Clinical Study to Evaluate the Efficacy and Safety of Three Different Doses of BAY1817080 Compared to Placebo in Patients With Chronic Cough
Condition: Refractory and/or Unexplained Chronic Cough
MeSH terms: Cough
Intervention: BAY1817080; Placebo
Intervention description: Study drug BAY1817080 will be administered orally as tablet.; Matching Placebo for BAY1817080 will be administered orally as tablet.
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 310.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: RUCC; Chronic cough; P2X3 receptor antagonist

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.
    

Eligibility criteria:

        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.