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Evaluation of the Efficacy and Safety of BLU-5937 in Adults With Refractory Chronic Cough (SOOTHE)

Primary Purpose

Refractory Chronic Cough

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
BLU-5937
Placebo
Sponsored by
Bellus Health Inc
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Refractory Chronic Cough focused on measuring BLU-5937, Refractory Chronic Cough, P2X3 receptor antagonist

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Capable of giving signed informed consent
  • Refractory chronic cough (including unexplained chronic cough) for at least one year
  • Women of child-bearing potential must use a highly effective contraception method during the study and for at least 14 days after the last dose

Exclusion Criteria:

  • Current smoker/vaper (all forms of smoking and inhaled substances, including , cannabis/tobacco smoke and nicotine vapors) or individuals who have given up smoking within the past 6 months, or those with >20 pack-year smoking history
  • Diagnosis of Chronic Obstructive Pulmonary Disease (COPD), bronchiectasis, idiopathic pulmonary fibrosis or uncontrolled asthma
  • Respiratory tract infection within 4 weeks before screening
  • Laboratory confirmed Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) infection at screening
  • History of malignancy in the last 5 years
  • History of alcohol or drug abuse within the last 3 years
  • Has a positive serologic test for human immunodeficiency virus (HIV), hepatitis B virus surface antigen, or hepatitis C virus.
  • Previous participation in a BLU-5937 trial

