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A 24-Week Study of the Efficacy and Safety of BLU-5937 in Adults With Refractory Chronic Cough (CALM-2)

Primary Purpose

Refractory Chronic Cough

Status
Recruiting
Phase
Phase 3
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

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

  • G & L Research, LLCRecruiting
  • Phoenix Medical Research Institute, LLC
  • California Allergy & Asthma Medical Group Inc.Recruiting
  • Southern California Institute For Respiratory Diseases, Inc.Recruiting
  • Paradigm Clinical Research Centers, Inc.Recruiting
  • Precision Research Institute, LLCRecruiting
  • Allergy & Asthma Associates of Santa Clara ValleyRecruiting
  • Colorado Allergy and Asthma Centers, PCRecruiting
  • Clinical Site Partners, LLC d/b/a CSP LeesburgRecruiting
  • Savin Medical Group LLCRecruiting
  • Destin Pulmonary Critical Care, PLLS.Recruiting
  • Lenus Research & Medical GroupRecruiting
  • In-Quest Medical Research, LLCRecruiting
  • The Iowa Clinic, PCRecruiting
  • Minnesota Lung CenterRecruiting
  • Mayo Clinic - RochesterRecruiting
  • Minnesota Lung CenterRecruiting
  • The Clinical Research Center, LLCRecruiting
  • Creighton UniversityRecruiting
  • ActivMed Practices & Research, LLCRecruiting
  • PMG Research of Charlotte, LLCRecruiting
  • Clinical Research of GastoniaRecruiting
  • AccellacareRecruiting
  • Bernstein Clinical Research Center, LLC
  • Cleveland Clinic
  • Optimed Research, LTDRecruiting
  • Geisinger Medical Center
  • Pharmacorp Clinical Trials, Inc.Recruiting
  • Clinical Trials Center of Middle TennesseeRecruiting
  • Houston Pulmonary, Sleep, Allergy and Asthma AssociatesRecruiting
  • Quality Assurance Research CenterRecruiting
  • AMR Norfolk, Formerly Tidewater Associates, an AMR CompanyRecruiting
  • Northside HealthRecruiting
  • John Hunter Hospital
  • Lung Research QLD Pty LtdRecruiting
  • The Prince Charles HospitalRecruiting
  • Royal Adelaide Hospital
  • Institute for Respiratory Health IncRecruiting
  • TrialsWestRecruiting
  • MUDr. I. Cierna Peterova s.r.o.Recruiting
  • Fakultni nemocnice BrnoRecruiting
  • MUDr. Otakar Hokynar plicni ordinaceRecruiting
  • Plicni ambulance - MUDr. Ilona PavlisovaRecruiting
  • DAWON spol. s.r.o.Recruiting
  • MUDr. Jaroslav Mares - TBC a respir. nemociRecruiting
  • Thoraxklinik Heidelberg gGmbH
  • Pneumologische Praxis PasingRecruiting
  • Lungenzentrum DarmstadtRecruiting
  • Studienzentrum MaingauRecruiting
  • Klinikum der Johann Wolfgang Goethe-Universitaet
  • Medaimun GmbHRecruiting
  • Zentrum fuer ambulante pneumologische Forschung Marburg GbRRecruiting
  • Ballenberger Freytag Wenisch Institut für klinische Forschung
  • Pneumologicum HalleRecruiting
  • Pneumologisches Forschungsinstitut Hohegeest GbRRecruiting
  • PRI Pulmonary Research Institute
  • KLB Gesundheitsforschung Luebeck GmbHRecruiting
  • Charité Universitaetsmedizin Berlin - Campus Charité Mitte
  • Arztezentrum in der Axel-Springer-PassageRecruiting
  • Government Hospital for Chest and Communicable Diseases
  • Sarvodya Hospital
  • K.L.E. Society's Dr. Prabhakar Kore Hospital and Medical Research Centre
  • Shree Hospital and Critical Care Centre
  • Assured Care Plus Hospital
  • W. Pratiksha Hospital
  • Yonsei University Wonju Severance Christian HospitalRecruiting
  • Seoul National University Bundang HospitalRecruiting
  • Jeonbuk national university hospitalRecruiting
  • Pusan National University HospitalRecruiting
  • The Catholic University of Korea, Incheon St. Mary's HospitalRecruiting
  • Seoul National University HospitalRecruiting
  • The Catholic University of Korea, Eunpyeong St. Mary's HospitalRecruiting
  • Severance Hospital, Yonsei University Health SystemRecruiting
  • Konkuk University Medical CenterRecruiting
  • Asan Medical CenterRecruiting
  • Samsung Medical CenterRecruiting
  • The Catholic University of Korea, Seoul St. Mary's HospitalRecruiting
  • Korea University Guro HospitalRecruiting
  • Waitemata Clinical ResearchRecruiting
  • Christchurch Hospital NZRecruiting
  • Pacific Clinical Research Network - ForteRecruiting
  • Dunedin HospitalRecruiting
  • Waikato HospitalRecruiting
  • Pacific Clinical Research Network - RotoruaRecruiting
  • Alian s.r.o.Recruiting
  • Nemocnica s poliklinikou Sv. Jakuba, n.o. BardejovRecruiting
  • Zeleznicna nemocnica s poliklinikouRecruiting
  • PNEUMO-MED s.r.o.Recruiting
  • Plucna ambulancia Hrebenar, s.r.o.Recruiting
  • Changhua Christian Medical Foundation Changhua Christian HospitalRecruiting
  • Kaohsiung Medical University Chung-Ho Memorial HospitalRecruiting
  • E-DA HospitalRecruiting
  • Chang Gung Memorial Hospital,LinkouRecruiting
  • Castle Hill Hospital
  • Broomfield Hospital
  • King's College Hospital
  • Accellacare NorthamptonshireRecruiting
  • North Tyneside General Hospital
  • Accellacare WarwickshireRecruiting
  • Ormeau Clinical Trials Ltd

