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

February 14, 2024 updated by: Bellus Health Inc. - a GSK company

A Phase 3, 24-Week, Randomized, Double-Blind, Placebo-Controlled, Parallel-Arm Efficacy and Safety Study With Open-Label Extension of BLU-5937 in Adult Participants With Refractory Chronic Cough, Including Unexplained Chronic Cough

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 24 weeks.

Study Type

Interventional

Enrollment (Estimated)

825

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Australia
    • New South Wales
      • Coffs Harbour, New South Wales, Australia, 2450
        • Recruiting
        • Northside Health
      • New Lambton Heights, New South Wales, Australia, 2305
        • Not yet recruiting
        • John Hunter Hospital
    • Queensland
      • Chermside, Queensland, Australia, 4032
        • Recruiting
        • The Prince Charles Hospital
      • Chermside, Queensland, Australia, 4032
        • Recruiting
        • Lung Research QLD Pty Ltd
    • South Australia
      • Adelaide, South Australia, Australia, 5000
        • Recruiting
        • Royal Adelaide Hospital
    • Western Australia
      • Nedlands, Western Australia, Australia, 6009
        • Recruiting
        • Institute for Respiratory Health Inc
      • Spearwood, Western Australia, Australia, 6163
        • Recruiting
        • Trialswest
  • Czechia
      • Brandýs Nad Labem, Czechia, 25001
        • Recruiting
        • MUDr. I. Cierna Peterova s.r.o.
      • Brno, Czechia, 62500
        • Recruiting
        • Fakultni nemocnice Brno
      • Kralupy Nad Vltavou, Czechia, 278 01
        • Recruiting
        • MUDr. Otakar Hokynar plicni ordinace
      • Miroslav, Czechia, 671 72
        • Recruiting
        • Plicni ambulance - MUDr. Ilona Pavlisova
      • Prague, Czechia, 14800
        • Recruiting
        • DAWON spol. s.r.o.
      • Strakonice, Czechia, 386 01
        • Recruiting
        • MUDr. Jaroslav Mares - TBC a respir. nemoci
  • Germany
      • Berlin, Germany, 10117
        • Withdrawn
        • Charite Universitaetsmedizin Berlin - Campus Charite Mitte
      • Berlin, Germany, 10969
        • Recruiting
        • Arztezentrum in der Axel-Springer-Passage
    • Baden Wuerttemberg
      • Heidelberg, Baden Wuerttemberg, Germany, 69126
        • Recruiting
        • Thoraxklinik Heidelberg gGmbH
    • Bayern
      • Muenchen, Bayern, Germany, 81241
        • Recruiting
        • Pneumologische Praxis Pasing
    • Hessen
      • Darmstadt, Hessen, Germany, 64283
        • Recruiting
        • Lungenzentrum Darmstadt
      • Frankfurt, Hessen, Germany, 60590
        • Recruiting
        • Klinikum der Johann Wolfgang Goethe-Universitaet
      • Frankfurt, Hessen, Germany, 60596
        • Recruiting
        • Medaimun GmbH
      • Frankfurt am main, Hessen, Germany, 60315
        • Recruiting
        • Studienzentrum Maingau
      • Marburg, Hessen, Germany, 35037
        • Recruiting
        • Zentrum fuer ambulante pneumologische Forschung Marburg GbR
      • Neu Isenburg, Hessen, Germany, 63263
        • Recruiting
        • Ballenberger Freytag Wenisch Institut für klinische Forschung
    • Sachsen Anhalt
      • Halle, Sachsen Anhalt, Germany, 06108
        • Recruiting
        • Pneumologicum Halle
    • Schleswig Holstein
      • Geesthacht, Schleswig Holstein, Germany, 21502
        • Recruiting
        • Pneumologisches Forschungsinstitut Hohegeest GbR
      • Großhansdorf, Schleswig Holstein, Germany, 22927
        • Withdrawn
        • PRI Pulmonary Research Institute
      • Luebeck, Schleswig Holstein, Germany, 23552
        • Recruiting
        • KLB Gesundheitsforschung Luebeck GmbH
  • India
    • Andhra Pradesh
      • Visakhapatnam, Andhra Pradesh, India, 530017
        • Not yet recruiting
        • Government Hospital for Chest and Communicable Diseases
    • Haryana
      • Faridabad, Haryana, India, 121006
        • Not yet recruiting
        • Sarvodya Hospital
    • Karnataka
      • Belgaum, Karnataka, India, 590010
        • Not yet recruiting
        • K.L.E. Society's Dr. Prabhakar Kore Hospital and Medical Research Centre
    • Maharashtra
      • Nagpur, Maharashtra, India, 440009