Sites / Locations

  • Phoenix Medical Research Inc
  • Little Rock Allergy and Asthma Clinical Research Center
  • Southern California Institute For Respiratory Diseases, Inc
  • Allergy and Asthma Associates of Southern California
  • California Medical Research Associates, Inc.
  • Allergy Associates Medical Group Inc.
  • Allergy and Asthma Associates of Santa Clara Valley Research Center
  • Colorado Allergy and Asthma Centers
  • St. Francis Medical Institute
  • Floridian Clinical Research
  • Sweet Hope Research Specialty, Inc.
  • Sher Allergy Specialist/Center for Cough
  • Medical Research of Central Florida
  • ProCare Clinical Research
  • Central Florida Pulmonary Group PA
  • Lenus Research & Medical Group
  • IACT Health - Columbus
  • IACT Health - Lawrenceville
  • IACT Health - Rincon
  • Sneeze Wheeze and Itch Associates LLC
  • AES - Synexus Clinical Research US, Inc. - Evansville
  • Abraham Research PLLC
  • Infinity Medical Research Inc
  • Minnesota Lung Center
  • Mayo Clinic
  • Minnesota Lung Center
  • The Lung Research Center, LLC
  • University of Missouri, ENT and Allergy Center of Missouri
  • The Clinical Research Center LLC
  • Montana Medical Research
  • Creighton University Medical Center
  • Atlantic Respiratory Institute
  • Albuquerque Clinical Trials Inc
  • CHEAR Center LLC
  • American Health Research Inc
  • Clinical Research of Gastonia
  • Southeastern Research Center
  • Bernstein Clinical Research Center Inc
  • The Cleveland Clinic Foundation
  • Remington Davis Inc
  • Vital Prospects Clinical Research Institute PC
  • Clinical Research Associates Of Central Pa
  • Synexus Clinical Research US, Inc.
  • National Allergy and Asthma Research
  • Clinical Research of Rock Hill
  • Clinical Trials Center of Middle Tennessee
  • Pharmaceutical Research & Consulting Inc
  • El Paso Pulmonary Association
  • Village Research, LLC
  • Metroplex Pulmonary and Sleep Medicine Center
  • Diagnostics Research Group
  • Sherman Clinical Research
  • Allergy Asthma Research Institute
  • Intermountain Clinical Research
  • TPMG Lung & Sleep Specialist
  • McMaster University Medical Centre
  • Diex Recherche - Québec
  • Clinique Spécialisée en Allergie de la Capitale
  • Inspiration Research Limited
  • C I C Maurice Inc
  • Diex Recherche - Victoriaville
  • MUDr. I. Cierná Peterová s.r.o.
  • Pneumologie Varnsdorf S.r.o.
  • Plicní ambulance Rokycany s.r.o.
  • Synexus Czech s.r.o.
  • MediTrial s.r.o.
  • MUDr. Jaroslav Mares - odborny lekar pro obor tuberkulosa a respiracni nemoci
  • Plicni stredisko Teplice s.r.o.
  • Thoraxklinik-Heidelberg gGmbH
  • Synexus Frankfurt Research Centre
  • IKF Pneumologie
  • Zentrum für ambulante pneumologische Forschung Marburg GbR
  • Ballenberger. Freytag. Wenisch - Institut fuer klinische Forschung GmbH
  • Kfns Klinische Forschung Schwerin
  • Universitätsklinikum Bonn
  • Klinische Forschung Dresden GmbH (KFGN)
  • Synexus Leipzig Research Centre
  • Ärztezentrum Axel Springer Passage
  • Da Vinci Maganklinika
  • Synexus Gyula - Magyarország Egészségügyi Szolgáltató Kft
  • Szent Borbála Kórház
  • Dr. Kenessey Albert Korhaz-Rendelointezet
  • Synexus Zalaegerszeg Magyarország Egészségügyi Kft
  • Synexus Budapest - Magyarország Egészségügyi Szolgáltató Kft
  • Osrodek Badan Klinicznych CLINSANTE S.C. Ewa Galczak-Nowak Malgorzata Trzaska
  • Medical Center Kermed
  • Centrum Medyczne Bydgoszcz - PRATIA
  • Synexus Polska Sp. Z o.o Oddzial w Lodzi
  • KLIMED
  • Clinical Best Solutions -Lublin
  • Centrum Alergologii Specjalistyczna Przychodnia Alergologiczna
  • Centrum Medyczne Warszawa - PRATIA
  • Alergo-Med Specjalistyczna Przychodnia Lekarska Sp. z.o.o
  • Prywatny Gabinet Internistyczno-Alergologiczny
  • Synexus Polska Sp. z o.o. Oddzial w Gdansku
  • Centrum Medyczne Wos i Piwowarczyk
  • Synexus Polska Sp. z o.o. Oddzial w Czestochowie
  • Ostrowieckie Centrum Medyczne Spólka Cywilna Anna Olech-Cudzik, Krzysztof Cudzik
  • Synexus Midlands Clinical Research Centre
  • West Walk Surgery
  • MeDiNova Northamptonshire Quality Research Site
  • Castle Hill Hospital
  • MeDiNova Warwickshire Quality Research Site
  • Kings College Hospital
  • Royal Brompton Hospital
  • NW Consortium Manchester
  • Wythenshawe Hospital - PPDS
  • MeDiNova North London Quality Research Site
  • North Tyneside General Hospital
  • MeDiNova East London Quality Research Site
  • MeDiNova Yorkshire Quality Research Site
  • MeDiNova South London Quality Research Site
  • MeDiNova West London Quality Research Site
  • Ormeau Clinical Trials Limited
  • Belfast City Hospital
  • AES - Synexus Scotland Clinical Research Centre

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm Type

Experimental

Experimental

Experimental

Placebo Comparator

Experimental

Placebo Comparator

Arm Label

BLU-5937 Dose A

BLU-5937 Dose B

BLU-5937 Dose C

Placebo

BLU-5937 Dose A (Population with baseline cough < 25 coughs/hour)

Placebo (Population with baseline cough < 25 coughs/hour)

Arm Description

BLU-5937 oral dose A twice a day.

BLU-5937 oral dose B twice a day.

BLU-5937 oral dose C twice a day.

Matching Placebo for BLU-5937 oral dose twice a day.

BLU-5937 oral dose A twice a day.

Matching Placebo for BLU-5937 oral dose twice a day.

