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NCT04562155 · ClinicalTrials.gov registry record · Phase 2
Clinical Study to Evaluate the Efficacy and Safety of Three Different Doses of BAY1817080 Compared to Placebo in Patients With Chronic Cough
A Phase 2 study of Refractory and/or Unexplained Chronic Cough, sponsored by Bayer.
- Completed
- Registry status
- Phase 2
- Development phase
- 310
- Enrollment target
- 20
- Study locations
NCT04562155: Completed Phase 2 study of Refractory and/or Unexplained Chronic Cough, sponsored by Bayer.
NCT04562155 is a Phase 2 study of Refractory and/or Unexplained Chronic Cough that has completed, run by Bayer. The registered enrollment target is 310 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (133% higher). The trial reports 20 study locations across 14 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04562155, a Phase 2 study of Refractory and/or Unexplained Chronic Cough, has completed, sponsored by Bayer.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 310 participants
- Enrollment target
- 20
- Study locations
Study Summary
Researchers in this study want to find the optimal therapeutic dose of drug BAY1817080 for patients with long-standing cough with or without clear causes (refractory and/or unexplained chronic cough, RUCC). Study drug BAY1817080 is a new drug under development for the treatment of long-standing cough. It blocks proteins that are expressed by the airway sensory nerves which are oversensitive in patients with long-standing cough. This prevents the urge to cough. Researchers also want to learn the safety of the study drug and how well it works in reducing the cough frequency, severity and urge-to-cough. Participants in this study will receive either the study drug or placebo (a placebo looks like the test drug but does not have any medicine in it) tablets twice daily for 12 weeks. Observation for each participant will last about 18 weeks in total. Participants will be asked to wear a digital device to record the cough and to complete questionnaires every day to document the symptoms. Blood samples will be collected from the participants to monitor the safety and measure the blood level of the study drug.
Primary Outcome
The raw 24-hour cough count measured by cough recording digital wearable monitoring device was standardized to an average hourly count. For the ratio between the geometric means of 24-hour cough count, the geometric mean of 24-hour cough count after 12 weeks of intervention was divided by the geometric mean of 24-hour cough count at baseline. btw = between geo = geometric
Conditions Studied
Interventions
- DRUG Placebo
- DRUG BAY1817080
Study Locations (20)
Ciudad Auton. de Buenos Aires
- Centro Médico Dra. De Salvo - Clinical Research Center - Buenos Aires
- Centro de Investigaciones Clínicas - CABA
- Fundación CIDEA - CABA
- Investigación en Alergias y Enfermedades Respiratorias-INAER - CABA
New South Wales
- Macquarie University Hospital - Macquarie University
- Maroubra Medical Centre - Maroubra
- Holdsworth House Medical Practice - Sydney
Buenos Aires
- Instituto Ave Pulmo - Mar del Plata
- Centro Respiratorio Quilmes - Quilmes
California
- California Allergy & Asthma Medical Group & Research Center - Los Angeles
Florida
- Florida Pediatrics - Largo
Maryland
- Chesapeake Clinical Research, Inc. - White Marsh
Minnesota
- Minnesota Lung Center - Edina
Montana
- Montana Medical Research, Inc - Missoula
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 310 participants |
| Start Date | 2020-10-02 |
| Est. Completion | 2021-07-23 |
| Phase | Phase 2 |
What the finished NCT04562155 record still lists
NCT04562155 is an interventional study that assigns participants to a tested intervention. The registered 310 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (133% higher).
The record links to 1 condition, with Refractory and/or Unexplained Chronic Cough appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT04562155 names 20 study sites across 14 states, led by Ciudad Auton. de Buenos Aires, New South Wales, Buenos Aires.
Frequently Asked Questions
What is clinical trial NCT04562155 about?
NCT04562155 is a clinical study titled "Clinical Study to Evaluate the Efficacy and Safety of Three Different Doses of BAY1817080 Compared to Placebo in Patients With Chronic Cough". Researchers in this study want to find the optimal therapeutic dose of drug BAY1817080 for patients with long-standing cough with or without clear causes (refractory and/or unexplained chronic cough, RUCC). Study drug BAY1817080 is a new drug under development for the treatment of long-standing coug...
What is the current status of trial NCT04562155?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 310 participants. The study started on 2020-10-02. Estimated completion is 2021-07-23.
What conditions does trial NCT04562155 study?
This clinical trial studies the following conditions: Refractory and/or Unexplained Chronic Cough.
What interventions are being tested in trial NCT04562155?
The interventions under investigation include: Placebo (DRUG), BAY1817080 (DRUG).
Who is sponsoring clinical trial NCT04562155?
This trial is sponsored by Bayer, which has 591 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04562155 being conducted?
This trial has 20 study locations across California, Florida, Maryland, Minnesota, Montana. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04562155's enrollment target sits among peer trials
310 162nd of 2000 higher than 1,838 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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