Evaluation of the Efficacy and Safety of BLU-5937 in Adults With Refractory Chronic Cough
- Registration Number
- NCT04678206
- Lead Sponsor
- Bellus Health Inc. - a GSK company
- Brief Summary
This is a randomized, double-blind, placebo-controlled, parallel-arm, Phase 2b adaptive dose-finding study of BLU-5937 in participants with Refractory Chronic Cough (RCC).
- Detailed Description
The primary objective of this study is to determine the therapeutic dose of BLU-5937 in patients with refractory chronic cough by assessing the change from baseline to week 4 in the 24-hour cough frequency with BLU-5937 relative to placebo.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 310
- 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 Placebo Placebo Matching Placebo for BLU-5937 oral dose twice a day. Placebo (Population with baseline cough < 25 coughs/hour) Placebo Matching Placebo for BLU-5937 oral dose twice a day. BLU-5937 Dose A BLU-5937 BLU-5937 oral dose A twice a day. BLU-5937 Dose B BLU-5937 BLU-5937 oral dose B twice a day. BLU-5937 Dose A (Population with baseline cough < 25 coughs/hour) BLU-5937 BLU-5937 oral dose A twice a day. BLU-5937 Dose C BLU-5937 BLU-5937 oral dose C twice a day.
- Primary Outcome Measures
Name Time Method Change from baseline in the 24-hour cough frequency Week 4 Assessed using an ambulatory cough monitor
- Secondary Outcome Measures
Name Time Method Change from Baseline in Leicester Cough Questionnaire (LCQ) Week 4 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 effect of cough on 3 main 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.
Incidence (% of subjects) of treatment-emergent adverse events (TEAEs) 2 Weeks after the last study medication intake Percentage of Participants with a Reduction from Baseline in the 24-hour Cough Frequency by ≥ 30%, 50% and 70% Week 4 Assessed using an ambulatory cough monitor
Change from baseline in cough severity Week 4 Assessed by Cough Severity Visual Analogue Scale \[VAS\] by the participant on a 100 mm visual analog scale where higher scores indicate worse severity.
Severity (mild, moderate, or severe) of treatment-emergent adverse events (TEAEs) 2 Weeks after the last study medication intake
Trial Locations
- Locations (115)
Montana Medical Research
🇺🇸Missoula, Montana, United States
Diex Recherche - Québec
🇨🇦Québec, Quebec, Canada
Inspiration Research Limited
🇨🇦Toronto, Quebec, Canada
Synexus Budapest - Magyarország Egészségügyi Szolgáltató Kft
🇭🇺Budapest, Hungary
Centrum Medyczne Bydgoszcz - PRATIA
🇵🇱Bydgoszcz, Kujawsko-pomorskie, Poland
Synexus Polska Sp. Z o.o Oddzial w Lodzi
🇵🇱Łódź, Lodzkie, Poland
MeDiNova Northamptonshire Quality Research Site
🇬🇧Corby, England, United Kingdom
MeDiNova South London Quality Research Site
🇬🇧Sidcup, England, United Kingdom
Wythenshawe Hospital - PPDS
🇬🇧Manchester, England, United Kingdom
Allergy Associates Medical Group Inc.
🇺🇸San Diego, California, United States
Mayo Clinic
🇺🇸Rochester, Minnesota, United States
Bernstein Clinical Research Center Inc
🇺🇸Cincinnati, Ohio, United States
Pharmaceutical Research & Consulting Inc
🇺🇸Dallas, Texas, United States
Clinical Research Associates Of Central Pa
🇺🇸Altoona, Pennsylvania, United States
Diagnostics Research Group
🇺🇸San Antonio, Texas, United States
Phoenix Medical Research Inc
🇺🇸Peoria, Arizona, United States
Little Rock Allergy and Asthma Clinical Research Center
🇺🇸Little Rock, Arkansas, United States
Southern California Institute For Respiratory Diseases, Inc
🇺🇸Los Angeles, California, United States
Allergy and Asthma Associates of Southern California
🇺🇸Mission Viejo, California, United States
California Medical Research Associates, Inc.
🇺🇸Northridge, California, United States
Colorado Allergy and Asthma Centers
🇺🇸Denver, Colorado, United States
Allergy and Asthma Associates of Santa Clara Valley Research Center
🇺🇸San Jose, California, United States
Floridian Clinical Research
🇺🇸Hialeah, Florida, United States
St. Francis Medical Institute
🇺🇸Clearwater, Florida, United States
Sweet Hope Research Specialty, Inc.
