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

Refractory Chronic Cough Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05600777
• Other study ID #: 221851
• Secondary ID: BUS-P3-02
• Status: Recruiting
• Phase: Phase 3
• Start date: January 13, 2023
• Est. completion date: June 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 24 weeks.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 825
• Est. completion date: June 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
Australia	Royal Adelaide Hospital	Adelaide	South Australia
Australia	Lung Research QLD Pty Ltd	Chermside	Queensland
Australia	The Prince Charles Hospital	Chermside	Queensland
Australia	Northside Health	Coffs Harbour	New South Wales
Australia	Institute for Respiratory Health Inc	Nedlands	Western Australia
Australia	John Hunter Hospital	New Lambton Heights	New South Wales
Australia	TrialsWest	Spearwood	Western Australia
Czechia	MUDr. I. Cierna Peterova s.r.o.	Brandýs Nad Labem
Czechia	Fakultni nemocnice Brno	Brno
Czechia	MUDr. Otakar Hokynar plicni ordinace	Kralupy Nad Vltavou
Czechia	Plicni ambulance - MUDr. Ilona Pavlisova	Miroslav
Czechia	DAWON spol. s.r.o.	Prague
Czechia	MUDr. Jaroslav Mares - TBC a respir. nemoci	Strakonice
Germany	Arztezentrum in der Axel-Springer-Passage	Berlin
Germany	Charité Universitaetsmedizin Berlin - Campus Charité Mitte	Berlin
Germany	Lungenzentrum Darmstadt	Darmstadt	Hessen
Germany	Klinikum der Johann Wolfgang Goethe-Universitaet	Frankfurt	Hessen
Germany	Medaimun GmbH	Frankfurt	Hessen
Germany	Studienzentrum Maingau	Frankfurt am main	Hessen
Germany	Pneumologisches Forschungsinstitut Hohegeest GbR	Geesthacht	Schleswig Holstein
Germany	PRI Pulmonary Research Institute	Großhansdorf	Schleswig Holstein
Germany	Pneumologicum Halle	Halle	Sachsen Anhalt
Germany	Thoraxklinik Heidelberg gGmbH	Heidelberg	Baden Wuerttemberg
Germany	KLB Gesundheitsforschung Luebeck GmbH	Luebeck	Schleswig Holstein
Germany	Zentrum fuer ambulante pneumologische Forschung Marburg GbR	Marburg	Hessen
Germany	Pneumologische Praxis Pasing	Muenchen	Bayern
Germany	Ballenberger Freytag Wenisch Institut für klinische Forschung	Neu Isenburg	Hessen
India	K.L.E. Society's Dr. Prabhakar Kore Hospital and Medical Research Centre	Belgaum	Karnataka
India	Sarvodya Hospital	Faridabad	Haryana
India	Shree Hospital and Critical Care Centre	Nagpur	Maharashtra
India	Assured Care Plus Hospital	Nashik	Maharashtra
India	W. Pratiksha Hospital	Varanasi	Uttar Pradesh
India	Government Hospital for Chest and Communicable Diseases	Visakhapatnam	Andhra Pradesh
Korea, Republic of	Pusan National University Hospital	Busan
Korea, Republic of	The Catholic University of Korea, Incheon St. Mary's Hospital	Incheon
Korea, Republic of	Jeonbuk national university hospital	Jeonju	Jeollabuk-do
Korea, Republic of	Seoul National University Bundang Hospital	Seongnam	Gyeonggi-do
Korea, Republic of	Asan Medical Center	Seoul
Korea, Republic of	Konkuk University Medical Center	Seoul
Korea, Republic of	Korea University Guro Hospital	Seoul
Korea, Republic of	Samsung Medical Center	Seoul
Korea, Republic of	Seoul National University Hospital	Seoul
Korea, Republic of	Severance Hospital, Yonsei University Health System	Seoul
Korea, Republic of	The Catholic University of Korea, Eunpyeong St. Mary's Hospital	Seoul
Korea, Republic of	The Catholic University of Korea, Seoul St. Mary's Hospital	Seoul
Korea, Republic of	Yonsei University Wonju Severance Christian Hospital	Wonju	Gangwon-do
New Zealand	Waitemata Clinical Research	Auckland
New Zealand	Christchurch Hospital NZ	Christchurch