        • Not yet recruiting
        • Shree Hospital And Critical Care Centre
      • Nashik, Maharashtra, India, 422001
        • Not yet recruiting
        • Assured Care Plus Hospital
    • Uttar Pradesh
      • Varanasi, Uttar Pradesh, India, 221005
        • Not yet recruiting
        • W. Pratiksha Hospital
  • Korea, Republic of
      • Busan, Korea, Republic of, 49241
        • Recruiting
        • Pusan National University Hospital
      • Incheon, Korea, Republic of, 21431
        • Recruiting
        • The Catholic University of Korea, Incheon St. Mary's Hospital
      • Seoul, Korea, Republic of, 08308
        • Recruiting
        • Korea University Guro Hospital
      • Seoul, Korea, Republic of, 03080
        • Recruiting
        • Seoul National University Hospital
      • Seoul, Korea, Republic of, 05505
        • Recruiting
        • Asan Medical Center
      • Seoul, Korea, Republic of, 06351
        • Recruiting
        • Samsung Medical Center
      • Seoul, Korea, Republic of, 06591
        • Recruiting
        • The Catholic University of Korea, Seoul St. Mary's Hospital
      • Seoul, Korea, Republic of, 03722
        • Recruiting
        • Severance Hospital, Yonsei University Health System
      • Seoul, Korea, Republic of, 03312
        • Recruiting
        • The Catholic University of Korea, Eunpyeong St. Mary's Hospital
      • Seoul, Korea, Republic of, 05030
        • Recruiting
        • Konkuk University Medical Center
    • Gangwon-do
      • Wŏnju, Gangwon-do, Korea, Republic of, 26426
        • Recruiting
        • Yonsei University Wonju Severance Christian Hospital
    • Gyeonggi-do
      • Seongnam, Gyeonggi-do, Korea, Republic of, 13620
        • Recruiting
        • Seoul National University Bundang Hospital
    • Jeollabuk-do
      • Jeonju, Jeollabuk-do, Korea, Republic of, 54907
        • Recruiting
        • Jeonbuk National University Hospital
  • New Zealand
      • Auckland, New Zealand, 0626
        • Recruiting
        • Waitemata Clinical Research
      • Christchurch, New Zealand, 8011
        • Recruiting
        • Christchurch Hospital NZ
      • Christchurch, New Zealand, 8013
        • Recruiting
        • Pacific Clinical Research Network - Forte
      • Dunedin, New Zealand, 9016
        • Recruiting
        • Dunedin Hospital
      • Hamilton, New Zealand, 3200
        • Recruiting
        • Waikato Hospital
      • Rotorua, New Zealand, 3010
        • Recruiting
        • Pacific Clinical Research Network - Rotorua
  • Slovakia
      • Bardejov, Slovakia, 08501
        • Recruiting
        • ALIAN s.r.o.
      • Bardejov, Slovakia, 08501
        • Recruiting
        • Nemocnica s poliklinikou Sv. Jakuba, n.o. Bardejov
      • Košice, Slovakia, 04001
        • Recruiting
        • Zeleznicna nemocnica s poliklinikou
      • Prievidza, Slovakia, 97101
        • Recruiting
        • PNEUMO-MED s.r.o.
      • Spišská Nová Ves, Slovakia, 05201
        • Recruiting
        • Plucna ambulancia Hrebenar, s.r.o.
  • Taiwan
      • Chang Hua, Taiwan, 50006
        • Recruiting
        • Changhua Christian Medical Foundation Changhua Christian Hospital
      • Kaohsiung, Taiwan, 807
        • Recruiting
        • Kaohsiung Medical University Chung-Ho Memorial Hospital
      • Kaohsiung, Taiwan, 82445
        • Recruiting
        • E-DA Hospital
      • Taoyuan, Taiwan, 333
        • Recruiting
        • Chang Gung Memorial Hospital,Linkou
  • United Kingdom
      • Belfast, United Kingdom, BT7 2EB
        • Recruiting
        • Ormeau Clinical Trials Ltd
    • East Riding Of Yorkshire
      • Cottingham, East Riding Of Yorkshire, United Kingdom, HU16 5JQ
        • Recruiting
        • Castle Hill Hospital
    • Essex
      • Chelmsford, Essex, United Kingdom, CM1 7ET
        • Recruiting
        • Broomfield Hospital
    • London
      • Denmark Hill, London, United Kingdom, SE5 9R2
        • Recruiting
        • King's College Hospital
    • Northamptonshire
      • Corby, Northamptonshire, United Kingdom, NN18 9EZ
        • Recruiting
        • Accellacare Northamptonshire
    • Tyne & Wear
      • North Shields, Tyne & Wear, United Kingdom, NE29 8NH
