A Study of the Safety and Efficacy of BLU-5937 for the Treatment of Chronic Cough

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 240

Inclusion Criteria

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

Exclusion Criteria

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.)

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: The primary objective of this study is to assess the efficacy of BLU-5937 for the treatment of refractory chronic cough (RCC).<br>;Secondary Objective: The secondary objective is to establish the optimal therapeutic doses for the Phase 3 studies;Primary end point(s): Change from baseline to Day 28 in the 24-hour cough frequency (as coughs/hour), as assessed by a cough monitor.;Timepoint(s) of evaluation of this end point: At the end of each dose level

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): (i) Change from baseline to Days 15 and 28 in awake cough/hour frequency as assessed by a cough monitor<br>(ii) Awake cough response (defined as a =30%, =50%, or =70% reduction from treatment baseline in awake cough/hour frequency at Days 15 and 28)<br>(iii) Change from baseline of nighttime cough frequency at Days 15 and 28, as assessed by a cough monitor<br>(iv) Change from baseline to Day 15 in 24-hour frequency (coughs/hour), as assessed by a cough monitor<br>(v) 24-hour cough response (defined as a =30%, =50%, or =70% reduction from treatment baseline in 24-hour cough/hour frequency) at Days 15 and 28;Timepoint(s) of evaluation of this end point: • Day 15 and Day 28<br>• Day 15 and Day 28<br>• Day 15 and Day 28, as assessed by a cough monitor <br>• Day 15 in 24-hour frequency (coughs/hour) <br>• Day 15 and Day 28<br><br><br>

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