Assess the efficacy of BAY1817080 as compared with placebo in terms of change in 24-hour cough count from baseline to week 12. Further assess the efficacy, safety and tolerability profile of BAY1817080 in patients with RCC
ID
Source
Brief title
Condition
- Bronchial disorders (excl neoplasms)
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Change from baseline in 24-hour cough count (measured by cough recording
digital wearable monitoring device) after 12 weeks of intervention
Secondary outcome
1. Percentage of participants with a *30% reduction from baseline in
24-hour cough count after 12 weeks of intervention (measured by cough
recording digital wearable monitoring device)
2. Change from baseline in 24-hour cough count after 2, 4, and 8 weeks
of intervention (measured by cough recording digital wearable
monitoring device)
3. Change from baseline in awake cough frequency per hour after 2, 4, 8
and 12 weeks of intervention (measured by cough recording digital
wearable monitoring device)
4. Change from baseline in cough related quality of life (measured by
Leicester Cough Questionnaire [LCQ]) after 12 weeks of intervention
5. Change from baseline in cough severity after 12 weeks of intervention
(measured by Cough Severity Visual Analogue Scale [VAS])
6. Percentage of participants with a *30 scale units reduction from
baseline after 12 weeks of intervention (measured by cough Severity
VAS)
7. Percentage of participants with a *1.3-point increase from baseline
after 12 weeks of intervention (measured with LCQ Total Score)
8.Frequency and associated severity of treatment-emergent adverse events
(TEAEs)
Background 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.
Study objective
Assess the efficacy of BAY1817080 as compared with placebo in terms of change
in 24-hour cough count from baseline to week 12. Further assess the efficacy,
safety and tolerability profile of BAY1817080 in patients with RCC
Study design
Randomized, double-blind, parallel group, Phase 2b dose-finding, efficacy and
safety study of 12-week twice daily oral administration of BAY 1817080 compared
to placebo in patients with RUCC.
Study duration: approximately 18 weeks
screenings period: approx. 2 weeks
intervention duration: 12 weeks
safety follow up period
Intervention
Experimental: BAY1817080
- 150 mg BID--Study drug BAY1817080 will be administered orally as tablet.
- 75 mg BID--Study drug BAY1817080 will be administered orally as tablet.
-25mg BID--Study drug BAY1817080 will be administered orally as tablet.
- Placebo comparator: placebo BID--Matching Placebo for BAY1817080 will be
administered orally as tablet.
Each participant will be randomized to receive one of three oral doses of BAY
1817080 or placebo, administered twice daily over the course of 12 weeks.
Study burden and risks
NA
Energieweg 1
Mijdrecht 3641RT
NL
Energieweg 1
Mijdrecht 3641RT
NL
Listed location countries
Age
Inclusion criteria
1. Adults * 18 years of age at the time of signing the informed consent.
2. A cough that has lasted for at least 12 months with persistently bothersome
refractory (unresponsive to treatment options) or idiopathic (unexplained)
chronic cough.
3. persistent cough for at least 8 weeks before screening.
4. 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.
5. Capable of giving signed informed consent.
Exclusion criteria
1. 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.
2. 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.
3. Respiratory tract infection within 4 weeks before screening.
4. History of chronic bronchitis.
5.Systolic blood pressure * 160 mmHg and/or diastolic blood pressure * 100 mmHg
at screening visit.
6. Positive SARS-CoV-2 virus RNA and/or serology IgG tests at screening visit.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| EudraCT | EUCTR2019-004169-42-NL |
| CCMO | NL72426.075.20 |