        • Recruiting
        • North Tyneside General Hospital
    • West Midlands
      • Coventry, West Midlands, United Kingdom, CV3 4FJ
        • Recruiting
        • Accellacare Warwickshire
  • United States
    • Alabama
      • Gulf Shores, Alabama, United States, 36547
        • Recruiting
        • G & L Research, LLC
    • Arizona
      • Peoria, Arizona, United States, 85381
        • Withdrawn
        • Phoenix Medical Research Institute, LLC
    • California
      • Los Angeles, California, United States, 90025
        • Recruiting
        • California Allergy & Asthma Medical Group Inc.
      • Los Angeles, California, United States, 90048
        • Recruiting
        • Southern California Institute For Respiratory Diseases, Inc.
      • Redding, California, United States, 96001
        • Recruiting
        • Paradigm Clinical Research Centers, Inc.
      • San Diego, California, United States, 92114
        • Recruiting
        • Precision Research Institute, LLC
      • San Jose, California, United States, 95117
        • Recruiting
        • Allergy & Asthma Associates of Santa Clara Valley
    • Colorado
      • Denver, Colorado, United States, 80230
        • Recruiting
        • Colorado Allergy and Asthma Centers, PC
    • Florida
      • Leesburg, Florida, United States, 34748
        • Recruiting
        • Clinical Site Partners, LLC d/b/a CSP Leesburg
      • Miami Lakes, Florida, United States, 33014
        • Recruiting
        • Savin Medical Group LLC
      • Santa Rosa Beach, Florida, United States, 32459
        • Recruiting
        • Destin Pulmonary Critical Care, PLLS.
      • Sweetwater, Florida, United States, 33172
        • Recruiting
        • Lenus Research & Medical Group
    • Georgia
      • Norcross, Georgia, United States, 30071
        • Recruiting
        • In-Quest Medical Research, LLC
    • Iowa
      • Ankeny, Iowa, United States, 50023
        • Recruiting
        • The Iowa Clinic, PC
    • Minnesota
      • Edina, Minnesota, United States, 55435
        • Recruiting
        • Minnesota Lung Center
      • Rochester, Minnesota, United States, 55905
        • Recruiting
        • Mayo Clinic - Rochester
      • Woodbury, Minnesota, United States, 55125
        • Recruiting
        • Minnesota Lung Center
    • Missouri
      • Saint Louis, Missouri, United States, 63141
        • Recruiting
        • The Clinical Research Center, LLC
    • Nebraska
      • Omaha, Nebraska, United States, 68124
        • Recruiting
        • Creighton University
    • New Hampshire
      • Portsmouth, New Hampshire, United States, 03801
        • Recruiting
        • ActivMed Practices & Research, LLC
    • North Carolina
      • Charlotte, North Carolina, United States, 28209
        • Recruiting
        • PMG Research of Charlotte, LLC
      • Gastonia, North Carolina, United States, 28054
        • Recruiting
        • Clinical Research of Gastonia
      • Winston-Salem, North Carolina, United States, 27103
        • Recruiting
        • Accellacare
    • Ohio
      • Cincinnati, Ohio, United States, 45236
        • Withdrawn
        • Bernstein Clinical Research Center, LLC
      • Cleveland, Ohio, United States, 44195
        • Not yet recruiting
        • Cleveland Clinic
      • Columbus, Ohio, United States, 43235
        • Recruiting
        • Optimed Research, LTD
    • Pennsylvania
      • Danville, Pennsylvania, United States, 17822
        • Not yet recruiting
        • Geisinger Medical Center
    • South Carolina
      • Charleston, South Carolina, United States, 29412
        • Recruiting
        • Pharmacorp Clinical Trials, Inc.
    • Tennessee
      • Franklin, Tennessee, United States, 37067
        • Recruiting
        • Clinical Trials Center of Middle Tennessee
    • Texas
      • Cypress, Texas, United States, 77429
        • Recruiting
        • Houston Pulmonary, Sleep, Allergy and Asthma Associates
      • San Antonio, Texas, United States, 78207
        • Recruiting
        • Quality Assurance Research Center
    • Virginia
      • Norfolk, Virginia, United States, 23507
        • Recruiting
        • AMR Norfolk, Formerly Tidewater Associates, an AMR Company