🇺🇸Hialeah, Florida, United States
Sher Allergy Specialist/Center for Cough
🇺🇸Largo, Florida, United States
Medical Research of Central Florida
🇺🇸Leesburg, Florida, United States
Lenus Research & Medical Group
🇺🇸Sweetwater, Florida, United States
IACT Health - Columbus
🇺🇸Columbus, Georgia, United States
IACT Health - Rincon
🇺🇸Rincon, Georgia, United States
IACT Health - Lawrenceville
🇺🇸Lawrenceville, Georgia, United States
AES - Synexus Clinical Research US, Inc. - Evansville
🇺🇸Evansville, Indiana, United States
Sneeze Wheeze and Itch Associates LLC
🇺🇸Normal, Illinois, United States
Abraham Research PLLC
🇺🇸Fort Mitchell, Kentucky, United States
Infinity Medical Research Inc
🇺🇸North Dartmouth, Massachusetts, United States
Minnesota Lung Center
🇺🇸Woodbury, Minnesota, United States
The Clinical Research Center LLC
🇺🇸Saint Louis, Missouri, United States
University of Missouri, ENT and Allergy Center of Missouri
🇺🇸Columbia, Missouri, United States
Creighton University Medical Center
🇺🇸Omaha, Nebraska, United States
Atlantic Respiratory Institute
🇺🇸Summit, New Jersey, United States
American Health Research Inc
🇺🇸Charlotte, North Carolina, United States
Clinical Research of Gastonia
🇺🇸Gastonia, North Carolina, United States
Remington Davis Inc
🇺🇸Columbus, Ohio, United States
Vital Prospects Clinical Research Institute PC
🇺🇸Tulsa, Oklahoma, United States
The Cleveland Clinic Foundation
🇺🇸Cleveland, Ohio, United States
Clinical Research of Rock Hill
🇺🇸Rock Hill, South Carolina, United States
El Paso Pulmonary Association
🇺🇸El Paso, Texas, United States
Clinical Trials Center of Middle Tennessee
🇺🇸Franklin, Tennessee, United States
Village Research, LLC
🇺🇸Houston, Texas, United States
Metroplex Pulmonary and Sleep Medicine Center
🇺🇸McKinney, Texas, United States
Sherman Clinical Research
🇺🇸Sherman, Texas, United States
Allergy Asthma Research Institute
🇺🇸Waco, Texas, United States
Intermountain Clinical Research
🇺🇸Draper, Utah, United States
TPMG Lung & Sleep Specialist
🇺🇸Williamsburg, Virginia, United States
McMaster University Medical Centre
🇨🇦Hamilton, Ontario, Canada
Clinique Spécialisée en Allergie de la Capitale
🇨🇦Québec, Quebec, Canada
C I C Maurice Inc
🇨🇦Trois-Rivières, Quebec, Canada
Diex Recherche - Victoriaville
🇨🇦Victoriaville, Quebec, Canada
MUDr. I. Cierná Peterová s.r.o.
🇨🇿Brandýs Nad Labem-Stará Boleslav, Central Bohemia, Czechia
Pneumologie Varnsdorf S.r.o.
🇨🇿Nový Bor, Liberec, Czechia
Plicní ambulance Rokycany s.r.o.
🇨🇿Rokycany, Plzeň, Czechia
Synexus Czech s.r.o.
🇨🇿Praha, Prague, Czechia
MediTrial s.r.o.
🇨🇿Jindřichův Hradec, South Bohemia, Czechia
MUDr. Jaroslav Mares - odborny lekar pro obor tuberkulosa a respiracni nemoci
🇨🇿Strakonice, South Bohemia, Czechia
Plicni stredisko Teplice s.r.o.
🇨🇿Teplice, Ústí Nad Labem, Czechia
Thoraxklinik-Heidelberg gGmbH
🇩🇪Heidelberg, Baden-Württemberg, Germany
Synexus Frankfurt Research Centre
🇩🇪Frankfurt am main, Hessen, Germany
Ballenberger. Freytag. Wenisch - Institut fuer klinische Forschung GmbH
🇩🇪Neu Isenburg, Hessen, Germany
IKF Pneumologie
🇩🇪Frankfurt, Hessen, Germany
Zentrum für ambulante pneumologische Forschung Marburg GbR
🇩🇪Marburg, Hessen, Germany
Kfns Klinische Forschung Schwerin
🇩🇪Schwerin, Mecklenburg-Vorpommern, Germany
Klinische Forschung Dresden GmbH (KFGN)
🇩🇪Dresden, Sachsen, Germany
Universitätsklinikum Bonn
🇩🇪Bonn, Nordrhein-Westfalen, Germany
Synexus Leipzig Research Centre
🇩🇪Leipzig, Sachsen, Germany
Da Vinci Maganklinika
🇭🇺Pécs, Baranya, Hungary
Szent Borbála Kórház
🇭🇺Tatabánya, Nograd, Hungary
Synexus Gyula - Magyarország Egészségügyi Szolgáltató Kft
🇭🇺Gyula, Békés, Hungary
Ärztezentrum Axel Springer Passage
🇩🇪Berlin, Germany
Dr. Kenessey Albert Korhaz-Rendelointezet
🇭🇺Balassagyarmat, Nógrád, Hungary
Synexus Zalaegerszeg Magyarország Egészségügyi Kft
🇭🇺Zalaegerszeg, Zala, Hungary
Medical Center Kermed
🇵🇱Bydgoszcz, Kujawsko-pomorskie, Poland
Osrodek Badan Klinicznych CLINSANTE S.C. Ewa Galczak-Nowak Malgorzata Trzaska
🇵🇱Bydgoszcz, Kujawsko-pomorskie, Poland
Clinical Best Solutions -Lublin
🇵🇱Lublin, Lubelskie, Poland
KLIMED
🇵🇱Bychawa, Lubelskie, Poland
Centrum Alergologii Specjalistyczna Przychodnia Alergologiczna
🇵🇱Lublin, Lubelskie, Poland
Centrum Medyczne Warszawa - PRATIA
🇵🇱Warszawa, Mazowieckie, Poland
Alergo-Med Specjalistyczna Przychodnia Lekarska Sp. z.o.o
🇵🇱Tarnów, Małopolskie, Poland
Prywatny Gabinet Internistyczno-Alergologiczny
🇵🇱Białystok, Podlaskie, Poland
Centrum Medyczne Wos i Piwowarczyk
🇵🇱Kraków, Łódzkie, Poland
Ostrowieckie Centrum Medyczne Spólka Cywilna Anna Olech-Cudzik, Krzysztof Cudzik
🇵🇱Ostrowiec Świętokrzyski, Świętokrzyskie, Poland
Synexus Polska Sp. z o.o. Oddzial w Gdansku
🇵🇱Gdansk, Pomorskie, Poland
Synexus Polska Sp. z o.o. Oddzial w Czestochowie
🇵🇱Częstochowa, Śląskie, Poland
Synexus Midlands Clinical Research Centre
🇬🇧Birmingham, England, United Kingdom
West Walk Surgery
🇬🇧Bristol, England, United Kingdom
Kings College Hospital
🇬🇧London, England, United Kingdom
MeDiNova North London Quality Research Site
🇬🇧Middlesex, England, United Kingdom
NW Consortium Manchester
🇬🇧Manchester, England, United Kingdom
MeDiNova Warwickshire Quality Research Site
🇬🇧Kenilworth, England, United Kingdom
North Tyneside General Hospital
🇬🇧North Shields, England, United Kingdom
MeDiNova East London Quality Research Site
🇬🇧Romford, England, United Kingdom
MeDiNova Yorkshire Quality Research Site
🇬🇧Shipley, England, United Kingdom
MeDiNova West London Quality Research Site
🇬🇧Wokingham, England, United Kingdom
Belfast City Hospital
🇬🇧Belfast, Northern Ireland, United Kingdom
AES - Synexus Scotland Clinical Research Centre
🇬🇧Glasgow, Scotland, United Kingdom
Ormeau Clinical Trials Limited
🇬🇧Belfast, Northern Ireland, United Kingdom
ProCare Clinical Research
🇺🇸Miami Lakes, Florida, United States
Synexus Clinical Research US, Inc.
🇺🇸Anderson, South Carolina, United States
The Lung Research Center, LLC
🇺🇸Chesterfield, Missouri, United States
Central Florida Pulmonary Group PA
🇺🇸Orlando, Florida, United States
CHEAR Center LLC
🇺🇸Bronx, New York, United States
Southeastern Research Center
🇺🇸Winston-Salem, North Carolina, United States
National Allergy and Asthma Research
🇺🇸Charleston, South Carolina, United States
Albuquerque Clinical Trials Inc
🇺🇸Albuquerque, New Mexico, United States
Royal Brompton Hospital
🇬🇧London, England, United Kingdom
Castle Hill Hospital
🇬🇧Cottingham, England, United Kingdom