Outcomes

Primary Outcome Measures

Change from baseline in the 24-hour cough frequency
Assessed using an ambulatory cough monitor

Secondary Outcome Measures

Percentage of Participants with a Reduction from Baseline in the 24-hour Cough Frequency by ≥ 30%, 50% and 70%
Assessed using an ambulatory cough monitor
Change from Baseline in Leicester Cough Questionnaire (LCQ)
The LCQ is a patient-reported quality of life (QOL) measure of chronic cough. The questionnaire consists of 19 items to which the patient responds on a 7-point Likert response scale (from 1 to 7). Each item assesses symptoms during cough and the effect of cough on 3 main domains: physical, psychological and social. Domain scores range from 1-7, and the total score ranges from 3 - 21; a higher score indicates a better quality of life.
Change from baseline in cough severity
Assessed by Cough Severity Visual Analogue Scale [VAS] by the participant on a 100 mm visual analog scale where higher scores indicate worse severity.
Incidence (% of subjects) of treatment-emergent adverse events (TEAEs)
Severity (mild, moderate, or severe) of treatment-emergent adverse events (TEAEs)

Full Information

First Posted
December 9, 2020
Last Updated
December 10, 2021
Sponsor
Bellus Health Inc
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1. Study Identification

Unique Protocol Identification Number
NCT04678206
Brief Title
Evaluation of the Efficacy and Safety of BLU-5937 in Adults With Refractory Chronic Cough
Acronym
SOOTHE
Official Title
A Randomized, Adaptive, Double-Blind, Placebo-Controlled, Parallel-Arm, Phase 2b Study to Evaluate the Efficacy and Safety of Multiple Doses of BLU-5937 in Adult Participants With Refractory Chronic Cough
Study Type
Interventional

2. Study Status

Record Verification Date
December 2021
Overall Recruitment Status
Completed
Study Start Date
December 7, 2020 (Actual)
Primary Completion Date
October 21, 2021 (Actual)
Study Completion Date
November 2, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Bellus Health Inc

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
This is a randomized, double-blind, placebo-controlled, parallel-arm, Phase 2b adaptive dose-finding study of BLU-5937 in participants with Refractory Chronic Cough (RCC).
Detailed Description
The primary objective of this study is to determine the therapeutic dose of BLU-5937 in patients with refractory chronic cough by assessing the change from baseline to week 4 in the 24-hour cough frequency with BLU-5937 relative to placebo.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Refractory Chronic Cough
Keywords
BLU-5937, Refractory Chronic Cough, P2X3 receptor antagonist

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Model Description
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
310 (Actual)

8. Arms, Groups, and Interventions

Arm Title
BLU-5937 Dose A
Arm Type
Experimental
Arm Description
BLU-5937 oral dose A twice a day.
Arm Title
BLU-5937 Dose B
Arm Type
Experimental
Arm Description
BLU-5937 oral dose B twice a day.
Arm Title
BLU-5937 Dose C
Arm Type
Experimental
Arm Description
BLU-5937 oral dose C twice a day.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Matching Placebo for BLU-5937 oral dose twice a day.
Arm Title
BLU-5937 Dose A (Population with baseline cough < 25 coughs/hour)
Arm Type
Experimental
Arm Description
BLU-5937 oral dose A twice a day.
Arm Title
Placebo (Population with baseline cough < 25 coughs/hour)
Arm Type
Placebo Comparator
Arm Description
Matching Placebo for BLU-5937 oral dose twice a day.
Intervention Type
Drug
Intervention Name(s)
BLU-5937
Intervention Description
Oral administration of BLU-5937 Tablets
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Oral administration of matching placebo for BLU-5937 Tablets
Primary Outcome Measure Information:
Title
Change from baseline in the 24-hour cough frequency
Description
Assessed using an ambulatory cough monitor
Time Frame
Week 4
Secondary Outcome Measure Information:
Title
Percentage of Participants with a Reduction from Baseline in the 24-hour Cough Frequency by ≥ 30%, 50% and 70%
Description
Assessed using an ambulatory cough monitor
Time Frame
Week 4
Title
Change from Baseline in Leicester Cough Questionnaire (LCQ)
Description
The LCQ is a patient-reported quality of life (QOL) measure of chronic cough. The questionnaire consists of 19 items to which the patient responds on a 7-point Likert response scale (from 1 to 7). Each item assesses symptoms during cough and the effect of cough on 3 main domains: physical, psychological and social. Domain scores range from 1-7, and the total score ranges from 3 - 21; a higher score indicates a better quality of life.
Time Frame
Week 4
Title
Change from baseline in cough severity
Description
Assessed by Cough Severity Visual Analogue Scale [VAS] by the participant on a 100 mm visual analog scale where higher scores indicate worse severity.
Time Frame
Week 4
Title
Incidence (% of subjects) of treatment-emergent adverse events (TEAEs)
Time Frame
2 Weeks after the last study medication intake
Title
Severity (mild, moderate, or severe) of treatment-emergent adverse events (TEAEs)
Time Frame
2 Weeks after the last study medication intake

