GmbH

    Luebeck, Schleswig Holstein 23552
    Germany

    Active - Recruiting

  • Arztezentrum in der Axel-Springer-Passage

    Berlin, 10969
    Germany

    Active - Recruiting

  • Charité Universitaetsmedizin Berlin - Campus Charité Mitte

    Berlin, 10117
    Germany

    Site Not Available

  • Government Hospital for Chest and Communicable Diseases

    Visakhapatnam, Andhra Pradesh 530017
    India

    Site Not Available

  • Sarvodya Hospital

    Faridabad, Haryana 121006
    India

    Site Not Available

  • K.L.E. Society's Dr. Prabhakar Kore Hospital and Medical Research Centre

    Belgaum, Karnataka 590010
    India

    Site Not Available

  • Shree Hospital and Critical Care Centre

    Nagpur, Maharashtra 440009
    India

    Site Not Available

  • Assured Care Plus Hospital

    Nashik, Maharashtra 422001
    India

    Site Not Available

  • W. Pratiksha Hospital

    Varanasi, Uttar Pradesh 221005
    India

    Site Not Available

  • Yonsei University Wonju Severance Christian Hospital

    Wŏnju, Gangwon-do 26426
    Korea, Republic of

    Active - Recruiting

  • Seoul National University Bundang Hospital

    Seongnam, Gyeonggi-do 13620
    Korea, Republic of

    Active - Recruiting

  • Jeonbuk national university hospital

    Jeonju, Jeollabuk-do 54907
    Korea, Republic of

    Active - Recruiting

  • Pusan National University Hospital

    Busan, 49241
    Korea, Republic of

    Active - Recruiting

  • The Catholic University of Korea, Incheon St. Mary's Hospital

    Incheon, 21431
    Korea, Republic of

    Active - Recruiting

  • Asan Medical Center

    Seoul, 05505
    Korea, Republic of

    Active - Recruiting

  • Konkuk University Medical Center

    Seoul, 05030
    Korea, Republic of

    Active - Recruiting

  • Korea University Guro Hospital

    Seoul, 08308
    Korea, Republic of

    Active - Recruiting

  • Samsung Medical Center

    Seoul, 06351
    Korea, Republic of

    Active - Recruiting

  • Seoul National University Hospital

    Seoul, 03080
    Korea, Republic of

    Active - Recruiting

  • Severance Hospital, Yonsei University Health System

    Seoul, 03722
    Korea, Republic of

    Active - Recruiting

  • The Catholic University of Korea, Eunpyeong St. Mary's Hospital

    Seoul, 03312
    Korea, Republic of

    Active - Recruiting

  • The Catholic University of Korea, Seoul St. Mary's Hospital

    Seoul, 06591
    Korea, Republic of

    Active - Recruiting

  • Waitemata Clinical Research

    Auckland, 0626
    New Zealand

    Active - Recruiting

  • Christchurch Hospital NZ

    Christchurch, 8011
    New Zealand

    Active - Recruiting

  • Pacific Clinical Research Network - Forte

    Christchurch, 8013
    New Zealand

    Active - Recruiting

  • Dunedin Hospital

    Dunedin, 9016
    New Zealand

    Active - Recruiting

  • Waikato Hospital

    Hamilton, 3200
    New Zealand

    Active - Recruiting

  • Pacific Clinical Research Network - Rotorua

    Rotorua, 3010
    New Zealand

    Active - Recruiting

  • Alian s.r.o.

    Bardejov, 08501
    Slovakia

    Active - Recruiting

  • Nemocnica s poliklinikou Sv. Jakuba, n.o. Bardejov

    Bardejov, 08501
    Slovakia

    Active - Recruiting

  • Zeleznicna nemocnica s poliklinikou

    Košice, 04001
    Slovakia

    Active - Recruiting

  • PNEUMO-MED s.r.o.

    Prievidza, 97101
    Slovakia

    Active - Recruiting

  • Plucna ambulancia Hrebenar, s.r.o.

