NL-OMON56306
Recruiting
Phase 3
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 (CALM-1) - BUS-P3-01 (CALM-1)
Overview
- Phase
- Phase 3
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Bellus Health, Inc.
- Enrollment
- 24
- Status
- Recruiting
- Last Updated
- last year
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\. Between 18 and 80 years of age inclusive, at the time of signing the
- •informed consent 2\. Capable of understanding the written informed consent as
- •described in Appendix 1, Section 10\.1\.5, which includes compliance with the
- •requirements and restrictions listed in the Informed Consent Form (ICF) and in
- •this protocol, provides signed and witnessed written informed consent, and
- •agrees to comply with protocol requirements including being available for the
- •duration of the study 3\. After investigation into potential underlying causes
- •of chronic cough, have a diagnosis of RCC defined as: a) insufficient
- •improvement in cough after treatment for the underlying condition(s)
- •contributing to their cough, OR b) unexplained cough for which an underlying
Exclusion Criteria
- •1\. Current smoker or vaper or current use of tobacco smoke, cannabis smoke, or
- •nicotine vapors 2\. Individuals who have given up smoking or vaping within the
- •past 6 months, or those with \> 20 pack\-year smoking history 3\. Diagnosis of
- •chronic obstructive pulmonary disease, bronchiectasis, chronic bronchitis,
- •cystic fibrosis, pulmonary sarcoidosis, idiopathic pulmonary fibrosis, or other
- •significant or progressive airway/respiratory disorder that might affect cough
- •based on clinician assessment 4\. History of upper and/or lower respiratory
- •tract infection or significant change in pulmonary status within 28 days of
- •Screening or during Screening or the Single\-blind Placebo Run\-in 5\. Laboratory
- •confirmed severe acute respiratory syndrome coronavirus\-2 (SARS\-CoV\-2\)
Outcomes
Primary Outcomes
Not specified
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