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Capable of giving signed informed consent Refractory chronic cough (including unexplained chronic cough) for at least one year Women of child-bearing potential must use a highly effective contraception method during the study and for at least 14 days after the last dose Exclusion Criteria: Current smoker/vaper (all forms of smoking and inhaled substances, including , cannabis/tobacco smoke and nicotine vapors) or individuals who have given up smoking within the past 6 months, or those with >20 pack-year smoking history Diagnosis of Chronic Obstructive Pulmonary Disease (COPD), bronchiectasis, idiopathic pulmonary fibrosis or uncontrolled asthma Respiratory tract infection within 4 weeks before screening Laboratory confirmed Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) infection at screening History of malignancy in the last 5 years History of alcohol or drug abuse within the last 3 years Has a positive serologic test for human immunodeficiency virus (HIV), hepatitis B virus surface antigen, or hepatitis C virus. Previous participation in a BLU-5937 trial
Facility Information:
Facility Name
Phoenix Medical Research Inc
City
Peoria
State/Province
Arizona
ZIP/Postal Code
85381
Country
United States
Facility Name
Little Rock Allergy and Asthma Clinical Research Center
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
21237
Country
United States
Facility Name
Southern California Institute For Respiratory Diseases, Inc
City
Los Angeles
State/Province
California
ZIP/Postal Code
90048
Country
United States
Facility Name
Allergy and Asthma Associates of Southern California
City
Mission Viejo
State/Province
California
ZIP/Postal Code
92691
Country
United States
Facility Name
California Medical Research Associates, Inc.
City
Northridge
State/Province
California
ZIP/Postal Code
91324
Country
United States
Facility Name
Allergy Associates Medical Group Inc.
City
San Diego
State/Province
California
ZIP/Postal Code
92120
Country
United States
Facility Name
Allergy and Asthma Associates of Santa Clara Valley Research Center
City
San Jose
State/Province
California
ZIP/Postal Code
95117
Country
United States
Facility Name
Colorado Allergy and Asthma Centers
City
Denver
State/Province
Colorado
ZIP/Postal Code
80230
Country
United States
Facility Name
St. Francis Medical Institute
City
Clearwater
State/Province
Florida
ZIP/Postal Code
33765
Country
United States
Facility Name
Floridian Clinical Research
City
Hialeah
State/Province
Florida
ZIP/Postal Code
33016
Country
United States
Facility Name
Sweet Hope Research Specialty, Inc.
City
Hialeah
State/Province
Florida
ZIP/Postal Code
33016
Country
United States
Facility Name
Sher Allergy Specialist/Center for Cough
City
Largo
State/Province
Florida
ZIP/Postal Code
33778
Country
United States
Facility Name
Medical Research of Central Florida
City
Leesburg
State/Province
Florida
ZIP/Postal Code
34748
Country
United States
Facility Name
ProCare Clinical Research
City
Miami Lakes
State/Province
Florida
ZIP/Postal Code
33014
Country
United States
Facility Name
Central Florida Pulmonary Group PA
City
Orlando
State/Province
Florida
ZIP/Postal Code
32803
Country
United States
Facility Name
Lenus Research & Medical Group
City
Sweetwater
State/Province
