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COMPLETED Phase 2

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

NCT04562155 · View on ClinicalTrials.gov ↗

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.

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

FieldValue
Enrollment Target 310 participants
Start Date 2020-10-02
Est. Completion 2021-07-23
Phase Phase 2

Sponsor

Bayer

143 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT04562155

The ClinicalTrials.gov registry entry for NCT04562155 describes a study currently listed as completed. It is categorized as Phase 2, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 310 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Bayer, which has 143 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT04562155 reports 20 study locations spanning 14 distinct geographic areas — top geographies include Ciudad Auton. de Buenos Aires, New South Wales, Buenos Aires. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT04562155?

The interventions under investigation include: Placebo (DRUG), BAY1817080 (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT04562155?

This trial is sponsored by Bayer, which has 143 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

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.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial