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

Primary Purpose

Refractory and/or Unexplained Chronic Cough

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
BAY1817080
Placebo
Sponsored by
Bayer
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Refractory and/or Unexplained Chronic Cough focused on measuring RUCC, Chronic cough, P2X3 receptor antagonist

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • California Allergy & Asthma Medical Group & Research Center
  • Florida Pediatrics
  • Chesapeake Clinical Research, Inc.
  • Minnesota Lung Center
  • Montana Medical Research, Inc
  • Vanderbilt University Medical School
  • Pharmaceutical Research & Consulting, Inc.
  • Bellingham Asthma, Allergy & Immunology Clinic
  • Instituto Ave Pulmo
  • Centro Respiratorio Quilmes
  • Centro Médico Dra. De Salvo - Clinical Research Center
  • Centro de Investigaciones Clínicas
  • Fundación CIDEA
  • Investigación en Alergias y Enfermedades Respiratorias-INAER
  • Investigaciones en Patologías Respiratorias
  • Macquarie University Hospital
  • Maroubra Medical Centre
  • Holdsworth House Medical Practice
  • Royal Adelaide Hospital
  • Western Respiratory Trial Specialists
  • Dr. MARTINOT Jean-Benoît
  • UZ Gent
  • UZ Leuven Gasthuisberg
  • CHU de Liège
  • VZW Emmaus
  • Burlington Lung Clinic (BLC) Clinical Research
  • Clinique de pneumologie et du sommeil de Lanaudière (CPSL)
  • MUDr Otakar Hokynar - Plicni ambulance
  • Ordinace pro TBC a respiracni nemoci, s.r.o.
  • Dawon s.r.o.
  • Plicní stredisko Teplice, s.r.o.
  • MUDr. Milan Sklenar
  • Cochin - Paris
  • CHU de Toulouse - Hôpital Larrey
  • Klinikum Konstanz
  • Zentrum f. ambulante pneumologische Forschung Marburg GbR
  • Ballenberger, Freytag, Wenisch
  • Pneumologicum im Südstadt Forum
  • Medizinische Hochschule Hannover (MHH)
  • Priv.-Doz. Dr. med. Christian Gessner
  • Praxis f. Lungen- und Bronchialheilkunde,
  • D.Kenessey A Hospital
  • EKBC, Uj Szent Janos Korhaz es Szakrendelo
  • Erzsebet Gondozohaz
  • Da Vinci Maganklinika
  • Farmakontroll Bt.
  • ASST Lodi
  • A.O.U. Careggi
  • IRCCS Ospedale Sacro Cuore Don Calabria
  • A.O.U.I. Verona
  • Nagoya City University Hospital
  • University of Fukui Hospital
  • University of Occupational and Environmental Health
  • Idaimae Minami Yojo
  • Japan community health care organization Kanazawa Hospital
  • Komatsu Municipal Hospital
  • Yokohama City Minato Red Cross Hospital
  • Saiseikai Yokohamashi Nanbu Hospital
  • Matsusaka Municipal Hospital
  • Hamamatsu Rosai Hospital
  • Tokyo Shinagawa Hospital
  • Fukushima Medical University Hospital
  • Catharina Ziekenhuis
  • Isala
  • Centrum Medycyny Oddechowej Mroz Spolka Jawna
  • KLIMED Marek Klimkiewicz
  • Centrum Alergologii Sp. z o.o.
  • Ostrowieckie Centrum Medyczne Sp. Cyw. A.O-C. K.C.
  • Centrum Medyczne Lucyna Andrzej Dymek
  • Region Clinical Emergency Hospital n.a. M.A.Podgorbunskogo
  • City Clinical Hospital n.a. D.D. Pletnev
  • LLC "Medical Center "SibNovoMed""
  • City Clinical Hospital #4 Samara
  • City Consultative and Diagnostic Center #1
  • LLC Astarta
  • Voronezh Regional Clinical Hospital #1
  • ALIAN s.r.o.
  • INSPIRO, s.r.o.
  • AlergoImunocentrum, s.r.o.
  • Plucna ambulancia s.r.o.
  • Ambulancia klin. imunologie a alergologie, ANA JJ, s.r.o.
  • Hospital Clínico Universitario de Santiago de Compostela
  • Hospital Universitari Germans Trias i Pujol
  • Hospital Clínic i Provincial de Barcelona
  • Chang Gung Memorial Hospital Keelung
  • Far Eastern Memorial Hospital
  • Taichung Veterans General Hospital
  • National Taiwan University Hospital
  • Taipei Medical University Hospital
  • Akdeniz Universitesi Tip Fakultesi Hastanesi
  • Istanbul Universitesi Cerrahpasa-Cerrahpasa Tip Fakultesi
  • Ege Universitesi Tip Fakultesi
  • Sureyyapasa Gogus Hasalikleri. ve Gogus Cerrahisi EAH
  • Mersin Universitesi Tip Fakultesi
  • North Tyneside General Hospital
  • West Walk Surgery
  • Castle Hill Hospital
  • King's College Hospital - NHS Foundation Trust
  • University Hospital of South Manchester

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Placebo Comparator

Arm Label

BAY1817080 dose A BID

BAY1817080 dose B BID

BAY1817080 dose C BID

Placebo

Arm Description

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.

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.

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.

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.

Outcomes

Primary Outcome Measures

Change From Baseline in 24-hour Cough Count After 12 Weeks of Intervention
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

Secondary Outcome Measures

Percentage of Participants With a ≥30% Reduction From Baseline in 24-hour Cough Count After 12 Weeks of Intervention
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
Change From Baseline in 24-hour Cough Count After 2, 4, and 8 Weeks of Intervention
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
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 btw = between geo = geometric
Change From Baseline in Cough Related Quality of Life After 12 Weeks of Intervention
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.
Change From Baseline in Cough Severity After 12 Weeks of Intervention
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".
Percentage of Participants With a ≥30 Scale Units Reduction From Baseline After 12 Weeks of Intervention
Measured by cough Severity VAS
Percentage of Participants With a ≥1.3-point Increase From Baseline After 12 Weeks of Intervention
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.
Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Associated Severity
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.

Full Information

First Posted
September 18, 2020
Last Updated
July 24, 2022
Sponsor
Bayer
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1. Study Identification

Unique Protocol Identification Number
NCT04562155
Brief Title
Clinical Study to Evaluate the Efficacy and Safety of Three Different Doses of BAY1817080 Compared to Placebo in Patients With Chronic Cough
Acronym
PAGANINI
Official 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)
Study Type
Interventional

2. Study Status

Record Verification Date
July 2022
Overall Recruitment Status
Completed
Study Start Date
October 2, 2020 (Actual)
Primary Completion Date
June 22, 2021 (Actual)
Study Completion Date
July 23, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Bayer

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Refractory and/or Unexplained Chronic Cough
Keywords
RUCC, Chronic cough, P2X3 receptor antagonist

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
310 (Actual)

8. Arms, Groups, and Interventions

Arm Title
BAY1817080 dose A BID
Arm Type
Experimental
Arm Description
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.
Arm Title
BAY1817080 dose B BID
Arm Type
Experimental
Arm Description
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.
Arm Title
BAY1817080 dose C BID
Arm Type
Experimental
Arm Description
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.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
BAY1817080
Intervention Description
Study drug BAY1817080 will be administered orally as tablet.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Matching Placebo for BAY1817080 will be administered orally as tablet.
Primary Outcome Measure Information:
Title
Change From Baseline in 24-hour Cough Count After 12 Weeks of Intervention
Description
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
Time Frame
From baseline up to 12 weeks
Secondary Outcome Measure Information:
Title
Percentage of Participants With a ≥30% Reduction From Baseline in 24-hour Cough Count After 12 Weeks of Intervention
Description
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
Time Frame
From baseline up to 12 weeks
Title
Change From Baseline in 24-hour Cough Count After 2, 4, and 8 Weeks of Intervention
Description
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
Time Frame
From baseline up to 2 weeks, 4 weeks and 8 weeks
Title
Change From Baseline in Awake Cough Frequency Per Hour After 2, 4, 8 and 12 Weeks of Intervention
Description
Measured by cough recording digital wearable monitoring device btw = between geo = geometric
Time Frame
From baseline up to 2 weeks, 4 weeks, 8 weeks and 12 weeks
Title
Change From Baseline in Cough Related Quality of Life After 12 Weeks of Intervention
Description
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.
Time Frame
From baseline up to 12 weeks
Title
Change From Baseline in Cough Severity After 12 Weeks of Intervention
Description
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".
Time Frame
From baseline up to 12 weeks
Title
Percentage of Participants With a ≥30 Scale Units Reduction From Baseline After 12 Weeks of Intervention
Description
Measured by cough Severity VAS
Time Frame
From baseline up to 12 weeks
Title
Percentage of Participants With a ≥1.3-point Increase From Baseline After 12 Weeks of Intervention
Description
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.
Time Frame
From baseline up to 12 weeks
Title
Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Associated Severity
Description
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.
Time Frame
From the start of study intervention administration until 14 days after the last study medication intake, with an average of 80.0 + 14 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Facility Information:
Facility Name
California Allergy & Asthma Medical Group & Research Center
City
Los Angeles
State/Province
California
ZIP/Postal Code
90025
Country
United States
Facility Name
Florida Pediatrics
City
Largo
State/Province
Florida
ZIP/Postal Code
33778
Country
United States
Facility Name
Chesapeake Clinical Research, Inc.
City
White Marsh
State/Province
Maryland
ZIP/Postal Code
21162
Country
United States
Facility Name
Minnesota Lung Center
City
Edina
State/Province
Minnesota
ZIP/Postal Code
55435
Country
United States
Facility Name
Montana Medical Research, Inc
City
Missoula
State/Province
Montana
ZIP/Postal Code
59808
Country
United States
Facility Name
Vanderbilt University Medical School
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37212-1610
Country
United States
Facility Name
Pharmaceutical Research & Consulting, Inc.
City
Dallas
State/Province
Texas
ZIP/Postal Code
75231
Country
United States
Facility Name
Bellingham Asthma, Allergy & Immunology Clinic
City
Bellingham
State/Province
Washington
ZIP/Postal Code
98225
Country
United States
Facility Name
Instituto Ave Pulmo
City
Mar del Plata
State/Province
Buenos Aires
Country
Argentina
Facility Name
Centro Respiratorio Quilmes
City
Quilmes
State/Province
Buenos Aires
Country
Argentina
Facility Name
Centro Médico Dra. De Salvo - Clinical Research Center
City
Buenos Aires
State/Province
Ciudad Auton. De Buenos Aires
ZIP/Postal Code
C1426ABP
Country
Argentina
Facility Name
Centro de Investigaciones Clínicas
City
Caba
State/Province
Ciudad Auton. De Buenos Aires
ZIP/Postal Code
C1018DES
Country
Argentina
Facility Name
Fundación CIDEA
City
Caba
State/Province
Ciudad Auton. De Buenos Aires
ZIP/Postal Code
C1121ABE
Country
Argentina
Facility Name
Investigación en Alergias y Enfermedades Respiratorias-INAER
City
Caba
State/Province
Ciudad Auton. De Buenos Aires
ZIP/Postal Code
C1425
Country
Argentina
Facility Name
Investigaciones en Patologías Respiratorias
City
San Miguel de Tucumán
State/Province
Tucuman
Country
Argentina
Facility Name
Macquarie University Hospital
City
Macquarie University
State/Province
New South Wales
ZIP/Postal Code
2109
Country
Australia
Facility Name
Maroubra Medical Centre
City
Maroubra
State/Province
New South Wales
ZIP/Postal Code
2035
Country
Australia
Facility Name
Holdsworth House Medical Practice
City
Sydney
State/Province
New South Wales
ZIP/Postal Code
2010
Country
Australia
Facility Name
Royal Adelaide Hospital
City
Adelaide
State/Province
South Australia
ZIP/Postal Code
5000
Country
Australia
Facility Name
Western Respiratory Trial Specialists
City
Spearwood
State/Province
Western Australia
ZIP/Postal Code
6163
Country
Australia
Facility Name
Dr. MARTINOT Jean-Benoît
City
Erpent
ZIP/Postal Code
5101
Country
Belgium
Facility Name
UZ Gent
City
Gent
ZIP/Postal Code
9000
Country
Belgium
Facility Name
UZ Leuven Gasthuisberg
City
Leuven
ZIP/Postal Code
3000
Country
Belgium
Facility Name
CHU de Liège
City
Liege
ZIP/Postal Code
4000
Country
Belgium
Facility Name
VZW Emmaus
City
Mechelen
ZIP/Postal Code
2800
Country
Belgium
Facility Name
Burlington Lung Clinic (BLC) Clinical Research
City
Burlington
State/Province
Ontario
ZIP/Postal Code
L7N 3V2
Country
Canada
Facility Name
Clinique de pneumologie et du sommeil de Lanaudière (CPSL)
City
St-Charles-Borromée
State/Province
Quebec
ZIP/Postal Code
J6E 2B4
Country
Canada
Facility Name
MUDr Otakar Hokynar - Plicni ambulance
City
Kralupy nad Vltavou
ZIP/Postal Code
278 01
Country
Czechia
Facility Name
Ordinace pro TBC a respiracni nemoci, s.r.o.
City
Olomouc
ZIP/Postal Code
772 00
Country
Czechia
Facility Name
Dawon s.r.o.
City
Praha 4
ZIP/Postal Code
14800
Country
Czechia
Facility Name
Plicní stredisko Teplice, s.r.o.
City
Teplice
ZIP/Postal Code
415 01
Country
Czechia
Facility Name
MUDr. Milan Sklenar
City
Varnsdorf
ZIP/Postal Code
407 47
Country
Czechia
Facility Name
Cochin - Paris
City
Paris
ZIP/Postal Code
75674
Country
France
Facility Name
CHU de Toulouse - Hôpital Larrey
City
TOULOUSE Cedex 9
ZIP/Postal Code
31059
Country
France
Facility Name
Klinikum Konstanz
City
Konstanz
State/Province
Baden-Württemberg
ZIP/Postal Code
78464
Country
Germany
Facility Name
Zentrum f. ambulante pneumologische Forschung Marburg GbR
City
Marburg
State/Province
Hessen
ZIP/Postal Code
35037
Country
Germany
Facility Name
Ballenberger, Freytag, Wenisch
City
Neu-Isenburg
State/Province
Hessen
ZIP/Postal Code
63263
Country
Germany
Facility Name
Pneumologicum im Südstadt Forum
City
Hannover
State/Province
Niedersachsen
ZIP/Postal Code
30173
Country
Germany
Facility Name
Medizinische Hochschule Hannover (MHH)
City
Hannover
State/Province
Niedersachsen
ZIP/Postal Code
30625
Country
Germany
Facility Name
Priv.-Doz. Dr. med. Christian Gessner
City
Leipzig
State/Province
Sachsen
ZIP/Postal Code
04357
Country
Germany
Facility Name
Praxis f. Lungen- und Bronchialheilkunde,
City
Berlin
ZIP/Postal Code
10717
Country
Germany
Facility Name
D.Kenessey A Hospital
City
Balassagyarmat
ZIP/Postal Code
2660
Country
Hungary
Facility Name
EKBC, Uj Szent Janos Korhaz es Szakrendelo
City
Budapest
ZIP/Postal Code
1122
Country
Hungary
Facility Name
Erzsebet Gondozohaz
City
Godollo
ZIP/Postal Code
2100
Country
Hungary
Facility Name
Da Vinci Maganklinika
City
Pecs
ZIP/Postal Code
7635
Country
Hungary
Facility Name
Farmakontroll Bt.
City
Szazhalombatta
ZIP/Postal Code
2440
Country
Hungary
Facility Name
ASST Lodi
City
Lodi
State/Province
Lombardia
ZIP/Postal Code
26845
Country
Italy
Facility Name
A.O.U. Careggi
City
Firenze
State/Province
Toscana
ZIP/Postal Code
50134
Country
Italy
Facility Name
IRCCS Ospedale Sacro Cuore Don Calabria
City
Verona
State/Province
Veneto
ZIP/Postal Code
37024
Country
Italy
Facility Name
A.O.U.I. Verona
City
Verona
State/Province
Veneto
ZIP/Postal Code
37126
Country
Italy
Facility Name
Nagoya City University Hospital
City
Nagoya
State/Province
Aichi
ZIP/Postal Code
467-8602
Country
Japan
Facility Name
University of Fukui Hospital
City
Yoshida
State/Province
Fukui
ZIP/Postal Code
910-1193
Country
Japan
Facility Name
University of Occupational and Environmental Health
City
Kitakyushu
State/Province
Fukuoka
ZIP/Postal Code
807-8556
Country
Japan
Facility Name
Idaimae Minami Yojo
City
Sapporo
State/Province
Hokkaido
ZIP/Postal Code
064-0804
Country
Japan
Facility Name
Japan community health care organization Kanazawa Hospital
City
Kanazawa
State/Province
Ishikawa
ZIP/Postal Code
920-8610
Country
Japan
Facility Name
Komatsu Municipal Hospital
City
Komatsu
State/Province
Ishikawa
ZIP/Postal Code
923-8560
Country
Japan
Facility Name
Yokohama City Minato Red Cross Hospital
City
Yokohama
State/Province
Kanagawa
ZIP/Postal Code
231-8682
Country
Japan
Facility Name
Saiseikai Yokohamashi Nanbu Hospital
City
Yokohama
State/Province
Kanagawa
ZIP/Postal Code
234-8503
Country
Japan
Facility Name
Matsusaka Municipal Hospital
City
Matsusaka
State/Province
Mie
ZIP/Postal Code
515-8544
Country
Japan
Facility Name
Hamamatsu Rosai Hospital
City
Hamamatsu
State/Province
Shizuoka
ZIP/Postal Code
430-8525
Country
Japan
Facility Name
Tokyo Shinagawa Hospital
City
Shinagawa-ku
State/Province
Tokyo
ZIP/Postal Code
140-8522
Country
Japan
Facility Name
Fukushima Medical University Hospital
City
Fukushima
ZIP/Postal Code
960-1295
Country
Japan
Facility Name
Catharina Ziekenhuis
City
Eindhoven
State/Province
Noord-Brabant
ZIP/Postal Code
5623 EJ
Country
Netherlands
Facility Name
Isala
City
Zwolle
ZIP/Postal Code
8025 AB
Country
Netherlands
Facility Name
Centrum Medycyny Oddechowej Mroz Spolka Jawna
City
Bialystok
ZIP/Postal Code
15-044
Country
Poland
Facility Name
KLIMED Marek Klimkiewicz
City
Bychawa
ZIP/Postal Code
23-100
Country
Poland
Facility Name
Centrum Alergologii Sp. z o.o.
City
Lublin
ZIP/Postal Code
20-552
Country
Poland
Facility Name
Ostrowieckie Centrum Medyczne Sp. Cyw. A.O-C. K.C.
City
Ostrowiec Swietokrzyski
ZIP/Postal Code
27-400
Country
Poland
Facility Name
Centrum Medyczne Lucyna Andrzej Dymek
City
Strzelce Opolskie
ZIP/Postal Code
47-100
Country
Poland
Facility Name
Region Clinical Emergency Hospital n.a. M.A.Podgorbunskogo
City
Kemerovo
ZIP/Postal Code
650000
Country
Russian Federation
Facility Name
City Clinical Hospital n.a. D.D. Pletnev
City
Moscow
ZIP/Postal Code
105077
Country
Russian Federation
Facility Name
LLC "Medical Center "SibNovoMed""
City
Novosibirsk
ZIP/Postal Code
630005
Country
Russian Federation
Facility Name
City Clinical Hospital #4 Samara
City
Samara
ZIP/Postal Code
453056
Country
Russian Federation
Facility Name
City Consultative and Diagnostic Center #1
City
St. Petersburg
ZIP/Postal Code
194354
Country
Russian Federation
Facility Name
LLC Astarta
City
St. Petersburg
ZIP/Postal Code
199226
Country
Russian Federation
Facility Name
Voronezh Regional Clinical Hospital #1
City
Voronezh
ZIP/Postal Code
394066
Country
Russian Federation
Facility Name
ALIAN s.r.o.
City
Bardejov
ZIP/Postal Code
085 01
Country
Slovakia
Facility Name
INSPIRO, s.r.o.
City
Humenne
ZIP/Postal Code
066 01