New Zealand	Pacific Clinical Research Network - Forte	Christchurch
New Zealand	Dunedin Hospital	Dunedin
New Zealand	Waikato Hospital	Hamilton
New Zealand	Pacific Clinical Research Network - Rotorua	Rotorua
Slovakia	Alian s.r.o.	Bardejov
Slovakia	Nemocnica s poliklinikou Sv. Jakuba, n.o. Bardejov	Bardejov
Slovakia	Zeleznicna nemocnica s poliklinikou	Košice
Slovakia	PNEUMO-MED s.r.o.	Prievidza
Slovakia	Plucna ambulancia Hrebenar, s.r.o.	Spišská Nová Ves
Taiwan	Changhua Christian Medical Foundation Changhua Christian Hospital	Chang Hua
Taiwan	E-DA Hospital	Kaohsiung
Taiwan	Kaohsiung Medical University Chung-Ho Memorial Hospital	Kaohsiung
Taiwan	Chang Gung Memorial Hospital,Linkou	Taoyuan
United Kingdom	Ormeau Clinical Trials Ltd	Belfast
United Kingdom	Broomfield Hospital	Chelmsford	Essex
United Kingdom	Accellacare Northamptonshire	Corby	Northamptonshire
United Kingdom	Castle Hill Hospital	Cottingham	East Riding Of Yorkshire
United Kingdom	Accellacare Warwickshire	Coventry	West Midlands
United Kingdom	King's College Hospital	Denmark Hill	London
United Kingdom	North Tyneside General Hospital	North Shields	Tyne & Wear
United States	The Iowa Clinic, PC	Ankeny	Iowa
United States	Pharmacorp Clinical Trials, Inc.	Charleston	South Carolina
United States	PMG Research of Charlotte, LLC	Charlotte	North Carolina
United States	Bernstein Clinical Research Center, LLC	Cincinnati	Ohio
United States	Cleveland Clinic	Cleveland	Ohio
United States	Optimed Research, LTD	Columbus	Ohio
United States	Houston Pulmonary, Sleep, Allergy and Asthma Associates	Cypress	Texas
United States	Geisinger Medical Center	Danville	Pennsylvania
United States	Colorado Allergy and Asthma Centers, PC	Denver	Colorado
United States	Minnesota Lung Center	Edina	Minnesota
United States	Clinical Trials Center of Middle Tennessee	Franklin	Tennessee
United States	Clinical Research of Gastonia	Gastonia	North Carolina
United States	G & L Research, LLC	Gulf Shores	Alabama
United States	Clinical Site Partners, LLC d/b/a CSP Leesburg	Leesburg	Florida
United States	California Allergy & Asthma Medical Group Inc.	Los Angeles	California
United States	Southern California Institute For Respiratory Diseases, Inc.	Los Angeles	California
United States	Savin Medical Group LLC	Miami Lakes	Florida
United States	In-Quest Medical Research, LLC	Norcross	Georgia
United States	AMR Norfolk, Formerly Tidewater Associates, an AMR Company	Norfolk	Virginia
United States	Creighton University	Omaha	Nebraska
United States	Phoenix Medical Research Institute, LLC	Peoria	Arizona
United States	ActivMed Practices & Research, LLC	Portsmouth	New Hampshire
United States	Paradigm Clinical Research Centers, Inc.	Redding	California
United States	Mayo Clinic - Rochester	Rochester	Minnesota
United States	The Clinical Research Center, LLC	Saint Louis	Missouri
United States	Quality Assurance Research Center	San Antonio	Texas
United States	Precision Research Institute, LLC	San Diego	California
United States	Allergy & Asthma Associates of Santa Clara Valley	San Jose	California
United States	Destin Pulmonary Critical Care, PLLS.	Santa Rosa Beach	Florida
United States	Lenus Research & Medical Group	Sweetwater	Florida
United States	Accellacare	Winston-Salem	North Carolina
United States	Minnesota Lung Center	Woodbury	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
Bellus Health Inc. - a GSK company

Countries where clinical trial is conducted

United States,  Australia,  Czechia,  Germany,  India,  Korea, Republic of,  New Zealand,  Slovakia,  Taiwan,  United Kingdom, 

Outcome

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