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

Refractory Chronic Cough Clinical Trial

— CALM-1  

Official title:

A Phase 3, 52-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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05599191
• Other study ID #: 221850
• Secondary ID: BUS-P3-01
• Status: Recruiting
• Phase: Phase 3
• Start date: October 25, 2022
• Est. completion date: March 2026

Study information

• Verified date: February 2024
• Source: Bellus Health Inc. - a GSK company
• Contact: US GSK Clinical Trials call Center
• Phone: 877-379-3718
• Email: GSKClinicalSupportHD[@]gsk.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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 information / eligibility

• Status: Recruiting
• Enrollment: 825
• Est. completion date: March 2026
• Est. primary completion date: September 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Cough
• Refractory Chronic Cough

Intervention

Drug:
• BLU-5937
Oral administration of BLU-5937 Tablets
• Placebo
Oral administration of matching placebo for BLU-5937 Tablets

Locations

Country	Name	City	State
Argentina	Expertia S.A- Mautalen Salud e Investigación	Ciudad Autonoma Buenos Aires	Buenos Aires
Argentina	Hospital Italiano de Buenos Aires	Ciudad Autonoma Buenos Aires
Argentina	CINME - Centro De Investigaciones Metabolicas	Ciudad Autonoma de Buenos Aire	Buenos Aires
Argentina	APRILLUS Asistencia e Investigacion	Ciudad Autonoma de Buenos Aires	Ciudad Autonoma Buenos Aires
Argentina	Instituto Medico DAMIC	Cordoba
Argentina	Centro de Investigaciones Medicas Mar del Plata	Mar del Plata	Buenos Aires
Argentina	Fundacion Scherbovsky	Mendoza
Argentina	Insares S.A.	Mendoza
Argentina	Instituto de Especialidades de la Salud Rosario	Rosario	Santa Fe
Argentina	Instituto Medico de la Fundacion Estudios Clinicos	Rosario	Santa Fe
Argentina	Instituto Medico Fundación Grupo Colaborativo Rosario Investigación y Prevención Medica	Rosario	Santa Fe
Argentina	Instituto del Buen Aire	Santa Fe
Argentina	CEMER - Centro Medico de Enfermedades Respiratorias	Vicente López	Buenos Aires
Belgium	Cliniques Universitaires Saint-Luc	Bruxelles
Belgium	Universitair Ziekenhuis Gent	Gent
Belgium	C. H. R. de la Citadelle	Liège
Belgium	AZ Sint-Maarten	Mechelen
Canada	Dynamic Drug Advancement	Ajax	Ontario
Canada	Burlington Lung Clinic	Burlington	Ontario
Canada	Peak Research Group	Calgary	Alberta
Canada	University of Calgary - Health Sciences Centre	Calgary	Alberta
Canada	CISSS de la Monteregie-Centre	Greenfield Park	Quebec
Canada	Hamilton Medical Research Group	Hamilton	Ontario
Canada	McMaster University Health Sciences Center	Hamilton	Ontario
Canada	Kelowna Respirology and Asthma Research	Kelowna	British Columbia
Canada	Montreal Chest Institute	Montréal	Quebec
Canada	Recherche GCP Research	Montréal
Canada	Clinique Specialisee en Allergie de la Capitale	Québec	Quebec
Canada	DIEX Recherche Quebec Inc.	Québec	Quebec
Canada	Institut Universitaire de Cardiologie et de Pneumologie de Quebec	Québec	Quebec
Canada	Clinique de pneumologie et du sommeil de Lanaudière	Saint-Charles-Borromée	Quebec
Canada	Inspiration Research Limited	Toronto	Ontario
Canada	CIC Mauricie Inc.	Trois-Rivières	Quebec
Canada	DIEX Recherche Victoriaville Inc.	Victoriaville	Quebec
Canada	Dr. Syed Anees Medicine Professional Corporation	Windsor	Ontario
Colombia	Fundación Cardiovascular de Colombia - Instituto del Corazón Floridablanca	Floridablanca