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Placebo Comparator

Arm Label

BLU-5937 25 mg

BLU-5937 50 mg

Placebo

Arm Description

BLU-5937 oral dose 25 mg twice a day.

BLU-5937 oral dose 50 mg twice a day.

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

Outcomes

Primary Outcome Measures

24-Hour Cough Frequency
Assessed using an ambulatory cough monitor

Secondary Outcome Measures

Change from Baseline in Cough Severity Visual Analogue Scale at Week 24
Assessed by Cough Severity Visual Analogue Scale [VAS] by the participant on a 100 mm visual analog scale where higher scores indicate greater severity.
Percentage of Participants With ≥ 30mm Reduction, ≥ 20mm Reduction From Baseline in Cough Severity Visual Analog Scale (VAS) at Week 24
Assessed by Cough Severity Visual Analogue Scale [VAS] by the participant on a 100 mm visual analog scale where higher scores indicate greater severity.
Percentage of Participants With ≥30%, ≥50%, and ≥70% Reduction From Baseline in 24-Hour Cough Frequency at Week 24
Assessed using an ambulatory cough monitor
Change from Baseline in the Leicester Cough Questionnaire (LCQ) Total Score at Week 24
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 impact of cough on 3 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.
Percentage of Participants With a ≥1.3-point Increase From Baseline in Leicester Cough Questionnaire (LCQ) Total Score at Week 24
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 impact of cough on 3 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.

