Clinical Study to Evaluate the Efficacy and Safety of Three Different Doses of BAY1817080 Compared to Placebo in Patients With Chronic Cough

Phase 2

• Conditions: Refractory and/or Unexplained Chronic Cough

• Registration Number: JPRN-jRCT2031200185
• Lead Sponsor: Myoishi Masashi

Brief Summary

The study met its objective to detect a dose-response signal of eliapixant for the treatment of RUCC. The identified optimal dose was 75 mg BID, showing a clinically relevant effect in cough count reduction after 12 weeks of intervention and a good safety and tolerability profile. The only study intervention-related serious TEAE was observed in the 150 mg BID group and was a case of moderate drug-induced liver injury.

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-11-06
• Study Completion: 2021-07-23
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 310

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.

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change from baseline in 24-hour cough count (measured by cough recording digital wearable monitoring device) after 12 weeks of intervention