At a glance
ClinicalIndex Comparison Record- ✓Age 18 years or older at time of informed consent
- ✓Chronic cough lasting ≥12 months, diagnosed as refractory and/or idiopathic (unexplained), unresponsive to treatment options
- ✓Persistent cough for ≥8 weeks immediately before screening
- ✕Any smoking within past 12 months (all forms including e-cigarettes and cannabis)
- ✕Former smoker with >20 pack-year history
- ✕Ongoing or prior exposure to inhalational toxic fumes (ammonia, chlorine, nitrogen dioxide, phosgene, sulfur dioxide) within past 12 months
- ✕Respiratory tract infection within 4 weeks before screening
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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)
In Brief
A Phase 2 clinical trial evaluating BAY1817080 and Placebo for Refractory and/or Unexplained Chronic Cough. Completed, enrolled 310 participants across 99 sites in 19 countries.
Detailed Summary
Researchers in this study want to find the optimal therapeutic dose of drug BAY1817080 for patients with long-standing cough with or without clear causes (refractory and/or unexplained chronic cough, RUCC). Study drug BAY1817080 is a new drug under development for the treatment of long-standing cough. It blocks proteins that are expressed by the airway sensory nerves which are oversensitive in patients with long-standing cough. This prevents the urge to cough. Researchers also want to learn the safety of the study drug and how well it works in reducing the cough frequency, severity and urge-to-cough. Participants in this study will receive either the study drug or placebo (a placebo looks like the test drug but does not have any medicine in it) tablets twice daily for 12 weeks. Observation for each participant will last about 18 weeks in total. Participants will be asked to wear a digital device to record the cough and to complete questionnaires every day to document the symptoms. Blood samples will be collected from the participants to monitor the safety and measure the blood level of the study drug.
Study Details
Timeline
Interventions
Study drug BAY1817080 will be administered orally as tablet.
Matching Placebo for BAY1817080 will be administered orally as tablet.