Full Information

First Posted
October 18, 2022
Last Updated
September 12, 2023
Sponsor
Bellus Health Inc
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1. Study Identification

Unique Protocol Identification Number
NCT05600777
Brief Title
A 24-Week Study of the Efficacy and Safety of BLU-5937 in Adults With Refractory Chronic Cough (CALM-2)
Official Title
A Phase 3, 24-Week, Randomized, Double-Blind, Placebo-Controlled, Parallel-Arm Efficacy and Safety Study With Open-Label Extension of BLU-5937 in Adult Participants With Refractory Chronic Cough, Including Unexplained Chronic Cough
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 13, 2023 (Actual)
Primary Completion Date
July 2025 (Anticipated)
Study Completion Date
July 2025 (Anticipated)

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
Yes

5. Study Description

Brief Summary
This is a randomized, double-blind, placebo-controlled, parallel-arm, Phase 3 study of BLU-5937 in participants with Refractory Chronic Cough (RCC).
Detailed Description
The primary efficacy objective is to assess the effect of BLU-5937 on 24-hour cough frequency in adults with refractory chronic cough (including unexplained chronic cough) at 24 weeks.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Refractory Chronic Cough

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
675 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
BLU-5937 25 mg
Arm Type
Experimental
Arm Description
BLU-5937 oral dose 25 mg twice a day.
Arm Title
BLU-5937 50 mg
Arm Type
Experimental
Arm Description
BLU-5937 oral dose 50 mg twice a day.
Arm Title
Placebo
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
24-Hour Cough Frequency
Description
Assessed using an ambulatory cough monitor
Time Frame
Week 24
Secondary Outcome Measure Information:
Title
Change from Baseline in Cough Severity Visual Analogue Scale at Week 24
Description
Assessed by Cough Severity Visual Analogue Scale [VAS] by the participant on a 100 mm visual analog scale where higher scores indicate greater severity.
Time Frame
Baseline, Week 24
Title
Percentage of Participants With ≥ 30mm Reduction, ≥ 20mm Reduction From Baseline in Cough Severity Visual Analog Scale (VAS) at Week 24
Description
Assessed by Cough Severity Visual Analogue Scale [VAS] by the participant on a 100 mm visual analog scale where higher scores indicate greater severity.
Time Frame
Baseline, Week 24
Title
Percentage of Participants With ≥30%, ≥50%, and ≥70% Reduction From Baseline in 24-Hour Cough Frequency at Week 24
Description
Assessed using an ambulatory cough monitor
Time Frame
Baseline, Week 24
Title
Change from Baseline in the Leicester Cough Questionnaire (LCQ) Total Score at Week 24
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 impact of cough on 3 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
Baseline, Week 24
Title
Percentage of Participants With a ≥1.3-point Increase From Baseline in Leicester Cough Questionnaire (LCQ) Total Score at Week 24
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 impact of cough on 3 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
Baseline, Week 24

