Clinical Trials List
Protocol NumberBAY 1817080 / 20393
NCT Number(ClinicalTrials.gov Identfier)NCT04562155
Completed
2020-04-01 - 2022-05-31
Phase II
Recruiting5
ICD-10R05
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)
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Trial Applicant
BAYER TAIWAN COMPANY LTD.
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Sponsor
Bayer
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Trial scale
Multi-Regional Multi-Center
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Update
2026/02/01
Investigators and Locations
Co-Principal Investigator
- 王俊隆 無
- 王振宇 無
- Wei- Chang Huang 無
The Actual Total Number of Participants Enrolled
0 Recruiting
The Actual Total Number of Participants Enrolled
0 Recruiting
The Actual Total Number of Participants Enrolled
0 Recruiting
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
The Actual Total Number of Participants Enrolled
0 Recruiting
Condition/Disease
refractory and/or unexplained chronic cough (RUCC)
Objectives
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.
Test Drug
BAY 1817080
Active Ingredient
BAY 1817080
Dosage Form
tablet
tablet
tablet
Dosage
25mg/ 100mg
Endpoints
Primary Outcome Measures :
Change from baseline in 24-hour cough count (measured by cough recording digital wearable monitoring device) after 12 weeks of intervention [ Time Frame: From baseline up to 12 weeks ]
Secondary Outcome Measures :
Percentage of participants with a ≥30% reduction from baseline in 24-hour cough count after 12 weeks of intervention (measured by cough recording digital wearable monitoring device) [ Time Frame: From baseline up to 12 weeks ]
Change from baseline in 24-hour cough count after 2, 4, and 8 weeks of intervention (measured by cough recording digital wearable monitoring device) [ Time Frame: From baseline up to 2 weeks, 4 weeks and 8 weeks ]
Change from baseline in awake cough frequency per hour after 2, 4, 8 and 12 weeks of intervention (measured by cough recording digital wearable monitoring device) [ Time Frame: From baseline up to 2 weeks, 4 weeks, 8 weeks and 12 weeks ]
Change from baseline in cough related quality of life (measured by Leicester Cough Questionnaire [LCQ]) after 12 weeks of intervention [ Time Frame: From baseline up to 12 weeks ]
Change from baseline in cough severity after 12 weeks of intervention (measured by Cough Severity Visual Analogue Scale [VAS]) [ Time Frame: From baseline up to 12 weeks ]
Percentage of participants with a ≥30 scale units reduction from baseline after 12 weeks of intervention (measured by cough Severity VAS) [ Time Frame: From baseline up to 12 weeks ]
Percentage of participants with a ≥1.3-point increase from baseline after 12 weeks of intervention (measured with LCQ Total Score) [ Time Frame: From baseline up to 12 weeks ]
Frequency and associated severity of treatment-emergent adverse events (TEAEs) [ Time Frame: From the start of study intervention administration until 14 days after the last study medication intake ]
Change from baseline in 24-hour cough count (measured by cough recording digital wearable monitoring device) after 12 weeks of intervention [ Time Frame: From baseline up to 12 weeks ]
Secondary Outcome Measures :
Percentage of participants with a ≥30% reduction from baseline in 24-hour cough count after 12 weeks of intervention (measured by cough recording digital wearable monitoring device) [ Time Frame: From baseline up to 12 weeks ]
Change from baseline in 24-hour cough count after 2, 4, and 8 weeks of intervention (measured by cough recording digital wearable monitoring device) [ Time Frame: From baseline up to 2 weeks, 4 weeks and 8 weeks ]
Change from baseline in awake cough frequency per hour after 2, 4, 8 and 12 weeks of intervention (measured by cough recording digital wearable monitoring device) [ Time Frame: From baseline up to 2 weeks, 4 weeks, 8 weeks and 12 weeks ]
Change from baseline in cough related quality of life (measured by Leicester Cough Questionnaire [LCQ]) after 12 weeks of intervention [ Time Frame: From baseline up to 12 weeks ]
Change from baseline in cough severity after 12 weeks of intervention (measured by Cough Severity Visual Analogue Scale [VAS]) [ Time Frame: From baseline up to 12 weeks ]
Percentage of participants with a ≥30 scale units reduction from baseline after 12 weeks of intervention (measured by cough Severity VAS) [ Time Frame: From baseline up to 12 weeks ]
Percentage of participants with a ≥1.3-point increase from baseline after 12 weeks of intervention (measured with LCQ Total Score) [ Time Frame: From baseline up to 12 weeks ]
Frequency and associated severity of treatment-emergent adverse events (TEAEs) [ Time Frame: From the start of study intervention administration until 14 days after the last study medication intake ]
Inclution Criteria
Inclusion Criteria:
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.
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.
Exclusion Criteria
Exclusion Criteria:
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.
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.
The Estimated Number of Participants
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Taiwan
18 participants
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Global
participants