Colombia	Asociacion IPS Medicos Internistas de Caldas	Manizales
Colombia	Clinica SOMER	Medellín
Colombia	Fundacion Centro de Investigacion Clinica CIC	Medellín
Colombia	Hospital Pablo Tobón Uribe	Medellín
France	CHU de Dijon - Hôpital François Mitterand	Dijon cedex	Côte-d'Or
France	Hopital Albert Calmette CHU Lille	Lille
France	Hopital Européen de Marseille	Marseille	Bouches-du-Rhône
France	Hôpital Nord - CHU Marseille	Marseille	Bouches-du-Rhône
France	Hopital Arnaud de Villeneuve	Montpellier cedex 5	Herault
France	Hôpital Cochin	Paris
France	CHU de Strasbourg - Nouvel Hôpital Civil	Strasbourg	Bas Rhin
France	Hopital Larrey	Toulouse	Haute Garonne
Hungary	DRC Gyogyszervizsgalo Kozpont Kft.	Balatonfüred
Hungary	Clinexpert Kft.	Budapest
Hungary	Omnimodus Elixir Kft.	Csorna
Hungary	Erzsebet Gondozohaz Kft.	Gödöllo
Hungary	Szalay Janos Rendelointezet	Hajdunanas
Hungary	Da Vinci Maganklinika	Pécs
Hungary	Puspokladanyi Egeszsegugyi Szolgaltato Nonprofit Kft.	Püspökladány
India	Shetty Hospital	Bengaluru	Karnataka
India	Institute of Medical Sciences and SUM Hospital	Bhubaneswar	Orissa
India	Indraprastha Apollo Hospitals	Delhi
India	Asthma Bhavan	Jaipur	Rajasthan
India	Calcutta Medical Research Institute	Kolkata	West Bengal
India	Siddhi Hospital	Nashik	Maharashtra
India	Suyog Multispeciality Hospital	Nashik	Maharashtra
India	ACE Hospital and Research Centre	Pune	Masharashtra
India	Pandit Bhagwat Dayal Sharma Post Graduate Institute of Medical Sciences	Rohtak	Haryana
India	Bhaktivedanta Hospital and Research Institute	Thane	Maharashtra
India	Aashirwad Hospital	Ulhasnagar	Maharashtra
Israel	Hillel Yaffe Medical Center	Hadera
Israel	The Lady Davis Carmel Medical Center	Haifa
Israel	Hadassah University Hospital - Ein Kerem	Jerusalem
Israel	Rabin Medical Center-Beilinson Campus	Petach Tikva
Israel	Sheba Medical Center	Ramat Gan
Israel	Tel Aviv Sourasky Medical Center	Tel Aviv
Netherlands	Noordwest Ziekenhuisgroep	Alkmaar
Netherlands	Rijnstate	Arnhem
Netherlands	Amphia Ziekenhuis, Molengracht	Breda
Netherlands	Bernhoven Uden	Uden
Netherlands	Gelre Ziekenhuizen, Zutphen	Zutphen
Netherlands	Isala Klinieken, Weezenlanden	Zwolle
Poland	Prywatny Gabinet Internistyczno-Alergologiczny	Bialystok
Poland	Centrum Medyczne Pratia Bydgoszcz	Bydgoszcz
Poland	Uniwersytecki Szpital Kliniczny nr 1 im. N. Barlickiego w Lodzi	Lódz
Poland	Uniwersytecki Szpital Kliniczny nr 1 im. Norberta Barlickiego	Lódz
Poland	Ostrowieckie Centrum Medyczne spólka cywilna Anna Olech-Cudzik, Krzysztof Cudzik	Ostrowiec Swietokrzyski
Poland	Center of Innovative Therapies	Piaseczno
Poland	Prywatny Gabinet Lekarski	Rzeszów
Poland	Alergo-Med Specjalistyczna Przychodnia Lekarska Sp. Z .O.O.	Tarnów
Poland	Centrum Medyczne Lucyna Andrzej Dymek s.c.	Zawadzkie
South Africa	Iatros International	Bloemfontein	Free State
South Africa	Dr NK Gounden Medi-Centre	Durban	KwaZulu-Natal
South Africa	TASK Eden	George	Western Cape
South Africa	Smith, C - Morningside Hospital	Johannesburg	Gauteng
South Africa	Worthwhile Clinical Trials	Johannesburg	Gauteng
South Africa	Botho ke Bontle Health Services	Pretoria	Gauteng
South Africa	Global Clinical Trials	Pretoria	Gauteng
South Africa	Dr JM Engelbrecht Trial Site	Somerset West	Western Cape
Spain	Accellacare España SL	Alcobendas	Madrid
Spain	Hospital Clinic de Barcelona	Barcelona
Spain	Hospital de la Santa Creu i Sant Pau	Barcelona
Spain	Hospital General Universitario Gregorio Marañon	Madrid
Spain	Hospital Universitario Clinico San Carlos	Madrid
