Randomized, double-blind, parallel group, Phase 2b dose-finding, efficacy and safety study of 12-week twice daily oral administration of BAY 1817080 compared to placebo in the treatment of refractory and/or unexplained chronic cough (RUCC)
- Conditions
- refractory and/or unexplained chronic cough (RUCC)10006436
- Registration Number
- NL-OMON50167
- Lead Sponsor
- Bayer
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 8
1. Adults * 18 years of age at the time of signing the informed consent.
2. A cough that has lasted for at least 12 months with persistently bothersome
refractory (unresponsive to treatment options) or idiopathic (unexplained)
chronic cough.
3. persistent cough for at least 8 weeks before screening.
4. Women of childbearing potential must agree to use acceptable effective or
highly effective birth control methods during the study and for at least 30
days after the last dose.
5. Capable of giving signed informed consent.
1. Smoking history within the last 12 months before screening (all forms of
smoking, including e-cigarettes, cannabis and others), and any former smoker
with more than 20 pack-years.
2. Ongoing or previous exposure to inhalational toxic fumes (e.g., ammonia,
chlorine, nitrogen dioxide, phosgene and sulfur dioxide) within the last 12
months before screening.
3. Respiratory tract infection within 4 weeks before screening.
4. History of chronic bronchitis.
5.Systolic blood pressure * 160 mmHg and/or diastolic blood pressure * 100 mmHg
at screening visit.
6. Positive SARS-CoV-2 virus RNA and/or serology IgG tests at screening visit.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Change from baseline in 24-hour cough count (measured by cough recording<br /><br>digital wearable monitoring device) after 12 weeks of intervention</p><br>
- Secondary Outcome Measures
Name Time Method