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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT04562155
Registration number
NCT04562155
Ethics application status
Date submitted
18/09/2020
Date registered
24/09/2020
Date last updated
18/08/2022
Titles & IDs
Public title
Clinical Study to Evaluate the Efficacy and Safety of Three Different Doses of BAY1817080 Compared to Placebo in Patients With Chronic Cough
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Scientific title
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 the Treatment of Refractory and/or Unexplained Chronic Cough (RUCC)
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Secondary ID [1]
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2019-004169-42
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Secondary ID [2]
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20393
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Universal Trial Number (UTN)
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Trial acronym
PAGANINI
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Refractory and/or Unexplained Chronic Cough
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Condition category
Condition code
Respiratory
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Other respiratory disorders / diseases
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - BAY1817080
Treatment: Drugs - Placebo
Experimental: BAY1817080 dose A BID - 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.
Experimental: BAY1817080 dose B BID - 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.
Experimental: BAY1817080 dose C BID - 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.
Placebo Comparator: Placebo - 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.
Treatment: Drugs: BAY1817080
Study drug BAY1817080 will be administered orally as tablet.
Treatment: Drugs: Placebo
Matching Placebo for BAY1817080 will be administered orally as tablet.
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Change From Baseline in 24-hour Cough Count After 12 Weeks of Intervention
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Assessment method [1]
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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
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Timepoint [1]
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From baseline up to 12 weeks
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Secondary outcome [1]
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Percentage of Participants With a =30% Reduction From Baseline in 24-hour Cough Count After 12 Weeks of Intervention
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Assessment method [1]
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The raw 24-hour cough count measured by cough recording digital wearable monitoring device was standardized to an average hourly count. The change from baseline in 24-hour cough count was calculated by the geometric mean of 24-hour cough count after 12 weeks of intervention minus the geometric mean at baseline divided by the geometric mean at baseline. The percentage of participants with a reduction of =30% is shown
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Timepoint [1]
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From baseline up to 12 weeks
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Secondary outcome [2]
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Change From Baseline in 24-hour Cough Count After 2, 4, and 8 Weeks of Intervention
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Assessment method [2]
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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 2, 4, and 8 weeks of intervention was divided by the geometric mean of 24-hour cough count at baseline.
btw = between geo = geometric
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Timepoint [2]
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From baseline up to 2 weeks, 4 weeks and 8 weeks
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Secondary outcome [3]
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Change From Baseline in Awake Cough Frequency Per Hour After 2, 4, 8 and 12 Weeks of Intervention
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Assessment method [3]
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Measured by cough recording digital wearable monitoring device
btw = between geo = geometric
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Timepoint [3]
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From baseline up to 2 weeks, 4 weeks, 8 weeks and 12 weeks
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Secondary outcome [4]
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Change From Baseline in Cough Related Quality of Life After 12 Weeks of Intervention
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Assessment method [4]
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Measured by Leicester Cough Questionnaire (LCQ) total score. The LCQ was a 19-item instrument that asked about the impact of chronic cough on various aspects of participants' lives using a recall period of two weeks. The 8 items: 1, 2, 3, 9, 10, 11, 14, 15 built the physical domain. 7 items: 4, 5, 6, 12, 13, 16, 17 built the psychological domain. Further 4 items: 7, 8, 18 and 19 built the social domain. Study participants responded to the items using a 7-point Likert scale from 1 (all of the time) to 7 (none of the time) and entered their assessments on a tablet device. Completion of the LCQ took approximately five minutes. The LCQ total score was calculated as a mean score for each of the three domains ranging from 1 to 7, with the LCQ total score ranging from 3 to 21.
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Timepoint [4]
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From baseline up to 12 weeks
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Secondary outcome [5]
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Change From Baseline in Cough Severity After 12 Weeks of Intervention
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Assessment method [5]
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Measured by Cough Severity Visual Analogue Scale (VAS). The Cough Severity VAS was a single item instrument, asking the study participant to assess the severity of his/her cough using a 0-100 VAS.
This was a vertically oriented line ordered from 0-100, with 0 = "No Cough" and 100 = "Extremely Severe Cough".
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Timepoint [5]
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From baseline up to 12 weeks
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Secondary outcome [6]
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Percentage of Participants With a =30 Scale Units Reduction From Baseline After 12 Weeks of Intervention
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Assessment method [6]
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Measured by cough Severity VAS
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Timepoint [6]
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From baseline up to 12 weeks
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Secondary outcome [7]
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Percentage of Participants With a =1.3-point Increase From Baseline After 12 Weeks of Intervention
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Assessment method [7]
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Measured by LCQ total score. The LCQ was a 19-item instrument that asked about the impact of chronic cough on various aspects of participants' lives using a recall period of two weeks. The 8 items: 1, 2, 3, 9, 10, 11, 14, 15 built the physical domain. 7 items: 4, 5, 6, 12, 13, 16, 17 built the psychological domain. Further 4 items: 7, 8, 18 and 19 built the social domain. Study participants responded to the items using a 7-point Likert scale from 1 (all of the time) to 7 (none of the time) and entered their assessments on a tablet device. Completion of the LCQ took approximately five minutes. The LCQ total score was calculated as a mean score for each of the three domains ranging from 1 to 7, with the LCQ total score ranging from 3 to 21. The percentage of participants with a >= 1.3-point increase in LCQ total score is shown.
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Timepoint [7]
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From baseline up to 12 weeks
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Secondary outcome [8]
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Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Associated Severity
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Assessment method [8]
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Adverse event (AE) was defined as any untoward medical occurrence in a study participant, whether or not considered related to the study intervention, occurring from the time of signing the informed consent until the follow-up visit.
TEAE was defined as any event occurring or worsening after the start of study intervention administration until 14 days after the last intake of study intervention.
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Timepoint [8]
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From the start of study intervention administration until 14 days after the last study medication intake, with an average of 80.0 + 14 days
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Eligibility
Key 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.
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key 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.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people analysing the results/data
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 2
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
2/10/2020
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
23/07/2021
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Sample size
Target
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Accrual to date
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Final
310
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Recruitment in Australia
Recruitment state(s)
NSW,SA,WA
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Recruitment hospital [1]
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Macquarie University Hospital - Macquarie University
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Maroubra Medical Centre - Maroubra
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Holdsworth House Medical Practice - Sydney
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Royal Adelaide Hospital - Adelaide
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Western Respiratory Trial Specialists - Spearwood
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2109 - Macquarie University
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2035 - Maroubra
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2010 - Sydney
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5000 - Adelaide
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6163 - Spearwood
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Recruitment outside Australia
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Manchester
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
Bayer
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Ethics approval
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Summary
Brief 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.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT04562155
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Trial related presentations / publications
Fletcher MC. Selectivity of the P2X3 receptor antagonist Eliapixant, and its potential use in the treatment of endometriosis. Purinergic Signal. 2022 Mar;18(1):1-3. doi: 10.1007/s11302-021-09831-5. Epub 2022 Jan 3. No abstract available.
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Public notes
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Contacts
Principal investigator
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT04562155
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