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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Robert Forrest
Phone
2673729197
Email
calm@bellushealth.com
Facility Information:
Facility Name
G & L Research, LLC
City
Gulf Shores
State/Province
Alabama
ZIP/Postal Code
36547
Country
United States
Individual Site Status
Recruiting
Facility Name
Phoenix Medical Research Institute, LLC
City
Peoria
State/Province
Arizona
ZIP/Postal Code
85381
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
California Allergy & Asthma Medical Group Inc.
City
Los Angeles
State/Province
California
ZIP/Postal Code
90025
Country
United States
Individual Site Status
Recruiting
Facility Name
Southern California Institute For Respiratory Diseases, Inc.
City
Los Angeles
State/Province
California
ZIP/Postal Code
90048
Country
United States
Individual Site Status
Recruiting
Facility Name
Paradigm Clinical Research Centers, Inc.
City
Redding
State/Province
California
ZIP/Postal Code
96001
Country
United States
Individual Site Status
Recruiting
Facility Name
Precision Research Institute, LLC
City
San Diego
State/Province
California
ZIP/Postal Code
92114
Country
United States
Individual Site Status
Recruiting
Facility Name
Allergy & Asthma Associates of Santa Clara Valley
City
San Jose
State/Province
California
ZIP/Postal Code
95117
Country
United States
Individual Site Status
Recruiting
Facility Name
Colorado Allergy and Asthma Centers, PC
City
Denver
State/Province
Colorado
ZIP/Postal Code
80230
Country
United States
Individual Site Status
Recruiting
Facility Name
Clinical Site Partners, LLC d/b/a CSP Leesburg
City
Leesburg
State/Province
Florida
ZIP/Postal Code
34748
Country
United States
Individual Site Status
Recruiting
Facility Name
Savin Medical Group LLC
City
Miami Lakes
State/Province
Florida
ZIP/Postal Code
33014
Country
United States
Individual Site Status
Recruiting
Facility Name
Destin Pulmonary Critical Care, PLLS.
City
Santa Rosa Beach
State/Province
Florida
ZIP/Postal Code
32459
Country
United States
Individual Site Status
Recruiting
Facility Name
Lenus Research & Medical Group
City
Sweetwater
State/Province
Florida
ZIP/Postal Code
33172
Country
United States
Individual Site Status
Recruiting
Facility Name
In-Quest Medical Research, LLC
City
Norcross
State/Province
Georgia
ZIP/Postal Code
30071
Country
United States
Individual Site Status
Recruiting
Facility Name
The Iowa Clinic, PC
City
Ankeny
State/Province
Iowa
ZIP/Postal Code
50023
Country
United States
Individual Site Status
Recruiting
Facility Name
Minnesota Lung Center
City
Edina
State/Province
Minnesota
ZIP/Postal Code
55435
Country
United States
Individual Site Status
Recruiting
Facility Name
Mayo Clinic - Rochester
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
Individual Site Status
Recruiting
Facility Name
Minnesota Lung Center
City
Woodbury
State/Province
Minnesota
ZIP/Postal Code
55125
Country
United States
Individual Site Status
Recruiting
Facility Name
The Clinical Research Center, LLC
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63141
Country
United States
Individual Site Status
Recruiting
Facility Name
Creighton University
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68124
Country
United States
Individual Site Status
Recruiting
Facility Name
ActivMed Practices & Research, LLC
City
Portsmouth
State/Province
New Hampshire
ZIP/Postal Code
03801
Country
United States
Individual Site Status
Recruiting
Facility Name
PMG Research of Charlotte, LLC
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28209
Country
United States
Individual Site Status
Recruiting
Facility Name
Clinical Research of Gastonia
City
Gastonia
State/Province
North Carolina
ZIP/Postal Code
28054
Country
United States
Individual Site Status
Recruiting
Facility Name
Accellacare
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27103
Country
United States
Individual Site Status
Recruiting
Facility Name
Bernstein Clinical Research Center, LLC
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45236
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
Cleveland Clinic
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
Optimed Research, LTD
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43235
Country
United States
Individual Site Status
Recruiting
Facility Name
Geisinger Medical Center
City
Danville
State/Province
Pennsylvania
ZIP/Postal Code
17822
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
Pharmacorp Clinical Trials, Inc.
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29412
Country
United States
Individual Site Status
Recruiting
Facility Name
Clinical Trials Center of Middle Tennessee
City
Franklin
State/Province
Tennessee
ZIP/Postal Code
37067
Country
United States
Individual Site Status
Recruiting
Facility Name
Houston Pulmonary, Sleep, Allergy and Asthma Associates
City
Cypress
State/Province
Texas
ZIP/Postal Code
77429
Country
United States
Individual Site Status
Recruiting
Facility Name
Quality Assurance Research Center
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78207
Country
United States
Individual Site Status
Recruiting
Facility Name
AMR Norfolk, Formerly Tidewater Associates, an AMR Company
City
Norfolk
State/Province
Virginia
ZIP/Postal Code
23507
Country
United States
Individual Site Status
Recruiting
Facility Name
Northside Health
City
Coffs Harbour
State/Province
New South Wales
ZIP/Postal Code
2450
Country
Australia
Individual Site Status
Recruiting
Facility Name
John Hunter Hospital
City
New Lambton Heights
State/Province
New South Wales
ZIP/Postal Code
2305
Country
Australia
Individual Site Status
Not yet recruiting
Facility Name
Lung Research QLD Pty Ltd
City
Chermside
State/Province
Queensland
ZIP/Postal Code
4032
Country
Australia
Individual Site Status
Recruiting
Facility Name
The Prince Charles Hospital
City
Chermside
State/Province
Queensland
ZIP/Postal Code
4032
Country
Australia
Individual Site Status
Recruiting
Facility Name
Royal Adelaide Hospital
City
Adelaide
State/Province
South Australia
ZIP/Postal Code
5000
Country
Australia
Individual Site Status
Not yet recruiting
Facility Name
Institute for Respiratory Health Inc
City
Nedlands
State/Province
Western Australia
ZIP/Postal Code
6009
Country
Australia
Individual Site Status
Recruiting
Facility Name
TrialsWest
City
Spearwood
State/Province
Western Australia
ZIP/Postal Code
6163
Country
Australia
Individual Site Status
Recruiting
Facility Name
MUDr. I. Cierna Peterova s.r.o.
City
Brandýs Nad Labem
ZIP/Postal Code
25001
Country
Czechia
Individual Site Status
Recruiting
Facility Name
Fakultni nemocnice Brno
City
Brno
ZIP/Postal Code
62500
Country
Czechia
Individual Site Status
Recruiting
Facility Name
MUDr. Otakar Hokynar plicni ordinace
City
Kralupy Nad Vltavou
ZIP/Postal Code
278 01
Country
Czechia
Individual Site Status
Recruiting
Facility Name
Plicni ambulance - MUDr. Ilona Pavlisova
City
Miroslav
ZIP/Postal Code
671 72
Country
Czechia
Individual Site Status
Recruiting
Facility Name
DAWON spol. s.r.o.
City
Prague
ZIP/Postal Code
14800
Country
Czechia
Individual Site Status
Recruiting
Facility Name
MUDr. Jaroslav Mares - TBC a respir. nemoci
City
Strakonice
ZIP/Postal Code
386 01
Country
Czechia
Individual Site Status
Recruiting
Facility Name
Thoraxklinik Heidelberg gGmbH
City
Heidelberg
State/Province
Baden Wuerttemberg
ZIP/Postal Code
69126
Country
Germany
Individual Site Status
Not yet recruiting
Facility Name
Pneumologische Praxis Pasing
City
Muenchen
State/Province
Bayern
ZIP/Postal Code
81241
Country
Germany
Individual Site Status
Recruiting
Facility Name
Lungenzentrum Darmstadt
City
Darmstadt
State/Province
Hessen
ZIP/Postal Code
64283
Country
Germany
Individual Site Status
Recruiting
Facility Name
Studienzentrum Maingau
City
Frankfurt am main
State/Province
Hessen
ZIP/Postal Code
60315
Country
Germany
Individual Site Status
Recruiting
Facility Name
Klinikum der Johann Wolfgang Goethe-Universitaet
City
Frankfurt
State/Province
Hessen
ZIP/Postal Code
60590
Country
Germany
Individual Site Status
Not yet recruiting
Facility Name
Medaimun GmbH
City
Frankfurt
State/Province
Hessen
ZIP/Postal Code
60596
Country
Germany
Individual Site Status
Recruiting
Facility Name
Zentrum fuer ambulante pneumologische Forschung Marburg GbR
City
Marburg
State/Province
Hessen
ZIP/Postal Code
35037
Country
Germany
Individual Site Status
Recruiting
Facility Name
Ballenberger Freytag Wenisch Institut für klinische Forschung
City
Neu Isenburg
State/Province
Hessen
ZIP/Postal Code
63263
Country
Germany
Individual Site Status
Not yet recruiting
Facility Name
Pneumologicum Halle
City
Halle
State/Province
Sachsen Anhalt
ZIP/Postal Code
06108
Country
Germany
Individual Site Status
Recruiting
Facility Name
Pneumologisches Forschungsinstitut Hohegeest GbR
City
Geesthacht
State/Province
Schleswig Holstein
ZIP/Postal Code
21502
Country
Germany
Individual Site Status
Recruiting
Facility Name
PRI Pulmonary Research Institute
City
Großhansdorf
State/Province
Schleswig Holstein
ZIP/Postal Code
22927
Country
Germany
Individual Site Status
Not yet recruiting
Facility Name
KLB Gesundheitsforschung Luebeck GmbH
City
Luebeck
State/Province
Schleswig Holstein
ZIP/Postal Code
23552
Country
Germany
Individual Site Status
Recruiting
Facility Name
Charité Universitaetsmedizin Berlin - Campus Charité Mitte
City
Berlin
ZIP/Postal Code
10117
Country
Germany
Individual Site Status
Not yet recruiting
Facility Name
Arztezentrum in der Axel-Springer-Passage
City
Berlin
ZIP/Postal Code
10969
Country
Germany
Individual Site Status
Recruiting
Facility Name
Government Hospital for Chest and Communicable Diseases
City
Visakhapatnam
State/Province
Andhra Pradesh
ZIP/Postal Code
530017
Country
India
Individual Site Status
Not yet recruiting
Facility Name
Sarvodya Hospital
City
Faridabad
State/Province
Haryana
ZIP/Postal Code
121006
Country
India
Individual Site Status
Not yet recruiting
Facility Name
K.L.E. Society's Dr. Prabhakar Kore Hospital and Medical Research Centre
City
Belgaum
State/Province
Karnataka
ZIP/Postal Code
590010
Country
India
Individual Site Status
Not yet recruiting
Facility Name
Shree Hospital and Critical Care Centre
City
Nagpur
State/Province
Maharashtra
ZIP/Postal Code
440009
Country
India
Individual Site Status
Not yet recruiting
Facility Name
Assured Care Plus Hospital
City
Nashik
State/Province
Maharashtra
ZIP/Postal Code
422001
Country
India
Individual Site Status
Not yet recruiting
Facility Name
W. Pratiksha Hospital
City
Varanasi
State/Province
Uttar Pradesh
ZIP/Postal Code
221005
Country
India
Individual Site Status
Not yet recruiting
Facility Name
Yonsei University Wonju Severance Christian Hospital
City
Wŏnju
State/Province
Gangwon-do
ZIP/Postal Code
26426
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Name
Seoul National University Bundang Hospital
City
Seongnam
State/Province
Gyeonggi-do
ZIP/Postal Code
13620
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Name
Jeonbuk national university hospital
City
Jeonju
State/Province
Jeollabuk-do
ZIP/Postal Code
54907
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Name
Pusan National University Hospital
City
Busan
ZIP/Postal Code
49241
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Name
The Catholic University of Korea, Incheon St. Mary's Hospital
City
Incheon
ZIP/Postal Code
21431
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Name
Seoul National University Hospital
City
Seoul
ZIP/Postal Code
03080
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Name
The Catholic University of Korea, Eunpyeong St. Mary's Hospital
City
Seoul
ZIP/Postal Code
03312
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Name
Severance Hospital, Yonsei University Health System
City
Seoul
ZIP/Postal Code
03722
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Name
Konkuk University Medical Center
City
Seoul
ZIP/Postal Code
05030