Spain	Hospital Universitario de La Princesa	Madrid
Spain	Hospital Clinico Universitario Virgen de la Victoria	Málaga
Spain	Hospital Quironsalud Malaga	Málaga
Spain	Hospital Universitario Quironsalud Madrid	Pozuelo De Alarcón	Madrid
Spain	Complejo Hospitalario Universitario de Santiago	Santiago De Compostela	La Coruña
Turkey	Sureyyapasa Pulmonary Diseases and Cardiothoracic Surgery Education and Research Hospital	Istanbul
Turkey	Yedikule Pulmonary Dis. and Surgery Edu. and Res. Hosp.	Istanbul
Turkey	Ege University Medical Faculty	Izmir
Turkey	Kocaeli Universitesi - Kocaeli Universitesi Tip Fakultesi	Izmit
Turkey	Mersin University Medical Faculty	Mersin
Turkey	TC SBU Izmir Dr Suat Seren Gogus Hastaliklari ve Cerrahisi Egitim ve Arastirma	Yenisehir
United Kingdom	Belfast City Hospital	Belfast
United Kingdom	West Walk Surgery	Bristol
United Kingdom	Lakeside Healthcare	Corby	Northamptonshire
United Kingdom	Holderness Health	Hull	East Riding Of Yorkshire
United Kingdom	Royal Brompton Hospital	London	Greater London
United Kingdom	Accellacare North London	Northwood	Middlesex
United Kingdom	Norfolk and Norwich University Hospital	Norwich	Norfolk
United Kingdom	Accellacare South London	Orpington	Kent
United Kingdom	Accellacare Yorkshire	Shipley	Bedfordshire
United Kingdom	Wythenshawe Hospital	Wythenshawe	Greater Manchester
United States	McFarland Clinic P.C.	Ames	Iowa
United States	Michigan Medicine Investigational Drug Services	Ann Arbor	Michigan
United States	Care Access Research	Aurora	Colorado
United States	The Asthma and Allergy Center	Bellevue	Nebraska
United States	Bellingham Asthma, Allergy & Immunology Clinic	Bellingham	Washington
United States	Accellacare Bristol	Bristol	Tennessee
United States	Montefiore Medical Center (MMC)	Bronx	New York
United States	Lowcountry Lung and Critical Care, P.A.	Charleston	South Carolina
United States	American Health Research, Inc.	Charlotte	North Carolina
United States	Innovative Research of West Florida, Inc.	Clearwater	Florida
United States	The Curators of the University of Missouri on behalf of University of Missouri Health Care	Columbia	Missouri
United States	Remington-Davis, Inc.	Columbus	Ohio
United States	Avant Research Associates, LLC	Crowley	Louisiana
United States	Pharmaceutical Research & Consulting, Inc.	Dallas	Texas
United States	Omega Research Consultants	DeBary	Florida
United States	PMG Research of DuPage Medical Group	Downers Grove	Illinois
United States	Clinical Research Associates of Central PA, LLC	DuBois	Pennsylvania
United States	Warren W. Pleskow, MD, 1071572	Encinitas	California
United States	North Florida Foundation for Research and Education, Inc.	Gainesville	Florida
United States	The Community Research of South Florida	Hialeah	Florida
United States	Clinical Trial Network LLC	Houston	Texas
United States	University of Texas Health Science Center at Houston	Houston	Texas
United States	University of Iowa Hospitals & Clinics	Iowa City	Iowa
United States	Jasper Summit Research, LLC	Jasper	Alabama
United States	University of Kansas Medical Center Research Institute, Inc.	Kansas City	Kansas
United States	PMG Research of Knoxville	Knoxville	Tennessee
United States	Sher Allergy	Largo	Florida
United States	Gwinnett Pulmonary Group P.C.	Lawrenceville	Georgia
United States	Research Solutions of Arizona, PC	Litchfield Park	Arizona
United States	Main Street Physician's Care - Waterway	Little River	South Carolina
United States	Little Rock Allergy & Asthma, P.A. Clinical Research Center	Little Rock	Arkansas
