Clinical study to evaluate the efficacy and safety of three different doses of BAY 1817080 compared to placebo in patients with chronic cough

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: All

Target Recruitment: 236

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

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 < 60% or a history of frequent exacerbations of chronic obstructive pulmonary disease (COPD).
5. Respiratory tract infection within 4 weeks before screening.
6. History of chronic bronchitis.
7. Active state of massive hemoptysis or pulmonary hemorrhage, including those events managed by bronchial artery embolization or any history of bronchial artery embolization or massive hemoptysis within 3 months prior to screening.
8. Moderate-to-severe hepatic impairment defined as Child-Pugh Class B or C.
9. ALT >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.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: Assess the efficacy of P2X3 receptor antagonist BAY1817080 as<br>compared with placebo in terms of change in 24-hour cough count from<br>baseline to week 12;Secondary Objective: Further assess the efficacy, safety and tolerability profile of<br>BAY1817080 in patients with RCC;Primary end point(s): Change from baseline in 24-hour cough count (measured by cough<br>recording digital wearable monitoring device) after 12 weeks of<br>intervention;Timepoint(s) of evaluation of this end point: From baseline up to 12 weeks

Secondary Outcome Measures

Name	Time	Method

Updated 8/19/2024

Clinical study to evaluate the efficacy and safety of three different doses of BAY 1817080 compared to placebo in patients with chronic cough

Recruitment & Eligibility

Study & Design

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