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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT04562155




Registration number
NCT04562155
Ethics application status
Date submitted
18/09/2020
Date registered
24/09/2020
Date last updated
22/04/2021

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
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)
Secondary ID [1] 0 0
2019-004169-42
Secondary ID [2] 0 0
20393
Universal Trial Number (UTN)
Trial acronym
PAGANINI
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Refractory and/or Unexplained Chronic Cough 0 0
Condition category
Condition code
Respiratory 0 0 0 0
Other respiratory disorders / diseases

Intervention/exposure
Study type
Interventional
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.

Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Change from baseline in 24-hour cough count (measured by cough recording digital wearable monitoring device) after 12 weeks of intervention
Timepoint [1] 0 0
From baseline up to 12 weeks
Secondary outcome [1] 0 0
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)
Timepoint [1] 0 0
From baseline up to 12 weeks
Secondary outcome [2] 0 0
Change from baseline in 24-hour cough count after 2, 4, and 8 weeks of intervention (measured by cough recording digital wearable monitoring device)
Timepoint [2] 0 0
From baseline up to 2 weeks, 4 weeks and 8 weeks
Secondary outcome [3] 0 0
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)
Timepoint [3] 0 0
From baseline up to 2 weeks, 4 weeks, 8 weeks and 12 weeks
Secondary outcome [4] 0 0
Change from baseline in cough related quality of life (measured by Leicester Cough Questionnaire [LCQ]) after 12 weeks of intervention
Timepoint [4] 0 0
From baseline up to 12 weeks
Secondary outcome [5] 0 0
Change from baseline in cough severity after 12 weeks of intervention (measured by Cough Severity Visual Analogue Scale [VAS])
Timepoint [5] 0 0
From baseline up to 12 weeks
Secondary outcome [6] 0 0
Percentage of participants with a =30 scale units reduction from baseline after 12 weeks of intervention (measured by cough Severity VAS)
Timepoint [6] 0 0
From baseline up to 12 weeks
Secondary outcome [7] 0 0
Percentage of participants with a =1.3-point increase from baseline after 12 weeks of intervention (measured with LCQ Total Score)
Timepoint [7] 0 0
From baseline up to 12 weeks
Secondary outcome [8] 0 0
Frequency and associated severity of treatment-emergent adverse events (TEAEs)
Timepoint [8] 0 0
From the start of study intervention administration until 14 days after the last study medication intake

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.
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,SA,WA
Recruitment hospital [1] 0 0
Macquarie University Hospital - Macquarie University
Recruitment hospital [2] 0 0
Maroubra Medical Centre - Maroubra
Recruitment hospital [3] 0 0
Holdsworth House Medical Practice - Sydney
Recruitment hospital [4] 0 0
Royal Adelaide Hospital - Adelaide
Recruitment hospital [5] 0 0
Western Respiratory Trial Specialists - Spearwood
Recruitment postcode(s) [1] 0 0
2109 - Macquarie University
Recruitment postcode(s) [2] 0 0
2035 - Maroubra
Recruitment postcode(s) [3] 0 0
2010 - Sydney
Recruitment postcode(s) [4] 0 0
5000 - Adelaide
Recruitment postcode(s) [5] 0 0
6163 - Spearwood
Recruitment outside Australia
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California
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Florida
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Maryland
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Minnesota
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Montana
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Tennessee
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Texas
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Washington
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Argentina
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Buenos Aires
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Ciudad Auton. De Buenos Aires
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Tucuman
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Ontario
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Quebec
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Czechia
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Kralupy nad Vltavou
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Czechia
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Olomouc
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Czechia
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Praha 4
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Teplice
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Varnsdorf
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France
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Paris
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France
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TOULOUSE Cedex 9
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Germany
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Baden-Württemberg
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Germany
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Hessen
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Germany
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Niedersachsen
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Sachsen-Anhalt
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Germany
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Sachsen
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Germany
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Berlin
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Mie
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Samara
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St. Petersburg
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Russian Federation
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Voronezh
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Slovakia
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Bardejov
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Slovakia
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Humenne
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Kezmarok
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Poprad
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Topolcany
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Spain
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A Coruña
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Barcelona
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Taiwan
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Keelung
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New Taipei City
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Taichung
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Taiwan
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Taipei
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Turkey
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Ankara
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Antalya
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Erzurum
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Istanbul
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Izmir
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Maltepe
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Turkey
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Mersin
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United Kingdom
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Tyne And Wear
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United Kingdom
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Bristol
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Cottingham
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London
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United Kingdom
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Manchester

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Bayer
Address
Country

Ethics approval
Ethics application status

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.
Trial website
https://clinicaltrials.gov/show/NCT04562155
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
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Fax 0 0
Email 0 0
Contact person for scientific queries

Summary results
Other publications