Florida
ZIP/Postal Code
33172
Country
United States
Facility Name
IACT Health - Columbus
City
Columbus
State/Province
Georgia
ZIP/Postal Code
31904
Country
United States
Facility Name
IACT Health - Lawrenceville
City
Lawrenceville
State/Province
Georgia
ZIP/Postal Code
30046
Country
United States
Facility Name
IACT Health - Rincon
City
Rincon
State/Province
Georgia
ZIP/Postal Code
31326
Country
United States
Facility Name
Sneeze Wheeze and Itch Associates LLC
City
Normal
State/Province
Illinois
ZIP/Postal Code
61761
Country
United States
Facility Name
AES - Synexus Clinical Research US, Inc. - Evansville
City
Evansville
State/Province
Indiana
ZIP/Postal Code
47714
Country
United States
Facility Name
Abraham Research PLLC
City
Fort Mitchell
State/Province
Kentucky
ZIP/Postal Code
41017
Country
United States
Facility Name
Infinity Medical Research Inc
City
North Dartmouth
State/Province
Massachusetts
ZIP/Postal Code
02747
Country
United States
Facility Name
Minnesota Lung Center
City
Edina
State/Province
Minnesota
ZIP/Postal Code
55435
Country
United States
Facility Name
Mayo Clinic
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
Facility Name
Minnesota Lung Center
City
Woodbury
State/Province
Minnesota
ZIP/Postal Code
55125
Country
United States
Facility Name
The Lung Research Center, LLC
City
Chesterfield
State/Province
Missouri
ZIP/Postal Code
63017
Country
United States
Facility Name
University of Missouri, ENT and Allergy Center of Missouri
City
Columbia
State/Province
Missouri
ZIP/Postal Code
65201
Country
United States
Facility Name
The Clinical Research Center LLC
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63141
Country
United States
Facility Name
Montana Medical Research
City
Missoula
State/Province
Montana
ZIP/Postal Code
59808
Country
United States
Facility Name
Creighton University Medical Center
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68124
Country
United States
Facility Name
Atlantic Respiratory Institute
City
Summit
State/Province
New Jersey
ZIP/Postal Code
07901
Country
United States
Facility Name
Albuquerque Clinical Trials Inc
City
Albuquerque
State/Province
New Mexico
ZIP/Postal Code
87102
Country
United States
Facility Name
CHEAR Center LLC
City
Bronx
State/Province
New York
ZIP/Postal Code
10455
Country
United States
Facility Name
American Health Research Inc
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28277
Country
United States
Facility Name
Clinical Research of Gastonia
City
Gastonia
State/Province
North Carolina
ZIP/Postal Code
28054
Country
United States
Facility Name
Southeastern Research Center
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27103
Country
United States
Facility Name
Bernstein Clinical Research Center Inc
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45231
Country
United States
Facility Name
The Cleveland Clinic Foundation
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
Facility Name
Remington Davis Inc
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43215
Country
United States
Facility Name
Vital Prospects Clinical Research Institute PC
City
Tulsa
State/Province
Oklahoma
ZIP/Postal Code
74136
Country
United States
Facility Name
Clinical Research Associates Of Central Pa
City
Altoona
State/Province
Pennsylvania
ZIP/Postal Code
16601
Country
United States
Facility Name
Synexus Clinical Research US, Inc.
City
Anderson
State/Province
South Carolina
ZIP/Postal Code
29621
Country
United States
Facility Name
National Allergy and Asthma Research
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29420
Country
United States
Facility Name
Clinical Research of Rock Hill
City
Rock Hill
State/Province
South Carolina
ZIP/Postal Code
29732
Country
United States
Facility Name
Clinical Trials Center of Middle Tennessee
City
Franklin
State/Province
Tennessee
ZIP/Postal Code
37067
Country
United States
Facility Name
Pharmaceutical Research & Consulting Inc
City
Dallas
State/Province
Texas
ZIP/Postal Code
75231
Country
United States
Facility Name
El Paso Pulmonary Association
City
El Paso
State/Province
Texas
ZIP/Postal Code
79902
Country
United States
Facility Name
Village Research, LLC
City
Houston
State/Province
Texas
ZIP/Postal Code
77084
Country
United States
Facility Name
Metroplex Pulmonary and Sleep Medicine Center
City
McKinney
State/Province
Texas
ZIP/Postal Code
75069
Country
United States
Facility Name
Diagnostics Research Group
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
Sherman Clinical Research
City
Sherman
State/Province
Texas
ZIP/Postal Code
75092
Country
United States
Facility Name
Allergy Asthma Research Institute
City
Waco
State/Province
Texas
ZIP/Postal Code
76712
Country
United States
Facility Name
Intermountain Clinical Research
City
Draper
State/Province
Utah
ZIP/Postal Code
84020
Country
United States
Facility Name
TPMG Lung & Sleep Specialist
City
Williamsburg
State/Province
Virginia
ZIP/Postal Code
23188
Country
United States
Facility Name
McMaster University Medical Centre
City
Hamilton
State/Province
Ontario
ZIP/Postal Code
L8N 3Z5
Country
Canada
Facility Name
Diex Recherche - Québec
City
Québec
State/Province
Quebec
ZIP/Postal Code
G1N 4V3
Country
Canada
Facility Name
Clinique Spécialisée en Allergie de la Capitale
City
Québec
State/Province
Quebec
ZIP/Postal Code
G1V 4W2
Country
Canada
Facility Name
Inspiration Research Limited
City
Toronto
State/Province
Quebec
ZIP/Postal Code
M5T 3A9
Country
Canada
Facility Name
C I C Maurice Inc
City
Trois-Rivières
State/Province
Quebec
ZIP/Postal Code
G8T 7A1
Country
Canada
Facility Name
Diex Recherche - Victoriaville
City
Victoriaville
State/Province
Quebec
ZIP/Postal Code
G6P 6P6
Country
Canada
Facility Name
MUDr. I. Cierná Peterová s.r.o.
City
Brandýs Nad Labem-Stará Boleslav
State/Province
Central Bohemia
ZIP/Postal Code
250 01
Country
Czechia
Facility Name
Pneumologie Varnsdorf S.r.o.
City
Nový Bor
State/Province
Liberec
ZIP/Postal Code
473 01
Country
Czechia
Facility Name
Plicní ambulance Rokycany s.r.o.
City
Rokycany
State/Province
Plzeň
ZIP/Postal Code
33701
Country
Czechia
Facility Name
Synexus Czech s.r.o.
City
Praha
State/Province
Prague
ZIP/Postal Code
120 00
Country
Czechia
Facility Name
MediTrial s.r.o.
City
Jindřichův Hradec
State/Province
South Bohemia
ZIP/Postal Code
377 01
Country
Czechia
Facility Name
MUDr. Jaroslav Mares - odborny lekar pro obor tuberkulosa a respiracni nemoci
City
Strakonice
State/Province
South Bohemia
ZIP/Postal Code
386 01
Country
Czechia
Facility Name
Plicni stredisko Teplice s.r.o.
City
Teplice
State/Province
Ústí Nad Labem
ZIP/Postal Code
415 01
Country
Czechia
