NCT04562155

Clinical Study to Evaluate the Efficacy and Safety of Three Different Doses of BAY1817080 Compared to Placebo in Patients With Chronic Cough

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)

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 310 (actual)
• Sponsor: Bayer · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Refractory and/or Unexplained Chronic Cough

Interventions

Type	Name	Description
DRUG	BAY1817080	Study drug BAY1817080 will be administered orally as tablet.
DRUG	Placebo	Matching Placebo for BAY1817080 will be administered orally as tablet.

Timeline

• Start date: 2020-10-02
• Primary completion: 2021-06-22
• Completion: 2021-07-23
• First posted: 2020-09-24
• Last updated: 2022-08-18
• Results posted: 2022-08-18

Locations

99 sites across 19 countries: United States, Argentina, Australia, Belgium, Canada, Czechia, France, Germany, Hungary, Italy, Japan, Netherlands, Poland, Russia, Slovakia, Spain, Taiwan, Turkey (Türkiye), United Kingdom

Regulatory

• FDA-regulated drug study