United States	Metroplex Pulmonary and Sleep Center	McKinney	Texas
United States	Velocity Clinical Research	Medford	Oregon
United States	Coral Research Clinic corp	Miami	Florida
United States	Cordova Research Institute, LLC	Miami	Florida
United States	Life Spring Research Foundation	Miami	Florida
United States	Well Pharma Medical Research Corporation	Miami	Florida
United States	Allergy & Asthma Research of Southern California	Mission Viejo	California
United States	Montana Medical Research, Inc.	Missoula	Montana
United States	PMG Research of Charleston, LLC	Mount Pleasant	South Carolina
United States	Eastern Virginia Medical School	Norfolk	Virginia
United States	Sneeze, Wheeze and Itch Associates, LLC	Normal	Illinois
United States	Infinity Medical Research Inc	North Dartmouth	Massachusetts
United States	University of Oklahoma Health Sciences Center	Oklahoma City	Oklahoma
United States	Center for Clinical Trials, LLC	Paramount	California
United States	Temple Lung Center	Philadelphia	Pennsylvania
United States	Allergy Associates Research Center	Portland	Oregon
United States	PMG Research of Raleigh	Raleigh	North Carolina
United States	Clinical Research of Rock Hill	Rock Hill	South Carolina
United States	PMG Research of Rocky Mount, LLC	Rocky Mount	North Carolina
United States	PMG Research of Salisbury, LLC	Salisbury	North Carolina
United States	University of Utah Hospitals & Clinics	Salt Lake City	Utah
United States	Diagnostics Research Group, LLC	San Antonio	Texas
United States	Allergy Associates Medical Group, Inc.	San Diego	California
United States	Medical Research of Arizona	Scottsdale	Arizona
United States	Cotton O'Neil Clinical Research Center	Topeka	Kansas
United States	Vital Prospects Clinical Research Institute, P.C.	Tulsa	Oklahoma
United States	Allergy Asthma Research Institute	Waco	Texas
United States	AAPRI Clinical Research Institute	Warwick	Rhode Island
United States	University of Kansas Medical Center Research Institute, Inc.	Wichita	Kansas
United States	TPMG Clinical Research Williamsburg	Williamsburg	Virginia
United States	Southeastern Research Center LLC	Winston-Salem	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Bellus Health Inc. - a GSK company

Countries where clinical trial is conducted

United States,  Argentina,  Belgium,  Canada,  Colombia,  France,  Hungary,  India,  Israel,  Netherlands,  Poland,  South Africa,  Spain,  Turkey,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	24-Hour Cough Frequency	Assessed using an ambulatory cough monitor	Week 12
Secondary	Change from Baseline in Cough Severity Visual Analogue Scale at 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.	Baseline, Week 12
Secondary	Percentage of Participants With = 30mm Reduction, = 20mm Reduction From Baseline in Cough Severity Visual Analog Scale (VAS) at 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.	Baseline, Week 12
Secondary	Percentage of Participants With =30%, =50%, and =70% Reduction From Baseline in 24-Hour Cough Frequency at Week 12	Assessed using an ambulatory cough monitor	Baseline, Week 12
Secondary	Change from Baseline in the Leicester Cough Questionnaire (LCQ) Total Score at 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.	Baseline, Week 12
Secondary	Percentage of Participants With a =1.3-point Increase From Baseline in Leicester Cough Questionnaire (LCQ) Total Score at 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.	Baseline, Week 12