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)
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)
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.
Inclusion Criteria:
Exclusion Criteria:
Los Angeles, California 90025, United States
Buenos Aires, Ciudad Auton. de Buenos Aires C1426ABP, Argentina
CABA, Ciudad Auton. de Buenos Aires C1018DES, Argentina
CABA, Ciudad Auton. de Buenos Aires C1121ABE, Argentina
CABA, Ciudad Auton. de Buenos Aires C1425, Argentina
Macquarie University, New South Wales 2109, Australia
Saint-Charles-Borromée, Quebec J6E 2B4, Canada
Yoshida, Fukui 910-1193, Japan
Shinagawa-ku, Tokyo 140-8522, Japan
Santiago de Compostela, A Coruña 15706, Spain