A 24-Week Study of the Efficacy and Safety of BLU-5937 in Adults With Refractory Chronic Cough (CALM-2)
- Registration Number
- NCT05600777
- Lead Sponsor
- Bellus Health Inc. - a GSK company
- Brief Summary
This is a randomized, double-blind, placebo-controlled, parallel-arm, Phase 3 study of BLU-5937 in participants with Refractory Chronic Cough (RCC).
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 825
- 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
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description BLU-5937 25 mg BLU-5937 BLU-5937 oral dose 25 mg twice a day. BLU-5937 50 mg BLU-5937 BLU-5937 oral dose 50 mg twice a day. Placebo Placebo Matching Placebo for BLU-5937 oral dose twice a day.
- Primary Outcome Measures
Name Time Method 24-Hour Cough Frequency Week 24 Assessed using an ambulatory cough monitor
- Secondary Outcome Measures
Name Time Method Change from Baseline in Cough Severity Visual Analogue Scale at Week 24 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.
Percentage of Participants With ≥ 30mm Reduction, ≥ 20mm Reduction From Baseline in Cough Severity Visual Analog Scale (VAS) at Week 24 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.
Percentage of Participants With ≥30%, ≥50%, and ≥70% Reduction From Baseline in 24-Hour Cough Frequency at Week 24 Baseline, Week 24 Assessed using an ambulatory cough monitor
Change from Baseline in the Leicester Cough Questionnaire (LCQ) Total Score at Week 24 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.
Percentage of Participants With a ≥1.3-point Increase From Baseline in Leicester Cough Questionnaire (LCQ) Total Score at Week 24 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.
Trial Locations
- Locations (99)
Government Hospital for Chest and Communicable Diseases
🇮🇳Visakhapatnam, Andhra Pradesh, India
In-Quest Medical Research, LLC
🇺🇸Norcross, Georgia, United States
Geisinger Medical Center
🇺🇸Danville, Pennsylvania, United States
Cleveland Clinic
🇺🇸Cleveland, Ohio, United States
Broomfield Hospital
🇬🇧Chelmsford, Essex, United Kingdom
Colorado Allergy and Asthma Centers, PC
🇺🇸Denver, Colorado, United States
Bernstein Clinical Research Center, LLC
🇺🇸Cincinnati, Ohio, 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
Precision Research Institute, LLC
🇺🇸San Diego, California, United States
Minnesota Lung Center
🇺🇸Woodbury, Minnesota, United States
ActivMed Practices & Research, LLC
🇺🇸Portsmouth, New Hampshire, United States
Clinical Site Partners, LLC d/b/a CSP Leesburg
🇺🇸Leesburg, Florida, United States
The Iowa Clinic, PC
🇺🇸Ankeny, Iowa, United States
The Clinical Research Center, LLC
🇺🇸Saint Louis, Missouri, United States
Savin Medical Group LLC
🇺🇸Miami Lakes, Florida, United States
Lenus Research & Medical Group
🇺🇸Sweetwater, Florida, United States
Destin Pulmonary Critical Care, PLLS.
🇺🇸Santa Rosa Beach, Florida, United States
Optimed Research, LTD
🇺🇸Columbus, Ohio, United States
Clinical Trials Center of Middle Tennessee
🇺🇸Franklin, Tennessee, United States
Quality Assurance Research Center
🇺🇸San Antonio, Texas, United States
TrialsWest
🇦🇺Spearwood, Western Australia, Australia
Institute for Respiratory Health Inc
🇦🇺Nedlands, Western Australia, Australia
MUDr. I. Cierna Peterova s.r.o.
🇨🇿Brandýs Nad Labem, Czechia
Royal Adelaide Hospital
🇦🇺Adelaide, South Australia, Australia
Fakultni nemocnice Brno
🇨🇿Brno, Czechia
Zentrum fuer ambulante pneumologische Forschung Marburg GbR
🇩🇪Marburg, Hessen, Germany
Ballenberger Freytag Wenisch Institut für klinische Forschung
🇩🇪Neu Isenburg, Hessen, Germany
Christchurch Hospital NZ
🇳🇿Christchurch, New Zealand
Korea University Guro Hospital
🇰🇷Seoul, Korea, Republic of
PRI Pulmonary Research Institute
🇩🇪Großhansdorf, Schleswig Holstein, Germany
Pneumologicum Halle
🇩🇪Halle, Sachsen Anhalt, Germany
Waitemata Clinical Research
🇳🇿Auckland, New Zealand
Sarvodya Hospital
🇮🇳Faridabad, Haryana, India
K.L.E. Society's Dr. Prabhakar Kore Hospital and Medical Research Centre
🇮🇳Belgaum, Karnataka, India
Shree Hospital and Critical Care Centre
🇮🇳Nagpur, Maharashtra, India
Yonsei University Wonju Severance Christian Hospital
🇰🇷Wŏnju, Gangwon-do, Korea, Republic of
Konkuk University Medical Center
🇰🇷Seoul, Korea, Republic of
The Catholic University of Korea, Eunpyeong St. Mary's Hospital
🇰🇷Seoul, Korea, Republic of
Severance Hospital, Yonsei University Health System
🇰🇷Seoul, Korea, Republic of
The Catholic University of Korea, Incheon St. Mary's Hospital
🇰🇷Incheon, Korea, Republic of
Alian s.r.o.