Facility Name
Thoraxklinik-Heidelberg gGmbH
City
Heidelberg
State/Province
Baden-Württemberg
ZIP/Postal Code
69126
Country
Germany
Facility Name
Synexus Frankfurt Research Centre
City
Frankfurt am main
State/Province
Hessen
ZIP/Postal Code
60313
Country
Germany
Facility Name
IKF Pneumologie
City
Frankfurt
State/Province
Hessen
ZIP/Postal Code
60596
Country
Germany
Facility Name
Zentrum für ambulante pneumologische Forschung Marburg GbR
City
Marburg
State/Province
Hessen
ZIP/Postal Code
35037
Country
Germany
Facility Name
Ballenberger. Freytag. Wenisch - Institut fuer klinische Forschung GmbH
City
Neu Isenburg
State/Province
Hessen
ZIP/Postal Code
63263
Country
Germany
Facility Name
Kfns Klinische Forschung Schwerin
City
Schwerin
State/Province
Mecklenburg-Vorpommern
ZIP/Postal Code
19055
Country
Germany
Facility Name
Universitätsklinikum Bonn
City
Bonn
State/Province
Nordrhein-Westfalen
ZIP/Postal Code
53127
Country
Germany
Facility Name
Klinische Forschung Dresden GmbH (KFGN)
City
Dresden
State/Province
Sachsen
ZIP/Postal Code
01069
Country
Germany
Facility Name
Synexus Leipzig Research Centre
City
Leipzig
State/Province
Sachsen
ZIP/Postal Code
04103
Country
Germany
Facility Name
Ärztezentrum Axel Springer Passage
City
Berlin
ZIP/Postal Code
10969
Country
Germany
Facility Name
Da Vinci Maganklinika
City
Pécs
State/Province
Baranya
ZIP/Postal Code
7635
Country
Hungary
Facility Name
Synexus Gyula - Magyarország Egészségügyi Szolgáltató Kft
City
Gyula
State/Province
Békés
ZIP/Postal Code
5700
Country
Hungary
Facility Name
Szent Borbála Kórház
City
Tatabánya
State/Province
Nograd
ZIP/Postal Code
2800
Country
Hungary
Facility Name
Dr. Kenessey Albert Korhaz-Rendelointezet
City
Balassagyarmat
State/Province
Nógrád
ZIP/Postal Code
2660
Country
Hungary
Facility Name
Synexus Zalaegerszeg Magyarország Egészségügyi Kft
City
Zalaegerszeg
State/Province
Zala
ZIP/Postal Code
8900
Country
Hungary
Facility Name
Synexus Budapest - Magyarország Egészségügyi Szolgáltató Kft
City
Budapest
ZIP/Postal Code
1036
Country
Hungary
Facility Name
Osrodek Badan Klinicznych CLINSANTE S.C. Ewa Galczak-Nowak Malgorzata Trzaska
City
Bydgoszcz
State/Province
Kujawsko-pomorskie
ZIP/Postal Code
31-826
Country
Poland
Facility Name
Medical Center Kermed
City
Bydgoszcz
State/Province
Kujawsko-pomorskie
ZIP/Postal Code
85-231
Country
Poland
Facility Name
Centrum Medyczne Bydgoszcz - PRATIA
City
Bydgoszcz
State/Province
Kujawsko-pomorskie
ZIP/Postal Code
85-796
Country
Poland
Facility Name
Synexus Polska Sp. Z o.o Oddzial w Lodzi
City
Łódź
State/Province
Lodzkie
ZIP/Postal Code
90-127
Country
Poland
Facility Name
KLIMED
City
Bychawa
State/Province
Lubelskie
ZIP/Postal Code
23-100
Country
Poland
Facility Name
Clinical Best Solutions -Lublin
City
Lublin
State/Province
Lubelskie
ZIP/Postal Code
20-078
Country
Poland
Facility Name
Centrum Alergologii Specjalistyczna Przychodnia Alergologiczna
City
Lublin
State/Province
Lubelskie
ZIP/Postal Code
20-552
Country
Poland
Facility Name
Centrum Medyczne Warszawa - PRATIA
City
Warszawa
State/Province
Mazowieckie
ZIP/Postal Code
01-869
Country
Poland
Facility Name
Alergo-Med Specjalistyczna Przychodnia Lekarska Sp. z.o.o
City
Tarnów
State/Province
Małopolskie
ZIP/Postal Code
33-100
Country
Poland
Facility Name
Prywatny Gabinet Internistyczno-Alergologiczny
