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

Phase 1

• Conditions: Refractory and/or unexplained chronic cough (RUCC); MedDRA version: 21.0Level: LLTClassification code 10080782Term: Refractory chronic coughSystem Organ Class: 100000004855; MedDRA version: 21.0Level: LLTClassification code 10080781Term: Unexplained chronic coughSystem Organ Class: 100000004855; Therapeutic area: Diseases [C] - Symptoms and general pathology [C23]

• Registration Number: EUCTR2019-004169-42-DE
• Lead Sponsor: Bayer AG

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-02-12
• Study Completion: 2021-07-23
• Last Update Posted: 8 August 2022

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 310

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. 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.
5. 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

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. Respiratory tract infection within 4 weeks before screening.
4. History of chronic bronchitis.
5. Systolic blood pressure = 160 mmHg and/or diastolic blood pressure = 100 mmHg at screening visit.
6. 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