A Randomized, Adaptive, Double-Blind, Placebo-Controlled, Parallel-Arm,Phase 2b Study to Evaluate the Efficacy and Safety of Multiple Doses ofBLU-5937 in Adult Participants With Refractory Chronic Cough - SOOTHE

Bellus Health Inc.0 个研究点目标入组 240 人开始时间: 2020年12月9日最近更新: 2022年1月4日

研究概览

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•1. Is capable of understanding the written informed consent, provides signed and witnessed written informed consent, and agrees to comply with protocol requirements.
•2. Is between the ages of 18 and 80 years, inclusive.
•3. Has had RCC (including unexplained chronic cough) for at least 1 year prior to screening, defined as follows: a) insufficient improvement in cough after treatment for the underlying condition causing the cough OR b) unexplained cough for which an underlying condition has not been determined.
•4. Has had a chest radiograph or CT thorax within the 5 years before screening and following the onset of chronic cough that does not show any abnormality considered to be significantly contributing to the chronic cough, as per the investigator opinion.
•5. Has an awake cough frequency of =25 coughs/hour at screening and at Day -6. For the low-cough cohort, awake cough frequency of =10 to <25 coughs/hour at screening and at Day -6.
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 200
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 40

•1. Female participants who are pregnant, trying to become pregnant, or lactating.
•2. Current smoker/vaper or current use of the following inhaled substances (eg, tobacco or cannabis smoke, nicotine vapors).
•3. Individuals who have given up smoking or vaping within the past 6 months or those with a >20 pack-year smoking history.
•4. Diagnosis of COPD, bronchiectasis, or idiopathic pulmonary fibrosis based on clinician assessment.
•5. Uncontrolled asthma defined as one or both of the following:
•=1 exacerbation in the last 6 months or =2 exacerbations in the last 12 months
•Use of rescue medication =3 days per week or night waking >1 time per week (Pre-exercise prophylactic medication use will not be considered rescue medication.)

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