City
Białystok
State/Province
Podlaskie
ZIP/Postal Code
15-010
Country
Poland
Facility Name
Synexus Polska Sp. z o.o. Oddzial w Gdansku
City
Gdansk
State/Province
Pomorskie
ZIP/Postal Code
80-382
Country
Poland
Facility Name
Centrum Medyczne Wos i Piwowarczyk
City
Kraków
State/Province
Łódzkie
ZIP/Postal Code
31-572
Country
Poland
Facility Name
Synexus Polska Sp. z o.o. Oddzial w Czestochowie
City
Częstochowa
State/Province
Śląskie
ZIP/Postal Code
42-202
Country
Poland
Facility Name
Ostrowieckie Centrum Medyczne Spólka Cywilna Anna Olech-Cudzik, Krzysztof Cudzik
City
Ostrowiec Świętokrzyski
State/Province
Świętokrzyskie
ZIP/Postal Code
27-400
Country
Poland
Facility Name
Synexus Midlands Clinical Research Centre
City
Birmingham
State/Province
England
ZIP/Postal Code
B15 2SQ
Country
United Kingdom
Facility Name
West Walk Surgery
City
Bristol
State/Province
England
ZIP/Postal Code
BS37 4AX
Country
United Kingdom
Facility Name
MeDiNova Northamptonshire Quality Research Site
City
Corby
State/Province
England
ZIP/Postal Code
NN18 9EZ
Country
United Kingdom
Facility Name
Castle Hill Hospital
City
Cottingham
State/Province
England
ZIP/Postal Code
HU16 5JQ
Country
United Kingdom
Facility Name
MeDiNova Warwickshire Quality Research Site
City
Kenilworth
State/Province
England
ZIP/Postal Code
CV8 1JD
Country
United Kingdom
Facility Name
Kings College Hospital
City
London
State/Province
England
ZIP/Postal Code
SE5 9RS
Country
United Kingdom
Facility Name
Royal Brompton Hospital
City
London
State/Province
England
ZIP/Postal Code
SW3 6NP
Country
United Kingdom
Facility Name
NW Consortium Manchester
City
Manchester
State/Province
England
ZIP/Postal Code
M15 6SX
Country
United Kingdom
Facility Name
Wythenshawe Hospital - PPDS
City
Manchester
State/Province
England
ZIP/Postal Code
M23 9LT
Country
United Kingdom
Facility Name
MeDiNova North London Quality Research Site
City
Middlesex
State/Province
England
ZIP/Postal Code
HA6 2RN
Country
United Kingdom
Facility Name
North Tyneside General Hospital
City
North Shields
State/Province
England
ZIP/Postal Code
NE29 8NH
Country
United Kingdom
Facility Name
MeDiNova East London Quality Research Site
City
Romford
State/Province
England
ZIP/Postal Code
RM1 3PJ
Country
United Kingdom
Facility Name
MeDiNova Yorkshire Quality Research Site
City
Shipley
State/Province
England
ZIP/Postal Code
BD18 3SA
Country
United Kingdom
Facility Name
MeDiNova South London Quality Research Site
City
Sidcup
State/Province
England
ZIP/Postal Code
DA14 6LT
Country
United Kingdom
Facility Name
MeDiNova West London Quality Research Site
City
Wokingham
State/Province
England
ZIP/Postal Code
RG40 1XS
Country
United Kingdom
Facility Name
Ormeau Clinical Trials Limited
City
Belfast
State/Province
Northern Ireland
ZIP/Postal Code
BT7 2EB
Country
United Kingdom
Facility Name
Belfast City Hospital
City
Belfast
State/Province
Northern Ireland
ZIP/Postal Code
BT9 7AB
Country
United Kingdom
Facility Name
AES - Synexus Scotland Clinical Research Centre
City
Glasgow
State/Province
Scotland
ZIP/Postal Code
G20 0SP
Country
United Kingdom

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Evaluation of the Efficacy and Safety of BLU-5937 in Adults With Refractory Chronic Cough

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