Clinical study to evaluate the efficacy and safety of three different doses of BAY 1817080 compared to placebo in patients with chronic cough
- Conditions
- Refractory and/or unexplained chronic cough (RUCC)MedDRA version: 21.0Level: LLTClassification code 10080782Term: Refractory chronic coughSystem Organ Class: 100000004855MedDRA version: 21.0Level: LLTClassification code 10080781Term: Unexplained chronic coughSystem Organ Class: 100000004855Therapeutic area: Diseases [C] - Symptoms and general pathology [C23]
- Registration Number
- EUCTR2019-004169-42-IT
- Lead Sponsor
- Bayer AG
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- 236
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 with persistently
bothersome refractory (unresponsive to treatment options) or idiopathic
(unexplained) chronic cough that has lasted for at least 8 weeks before
screening.
3. 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.
4. Capable of giving signed informed consent.
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
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. Respiratory tract infection within 4 weeks before screening.
4. History of chronic bronchitis.
5. Uncontrolled hypertension despite optimal treatment with
antihypertensive(s), indicated by a sitting systolic blood pressure = 180
mmHg and/or diastolic blood pressure = 110 mmHg.
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