🇸🇰Bardejov, Slovakia
Dunedin Hospital
🇳🇿Dunedin, New Zealand
Pacific Clinical Research Network - Rotorua
🇳🇿Rotorua, New Zealand
Nemocnica s poliklinikou Sv. Jakuba, n.o. Bardejov
🇸🇰Bardejov, Slovakia
Plucna ambulancia Hrebenar, s.r.o.
🇸🇰Spišská Nová Ves, Slovakia
Accellacare Northamptonshire
🇬🇧Corby, Northamptonshire, United Kingdom
North Tyneside General Hospital
🇬🇧North Shields, Tyne & Wear, United Kingdom
King's College Hospital
🇬🇧Denmark Hill, London, United Kingdom
Thoraxklinik Heidelberg gGmbH
🇩🇪Heidelberg, Baden Wuerttemberg, Germany
Mayo Clinic - Rochester
🇺🇸Rochester, Minnesota, United States
Creighton University
🇺🇸Omaha, Nebraska, United States
G & L Research, LLC
🇺🇸Gulf Shores, Alabama, United States
Seoul National University Bundang Hospital
🇰🇷Seongnam, Gyeonggi-do, Korea, Republic of
Asan Medical Center
🇰🇷Seoul, Korea, Republic of
Samsung Medical Center
🇰🇷Seoul, Korea, Republic of
Pacific Clinical Research Network - Forte
🇳🇿Christchurch, New Zealand
Phoenix Medical Research Institute, LLC
🇺🇸Peoria, Arizona, United States
Allergy & Asthma Associates of Santa Clara Valley
🇺🇸San Jose, California, United States
AMR Norfolk, Formerly Tidewater Associates, an AMR Company
🇺🇸Norfolk, Virginia, United States
Clinical Research of Gastonia
🇺🇸Gastonia, North Carolina, United States
PMG Research of Charlotte, LLC
🇺🇸Charlotte, North Carolina, United States
Houston Pulmonary, Sleep, Allergy and Asthma Associates
🇺🇸Cypress, Texas, United States
The Prince Charles Hospital
🇦🇺Chermside, Queensland, Australia
Northside Health
🇦🇺Coffs Harbour, New South Wales, Australia
John Hunter Hospital
🇦🇺New Lambton Heights, New South Wales, Australia
Lung Research QLD Pty Ltd
🇦🇺Chermside, Queensland, Australia
MUDr. Jaroslav Mares - TBC a respir. nemoci
🇨🇿Strakonice, Czechia
MUDr. Otakar Hokynar plicni ordinace
🇨🇿Kralupy Nad Vltavou, Czechia
Plicni ambulance - MUDr. Ilona Pavlisova
🇨🇿Miroslav, Czechia
DAWON spol. s.r.o.
🇨🇿Prague, Czechia
Pneumologische Praxis Pasing
🇩🇪Muenchen, Bayern, Germany
Lungenzentrum Darmstadt
🇩🇪Darmstadt, Hessen, Germany
Studienzentrum Maingau
🇩🇪Frankfurt am main, Hessen, Germany
Klinikum der Johann Wolfgang Goethe-Universitaet
🇩🇪Frankfurt, Hessen, Germany
Medaimun GmbH
🇩🇪Frankfurt, Hessen, Germany
Pneumologisches Forschungsinstitut Hohegeest GbR
🇩🇪Geesthacht, Schleswig Holstein, Germany
Charité Universitaetsmedizin Berlin - Campus Charité Mitte
🇩🇪Berlin, Germany
KLB Gesundheitsforschung Luebeck GmbH
🇩🇪Luebeck, Schleswig Holstein, Germany
Arztezentrum in der Axel-Springer-Passage
🇩🇪Berlin, Germany
W. Pratiksha Hospital
🇮🇳Varanasi, Uttar Pradesh, India
Assured Care Plus Hospital
🇮🇳Nashik, Maharashtra, India
Pusan National University Hospital
🇰🇷Busan, Korea, Republic of
Jeonbuk national university hospital
🇰🇷Jeonju, Jeollabuk-do, Korea, Republic of
Seoul National University Hospital
🇰🇷Seoul, Korea, Republic of
The Catholic University of Korea, Seoul St. Mary's Hospital
🇰🇷Seoul, Korea, Republic of
Waikato Hospital
🇳🇿Hamilton, New Zealand
PNEUMO-MED s.r.o.
🇸🇰Prievidza, Slovakia
Zeleznicna nemocnica s poliklinikou
🇸🇰Košice, Slovakia
Kaohsiung Medical University Chung-Ho Memorial Hospital
🇨🇳Kaohsiung, Taiwan
Chang Gung Memorial Hospital,Linkou
🇨🇳Taoyuan, Taiwan
Accellacare Warwickshire
🇬🇧Coventry, West Midlands, United Kingdom
Ormeau Clinical Trials Ltd
🇬🇧Belfast, United Kingdom
Accellacare
🇺🇸Winston-Salem, North Carolina, United States
Pharmacorp Clinical Trials, Inc.
🇺🇸Charleston, South Carolina, United States
Changhua Christian Medical Foundation Changhua Christian Hospital
🇨🇳Chang Hua, Taiwan
E-DA Hospital
🇨🇳Kaohsiung, Taiwan
Paradigm Clinical Research Centers, Inc.
🇺🇸Redding, California, United States
Castle Hill Hospital
🇬🇧Cottingham, East Riding Of Yorkshire, United Kingdom