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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 method during the study and for at least 14 days after the last dose

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 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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: BLU-5937 25 mg
BLU-5937 oral dose 25 mg twice a day.
Drug: BLU-5937
Oral administration of BLU-5937 Tablets
Experimental: BLU-5937 50 mg
BLU-5937 oral dose 50 mg twice a day.
Drug: BLU-5937
Oral administration of BLU-5937 Tablets
Placebo Comparator: Placebo
Matching Placebo for BLU-5937 oral dose twice a day.
Drug: Placebo
Oral administration of matching placebo for BLU-5937 Tablets

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
24-Hour Cough Frequency
Time Frame: Week 24
Assessed using an ambulatory cough monitor
Week 24

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from Baseline in Cough Severity Visual Analogue Scale at Week 24
Time Frame: Baseline, Week 24
Assessed by Cough Severity Visual Analogue Scale [VAS] by the participant on a 100 mm visual analog scale where higher scores indicate greater severity.
Baseline, Week 24
Percentage of Participants With ≥ 30mm Reduction, ≥ 20mm Reduction From Baseline in Cough Severity Visual Analog Scale (VAS) at Week 24
Time Frame: Baseline, Week 24
Assessed by Cough Severity Visual Analogue Scale [VAS] by the participant on a 100 mm visual analog scale where higher scores indicate greater severity.
Baseline, Week 24
Percentage of Participants With ≥30%, ≥50%, and ≥70% Reduction From Baseline in 24-Hour Cough Frequency at Week 24
Time Frame: Baseline, Week 24
Assessed using an ambulatory cough monitor
Baseline, Week 24
Change from Baseline in the Leicester Cough Questionnaire (LCQ) Total Score at Week 24
Time Frame: Baseline, Week 24
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.
Baseline, Week 24
Percentage of Participants With a ≥1.3-point Increase From Baseline in Leicester Cough Questionnaire (LCQ) Total Score at Week 24
Time Frame: Baseline, Week 24
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.
Baseline, Week 24

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bellus Health Inc. - a GSK company

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 13, 2023

Primary Completion (Estimated)

September 1, 2025

Study Completion (Estimated)

June 1, 2026

Study Registration Dates

First Submitted

October 18, 2022

First Submitted That Met QC Criteria

October 25, 2022

First Posted (Actual)

October 31, 2022

Study Record Updates

Last Update Posted (Actual)

February 15, 2024

Last Update Submitted That Met QC Criteria

February 14, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 221851
  • BUS-P3-02 (Other Identifier: Bellus Health Inc)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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