Country
Slovakia
Facility Name
AlergoImunocentrum, s.r.o.
City
Kezmarok
ZIP/Postal Code
060 01
Country
Slovakia
Facility Name
Plucna ambulancia s.r.o.
City
Poprad
ZIP/Postal Code
058 01
Country
Slovakia
Facility Name
Ambulancia klin. imunologie a alergologie, ANA JJ, s.r.o.
City
Topolcany
ZIP/Postal Code
955 01
Country
Slovakia
Facility Name
Hospital Clínico Universitario de Santiago de Compostela
City
Santiago de Compostela
State/Province
A Coruña
ZIP/Postal Code
15706
Country
Spain
Facility Name
Hospital Universitari Germans Trias i Pujol
City
Badalona
State/Province
Barcelona
ZIP/Postal Code
08916
Country
Spain
Facility Name
Hospital Clínic i Provincial de Barcelona
City
Barcelona
ZIP/Postal Code
08036
Country
Spain
Facility Name
Chang Gung Memorial Hospital Keelung
City
Keelung
ZIP/Postal Code
20401
Country
Taiwan
Facility Name
Far Eastern Memorial Hospital
City
New Taipei City
ZIP/Postal Code
220
Country
Taiwan
Facility Name
Taichung Veterans General Hospital
City
Taichung
ZIP/Postal Code
40705
Country
Taiwan
Facility Name
National Taiwan University Hospital
City
Taipei
ZIP/Postal Code
100
Country
Taiwan
Facility Name
Taipei Medical University Hospital
City
Taipei
ZIP/Postal Code
110
Country
Taiwan
Facility Name
Akdeniz Universitesi Tip Fakultesi Hastanesi
City
Antalya
ZIP/Postal Code
07058
Country
Turkey
Facility Name
Istanbul Universitesi Cerrahpasa-Cerrahpasa Tip Fakultesi
City
Istanbul
ZIP/Postal Code
34098
Country
Turkey
Facility Name
Ege Universitesi Tip Fakultesi
City
Izmir
ZIP/Postal Code
35100
Country
Turkey
Facility Name
Sureyyapasa Gogus Hasalikleri. ve Gogus Cerrahisi EAH
City
Maltepe
ZIP/Postal Code
34844
Country
Turkey
Facility Name
Mersin Universitesi Tip Fakultesi
City
Mersin
ZIP/Postal Code
33343
Country
Turkey
Facility Name
North Tyneside General Hospital
City
North Shields
State/Province
Tyne And Wear
ZIP/Postal Code
NE29 8NH
Country
United Kingdom
Facility Name
West Walk Surgery
City
Bristol
ZIP/Postal Code
BS37 4AX
Country
United Kingdom
Facility Name
Castle Hill Hospital
City
Cottingham
ZIP/Postal Code
HU16 5JQ
Country
United Kingdom
Facility Name
King's College Hospital - NHS Foundation Trust
City
London
ZIP/Postal Code
SE5 9RS
Country
United Kingdom
Facility Name
University Hospital of South Manchester
City
Manchester
ZIP/Postal Code
M23 9LT
Country
United Kingdom

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
Availability of this study's data will later be determined according to Bayer's commitment to the EFPIA/PhRMA "Principles for responsible clinical trial data sharing". This pertains to scope, timepoint and process of data access. As such, Bayer commits to sharing upon request from qualified researchers patient-level clinical trial data, study-level clinical trial data, and protocols from clinical trials in patients for medicines and indications approved in the US and EU as necessary for conducting legitimate research. This applies to data on new medicines and indications that have been approved by the EU and US regulatory agencies on or after January 01, 2014. Interested researchers can use www.clinicalstudydatarequest.com to request access to anonymized patient-level data and supporting documents from clinical studies to conduct research. Information on the Bayer criteria for listing studies and other relevant information is provided in the Study sponsors section of the portal.
Citations:
PubMed Identifier
34978027
Citation
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.
Results Reference
background
Links:
URL
https://clinicaltrials.bayer.com/
Description
Click here to find results for studies related to Bayer products
URL
http://www.clinicaltrialsregister.eu/
Description
Click here to find information about studies related to Bayer Healthcare products conducted in Europe

Learn more about this trial

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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