    Spišská Nová Ves, 05201
    Slovakia

    Active - Recruiting

  • Changhua Christian Medical Foundation Changhua Christian Hospital

    Chang Hua, 50006
    Taiwan

    Active - Recruiting

  • E-DA Hospital

    Kaohsiung, 82445
    Taiwan

    Active - Recruiting

  • Kaohsiung Medical University Chung-Ho Memorial Hospital

    Kaohsiung, 807
    Taiwan

    Active - Recruiting

  • Chang Gung Memorial Hospital,Linkou

    Taoyuan, 333
    Taiwan

    Active - Recruiting

  • Castle Hill Hospital

    Cottingham, East Riding Of Yorkshire HU16 5JQ
    United Kingdom

    Active - Recruiting

  • Broomfield Hospital

    Chelmsford, Essex CM1 7ET
    United Kingdom

    Active - Recruiting

  • King's College Hospital

    Denmark Hill, London SE5 9R2
    United Kingdom

    Active - Recruiting

  • Accellacare Northamptonshire

    Corby, Northamptonshire NN18 9EZ
    United Kingdom

    Active - Recruiting

  • North Tyneside General Hospital

    North Shields, Tyne & Wear NE29 8NH
    United Kingdom

    Active - Recruiting

  • Accellacare Warwickshire

    Coventry, West Midlands CV3 4FJ
    United Kingdom

    Active - Recruiting

  • Ormeau Clinical Trials Ltd

    Belfast, BT7 2EB
    United Kingdom

    Active - Recruiting

  • G & L Research, LLC

    Gulf Shores, Alabama 36547
    United States

    Active - Recruiting

  • Phoenix Medical Research Institute, LLC

    Peoria, Arizona 85381
    United States

    Site Not Available

  • California Allergy & Asthma Medical Group Inc.

    Los Angeles, California 90025
    United States

    Active - Recruiting

  • Southern California Institute For Respiratory Diseases, Inc.

    Los Angeles, California 90048
    United States

    Active - Recruiting

  • Paradigm Clinical Research Centers, Inc.

    Redding, California 96001
    United States

    Active - Recruiting

  • Precision Research Institute, LLC

    San Diego, California 92114
    United States

    Active - Recruiting

  • Allergy & Asthma Associates of Santa Clara Valley

    San Jose, California 95117
    United States

    Active - Recruiting

  • Colorado Allergy and Asthma Centers, PC

    Denver, Colorado 80230
    United States

    Active - Recruiting

  • Clinical Site Partners, LLC d/b/a CSP Leesburg

    Leesburg, Florida 34748
    United States

    Active - Recruiting

  • Savin Medical Group LLC

    Miami Lakes, Florida 33014
    United States

    Active - Recruiting

  • Destin Pulmonary Critical Care, PLLS.

    Santa Rosa Beach, Florida 32459
    United States

    Active - Recruiting

  • Lenus Research & Medical Group

    Sweetwater, Florida 33172
    United States

    Active - Recruiting

  • In-Quest Medical Research, LLC

    Norcross, Georgia 30071
    United States

    Active - Recruiting

  • The Iowa Clinic, PC

    Ankeny, Iowa 50023
    United States

    Active - Recruiting

  • Minnesota Lung Center

    Edina, Minnesota 55435
    United States

    Active - Recruiting

  • Mayo Clinic - Rochester

    Rochester, Minnesota 55905
    United States

    Active - Recruiting

  • Minnesota Lung Center

    Woodbury, Minnesota 55125
    United States

    Active - Recruiting

  • The Clinical Research Center, LLC

    Saint Louis, Missouri 63141
    United States

    Active - Recruiting

  • Creighton University

    Omaha, Nebraska 68124
    United States

    Active - Recruiting

  • ActivMed Practices & Research, LLC

    Portsmouth, New Hampshire 03801
    United States

    Active - Recruiting

  • PMG Research of Charlotte, LLC

    Charlotte, North Carolina 28209
    United States

    Active - Recruiting

  • Clinical Research of Gastonia

    Gastonia, North Carolina 28054
    United States

    Active - Recruiting

  • Accellacare

    Winston-Salem, North Carolina 27103
    United States

    Active - Recruiting

  • Bernstein Clinical Research Center, LLC

    Cincinnati, Ohio 45236
    United States

    Site Not Available

  • Cleveland Clinic

    Cleveland, Ohio 44195
    United States

    Site Not Available

  • Optimed Research, LTD

    Columbus, Ohio 43235
    United States

    Active - Recruiting

  • Geisinger Medical Center

    Danville, Pennsylvania 17822
    United States

    Site Not Available

  • Pharmacorp Clinical Trials, Inc.

    Charleston, South Carolina 29412
    United States

    Active - Recruiting

  • Clinical Trials Center of Middle Tennessee

    Franklin, Tennessee 37067
    United States

    Active - Recruiting

  • Houston Pulmonary, Sleep, Allergy and Asthma Associates

    Cypress, Texas 77429
    United States

    Active - Recruiting

  • Quality Assurance Research Center

    San Antonio, Texas 78207
    United States

    Active - Recruiting

  • AMR Norfolk, Formerly Tidewater Associates, an AMR Company

    Norfolk, Virginia 23507
    United States

    Active - Recruiting

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