Clinical Study to Evaluate the Efficacy and Safety of Three Different Doses of BAY1817080 Compared to Placebo in Patients With Chronic Cough (PAGANINI)
- Conditions
- Refractory and/or Unexplained Chronic Cough
- Registration Number
- jRCT2031200185
- Lead Sponsor
- Bayer Yakuhin, Ltd.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 236
-Adults >= 18 years of age at the time of signing the informed consent. -A cough that has lasted for at least 12 months (unresponsive to treatment options) with a diagnosis of refractory chronic cough and/or idiopathic (unexplained) chronic cough. -Persistent cough for at least the last 8 weeks before screening. -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. -Capable of giving signed informed consent.
-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. -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. -Respiratory tract infection within 4 weeks before screening. -History of chronic bronchitis. -Systolic blood pressure >= 160 mmHg and/or diastolic blood pressure >= 100 mmHg at screening visit. -Positive SARS-CoV-2 virus RNA and/or serology IgG tests at screening visit.
Study & Design
- Study Type
- Interventional
- Study Design
- parallel assignment
- Primary Outcome Measures
Name Time Method Change from baseline in 24-hour cough count after 12 weeks of intervention measured by cough recording digital wearable monitoring device
- Secondary Outcome Measures
Name Time Method Percentage of participants with a >= 30% reduction from baseline in 24-hour cough count after 12 weeks of intervention after 12 weeks of intervention Percentage of participants with a >= 30% reduction from baseline in 24-hour cough count (measured by cough recording digital wearable monitoring device)
Change from baseline in 24-hour cough count after 2, 4, and 8 weeks of intervention after 2, 4, and 8 weeks of intervention Change from baseline in 24-hour cough count (measured by cough recording digital wearable monitoring device)
Change from baseline in awake cough frequency per hour after 2, 4, 8 and 12 weeks of intervention after 2, 4, 8 and 12 weeks of intervention Change from baseline in awake cough frequency per hour (measured by cough recording digital wearable monitoring device)
Change from baseline in cough related quality of life after 12 weeks of intervention after 12 weeks of intervention Change from baseline in cough related quality of life (measured by Leicester Cough Questionnaire [LCQ])
Change from baseline in cough severity after 12 weeks of intervention after 12 weeks of intervention Change from baseline in cough severity (measured by Cough Severity Visual Analogue Scale [VAS])
Percentage of participants with a >= 30 scale units reduction from baseline after 12 weeks of intervention after 12 weeks of intervention Percentage of participants with a >= 30 scale units reduction from baseline (measured by cough Severity VAS)
Percentage of participants with a >= 1.3-point increase from baseline after 12 weeks of intervention after 12 weeks of intervention Percentage of participants with a >= 1.3-point increase from baseline (measured with LCQ Total Score)
Frequency and associated severity of treatment-emergent adverse events (TEAEs) Frequency and associated severity of treatment-emergent adverse events (TEAEs)