Refractory and/or unexplained chronic cough (RUCC) MedDRA version: 21.0 Level: LLT Classification code 10080782 Term: Refractory chronic cough System Organ Class: 100000004855 MedDRA version: 21.0 Level: LLT Classification code 10080781 Term: Unexplained chronic cough System Organ Class: 100000004855
Conditions
Sponsors
Bayer AG
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Adults = 18 years of age at the time of signing the informed consent. 2. 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. 3. Persistent cough for at least the last 8 weeks before screening. 4. Cough severity as measured by VAS =40 scale units at screening. 5. 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. 6. Capable of giving signed informed consent, which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 100 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 136
Exclusion criteria
Exclusion criteria: 1. 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. 2. 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. 3. Chest radiograph or CT within the last 24 months before screening and subsequent to the onset of chronic cough with presence of any obvious lung disease that could be responsible or contributing for the cough (e.g., bronchiectasis, cavitary lesions, interstitial pulmonary fibrosis, pneumothorax, pleural disease, unstable rib fracture, tuberculosis). 4. Forced expiratory volume in 1 second (FEV1)/ Forced vital capacity (FVC) ratio 2xULN, or AST >2xULN, or total bilirubin greater than ULN, or alkaline phosphatase (AP) >2x ULN, or INR greater than ULN (unless related to anticoagulation treatment). 10. Estimated glomerular filtration rate (eGFR) <30 mL/min/1.73 m2 calculated by Modification of Diet in Renal Disease (MDRD) formula. 11. Systolic blood pressure = 160 mmHg and/or diastolic blood pressure = 100 mmHg at screening visit. 12. Esophageal achalasia. 13. Positive SARS-CoV-2 virus RNA and/or serology IgG tests at screening visit.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Assess the efficacy of P2X3 receptor antagonist BAY1817080 as compared with placebo in terms of change in 24-hour cough count from baseline to week 12;Secondary Objective: Further assess the efficacy, safety and tolerability profile of BAY1817080 in patients with RCC;Primary end point(s): Change from baseline in 24-hour cough count (measured by cough recording digital wearable monitoring device) after 12 weeks of intervention;Timepoint(s) of evaluation of this end point: From baseline up to 12 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1. Frequency and associated severity of treatment-emergent adverse events (TEAEs) 2. 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) 3. Change from baseline in 24-hour cough count after 2, 4, and 8 weeks of intervention (measured by cough recording digital wearable monitoring device) 4. 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) 5. Change from baseline in cough related quality of life (measured by Leicester Cough Questionnaire [LCQ]) after 12 weeks of intervention 6. Change from baseline in cough severity after 12 weeks of intervention (measured by Cough Severity Visual Analogue Scale [VAS]) 7. Percentage of participants with a =30 scale units reduction from baseline after 12 weeks of intervention (measured by cough Severity VAS) 8. Percentage of participants with a =1.3-point increase from baseline after 12 weeks of intervention (measured with LCQ Total Score);Timepoint(s) of evaluation of this end point: 1. From the start of study intervention until 14 days after the last study medication intake 2. From baseline up to 12 weeks 3. From baseline up to 2 weeks, 4 weeks, and 8 weeks 4. From baseline up to 2 weeks, 4 weeks, 8 weeks, and 12 weeks 5 - 8. From baseline up to 12 weeks | — |
Countries
Argentina, Australia, Belgium, Canada, Czechia, Czech Republic, France, Germany, Hungary, Italy, Japan, Netherlands, Poland, Russian Federation, Slovakia, Spain, Taiwan, Turkey, United Kingdom, United States
Contacts
Public ContactBayer Clinical Trial Contacts
Bayer AG
Outcome results
None listed