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Name
Asan Medical Center
City
Seoul
ZIP/Postal Code
05505
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Name
Samsung Medical Center
City
Seoul
ZIP/Postal Code
06351
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Name
The Catholic University of Korea, Seoul St. Mary's Hospital
City
Seoul
ZIP/Postal Code
06591
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Name
Korea University Guro Hospital
City
Seoul
ZIP/Postal Code
08308
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Name
Waitemata Clinical Research
City
Auckland
ZIP/Postal Code
0626
Country
New Zealand
Individual Site Status
Recruiting
Facility Name
Christchurch Hospital NZ
City
Christchurch
ZIP/Postal Code
8011
Country
New Zealand
Individual Site Status
Recruiting
Facility Name
Pacific Clinical Research Network - Forte
City
Christchurch
ZIP/Postal Code
8013
Country
New Zealand
Individual Site Status
Recruiting
Facility Name
Dunedin Hospital
City
Dunedin
ZIP/Postal Code
9016
Country
New Zealand
Individual Site Status
Recruiting
Facility Name
Waikato Hospital
City
Hamilton
ZIP/Postal Code
3200
Country
New Zealand
Individual Site Status
Recruiting
Facility Name
Pacific Clinical Research Network - Rotorua
City
Rotorua
ZIP/Postal Code
3010
Country
New Zealand
Individual Site Status
Recruiting
Facility Name
Alian s.r.o.
City
Bardejov
ZIP/Postal Code
08501
Country
Slovakia
Individual Site Status
Recruiting
Facility Name
Nemocnica s poliklinikou Sv. Jakuba, n.o. Bardejov
City
Bardejov
ZIP/Postal Code
08501
Country
Slovakia
Individual Site Status
Recruiting
Facility Name
Zeleznicna nemocnica s poliklinikou
City
Košice
ZIP/Postal Code
04001
Country
Slovakia
Individual Site Status
Recruiting
Facility Name
PNEUMO-MED s.r.o.
City
Prievidza
ZIP/Postal Code
97101
Country
Slovakia
Individual Site Status
Recruiting
Facility Name
Plucna ambulancia Hrebenar, s.r.o.
City
Spišská Nová Ves
ZIP/Postal Code
05201
Country
Slovakia
Individual Site Status
Recruiting
Facility Name
Changhua Christian Medical Foundation Changhua Christian Hospital
City
Chang Hua
ZIP/Postal Code
50006
Country
Taiwan
Individual Site Status
Recruiting
Facility Name
Kaohsiung Medical University Chung-Ho Memorial Hospital
City
Kaohsiung
ZIP/Postal Code
807
Country
Taiwan
Individual Site Status
Recruiting
Facility Name
E-DA Hospital
City
Kaohsiung
ZIP/Postal Code
82445
Country
Taiwan
Individual Site Status
Recruiting
Facility Name
Chang Gung Memorial Hospital,Linkou
City
Taoyuan
ZIP/Postal Code
333
Country
Taiwan
Individual Site Status
Recruiting
Facility Name
Castle Hill Hospital
City
Cottingham
State/Province
East Riding Of Yorkshire
ZIP/Postal Code
HU16 5JQ
Country
United Kingdom
Individual Site Status
Not yet recruiting
Facility Name
Broomfield Hospital
City
Chelmsford
State/Province
Essex
ZIP/Postal Code
CM1 7ET
Country
United Kingdom
Individual Site Status
Not yet recruiting
Facility Name
King's College Hospital
City
Denmark Hill
State/Province
London
ZIP/Postal Code
SE5 9R2
Country
United Kingdom
Individual Site Status
Not yet recruiting
Facility Name
Accellacare Northamptonshire
City
Corby
State/Province
Northamptonshire
ZIP/Postal Code
NN18 9EZ
Country
United Kingdom
Individual Site Status
Recruiting
Facility Name
North Tyneside General Hospital
City
North Shields
State/Province
Tyne & Wear
ZIP/Postal Code
NE29 8NH
Country
United Kingdom
Individual Site Status
Not yet recruiting
Facility Name
Accellacare Warwickshire
City
Coventry
State/Province
West Midlands
ZIP/Postal Code
CV3 4FJ
Country
United Kingdom
Individual Site Status
Recruiting
Facility Name
Ormeau Clinical Trials Ltd
City
Belfast
ZIP/Postal Code
BT7 2EB
Country
United Kingdom
Individual Site Status
Not yet recruiting

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

A 24-Week Study of the Efficacy and Safety of BLU-5937 in Adults With Refractory Chronic Cough (CALM-2)

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