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

Completed · Phase 2 · Has a placebo group

Conditions studied: Refractory and/or Unexplained Chronic Cough

In brief

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.

Key facts

Study ID

NCT04562155

Run by

Bayer

People needed

310

Starts

2020-10-02

Expected to finish

2021-07-23

Last updated by the study team

2022-08-18

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Florida Pediatrics — Largo, Florida, United States
• Chesapeake Clinical Research, Inc. — White Marsh, Maryland, United States
• Minnesota Lung Center — Edina, Minnesota, United States
• Montana Medical Research, Inc — Missoula, Montana, United States
• Vanderbilt University Medical School — Nashville, Tennessee, United States
• Pharmaceutical Research & Consulting, Inc. — Dallas, Texas, United States
• Bellingham Asthma, Allergy & Immunology Clinic — Bellingham, Washington, United States
• Instituto Ave Pulmo — Mar del Plata, Buenos Aires, Argentina
• Centro Respiratorio Quilmes — Quilmes, Buenos Aires, Argentina
• Centro Médico Dra. De Salvo - Clinical Research Center — Buenos Aires, Ciudad Auton. de Buenos Aires, Argentina
• Centro de Investigaciones Clínicas — CABA, Ciudad Auton. de Buenos Aires, Argentina
• Fundación CIDEA — CABA, Ciudad Auton. de Buenos Aires, Argentina
• Investigación en Alergias y Enfermedades Respiratorias-INAER — CABA, Ciudad Auton. de Buenos Aires, Argentina
• Investigaciones en Patologías Respiratorias — San Miguel de Tucumán, Tucumán Province, Argentina
• Macquarie University Hospital — Macquarie University, New South Wales, Australia
• Maroubra Medical Centre — Maroubra, New South Wales, Australia
• Holdsworth House Medical Practice — Sydney, New South Wales, Australia
• Royal Adelaide Hospital — Adelaide, South Australia, Australia
• Western Respiratory Trial Specialists — Spearwood, Western Australia, Australia
• Dr. MARTINOT Jean-Benoît — Erpent, Belgium
• UZ Gent — Ghent, Belgium
• UZ Leuven Gasthuisberg — Leuven, Belgium
• CHU de Liège — Liège, Belgium
• VZW Emmaus — Mechelen, Belgium
• California Allergy & Asthma Medical Group & Research Center — Los Angeles, California, United States

Full record on ClinicalTrials.gov

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