A 52-Week Study of the Efficacy and Safety of BLU-5937 in Adults With Refractory Chronic Cough
Refractory Chronic CoughThis is a randomized, double-blind, placebo-controlled, parallel-arm, Phase 3 study of BLU-5937 in participants with Refractory Chronic Cough (RCC).
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Conditions de participation
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Sexe:
ALL -
Âges admissibles:
18 to 80
Critères de participation
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
Lieu de l'étude
Dynamic Drug Advancement
Dynamic Drug AdvancementAjax, Ontario
Canada
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Inspiration Research Limited
Inspiration Research LimitedToronto, Ontario
Canada
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Institut Universitaire de Cardiologie et de Pneumologie de Quebec
Institut Universitaire de Cardiologie et de Pneumologie de QuebecQuébec, Quebec
Canada
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CIC Mauricie Inc.
CIC Mauricie Inc.Trois-Rivières, Quebec
Canada
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Kelowna Respirology and Asthma Research
Kelowna Respirology and Asthma ResearchKelowna, British Columbia
Canada
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McMaster University Health Sciences Center
McMaster University Health Sciences CenterHamilton, Ontario
Canada
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Montreal Chest Institute
Montreal Chest InstituteMontréal, Quebec
Canada
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Clinique de pneumologie et du sommeil de Lanaudière
Clinique de pneumologie et du sommeil de LanaudièreSaint-Charles-Borromée, Quebec
Canada
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University of Calgary - Health Sciences Centre
University of Calgary - Health Sciences CentreCalgary, Alberta
Canada
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Burlington Lung Clinic
Burlington Lung ClinicBurlington, Ontario
Canada
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Dr. Syed Anees Medicine Professional Corporation
Dr. Syed Anees Medicine Professional CorporationWindsor, Ontario
Canada
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DIEX Recherche Quebec Inc.
DIEX Recherche Quebec Inc.Québec, Quebec
Canada
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DIEX Recherche Victoriaville Inc.
DIEX Recherche Victoriaville Inc.Victoriaville, Quebec
Canada
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Peak Research Group
Peak Research GroupCalgary, Alberta
Canada
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Hamilton Medical Research Group
Hamilton Medical Research GroupHamilton, Ontario
Canada
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CISSS de la Monteregie-Centre
CISSS de la Monteregie-CentreGreenfield Park, Quebec
Canada
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Clinique Specialisee en Allergie de la Capitale
Clinique Specialisee en Allergie de la CapitaleQuébec, Quebec
Canada
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- Étude parrainée par
- Bellus Health Inc. - a GSK company
- Participants recherchés
- Plus d'informations
- ID de l'étude:
NCT05599191