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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT05600777




Registration number
NCT05600777
Ethics application status
Date submitted
18/10/2022
Date registered
31/10/2022

Titles & IDs
Public title
A 24-Week Study of the Efficacy and Safety of BLU-5937 in Adults With Refractory Chronic Cough (CALM-2)
Scientific 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
Secondary ID [1] 0 0
BUS-P3-02
Secondary ID [2] 0 0
221851
Universal Trial Number (UTN)
Trial acronym
Linked study record

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

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - BLU-5937
Treatment: Drugs - Placebo

Experimental: BLU-5937 25 mg - BLU-5937 oral dose 25 mg twice a day.

Experimental: BLU-5937 50 mg - BLU-5937 oral dose 50 mg twice a day.

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


Treatment: Drugs: BLU-5937
Oral administration of BLU-5937 Tablets

Treatment: Drugs: Placebo
Oral administration of matching placebo for BLU-5937 Tablets
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
24-Hour Cough Frequency
Timepoint [1] 0 0
Week 24
Secondary outcome [1] 0 0
Change from Baseline in Cough Severity Visual Analogue Scale at Week 24
Timepoint [1] 0 0
Baseline, Week 24
Secondary outcome [2] 0 0
Percentage of Participants With = 30mm Reduction, = 20mm Reduction From Baseline in Cough Severity Visual Analog Scale (VAS) at Week 24
Timepoint [2] 0 0
Baseline, Week 24
Secondary outcome [3] 0 0
Percentage of Participants With =30%, =50%, and =70% Reduction From Baseline in 24-Hour Cough Frequency at Week 24
Timepoint [3] 0 0
Baseline, Week 24
Secondary outcome [4] 0 0
Change from Baseline in the Leicester Cough Questionnaire (LCQ) Total Score at Week 24
Timepoint [4] 0 0
Baseline, Week 24
Secondary outcome [5] 0 0
Percentage of Participants With a =1.3-point Increase From Baseline in Leicester Cough Questionnaire (LCQ) Total Score at Week 24
Timepoint [5] 0 0
Baseline, Week 24

Eligibility
Key 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
Minimum age
18 Years
Maximum age
80 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
13/01/2023
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/06/2026
Actual
Sample size
Target
825
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,WA
Recruitment hospital [1] 0 0
Northside Health - Coffs Harbour
Recruitment hospital [2] 0 0
John Hunter Hospital - New Lambton Heights
Recruitment hospital [3] 0 0
Lung Research QLD Pty Ltd - Chermside
Recruitment hospital [4] 0 0
The Prince Charles Hospital - Chermside
Recruitment hospital [5] 0 0
Royal Adelaide Hospital - Adelaide
Recruitment hospital [6] 0 0
Institute for Respiratory Health Inc - Nedlands
Recruitment hospital [7] 0 0
TrialsWest - Spearwood
Recruitment postcode(s) [1] 0 0
2450 - Coffs Harbour
Recruitment postcode(s) [2] 0 0
2305 - New Lambton Heights
Recruitment postcode(s) [3] 0 0
4032 - Chermside
Recruitment postcode(s) [4] 0 0
5000 - Adelaide
Recruitment postcode(s) [5] 0 0
6009 - Nedlands
Recruitment postcode(s) [6] 0 0
6163 - Spearwood
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
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United States of America
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Arizona
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United States of America
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California
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United States of America
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Colorado
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United States of America
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Florida
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United States of America
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Georgia
Country [7] 0 0
United States of America
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Iowa
Country [8] 0 0
United States of America
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Minnesota
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United States of America
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Missouri
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United States of America
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Nebraska
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United States of America
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New Hampshire
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United States of America
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North Carolina
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United States of America
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Ohio
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United States of America
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Pennsylvania
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United States of America
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South Carolina
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United States of America
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Tennessee
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United States of America
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Texas
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United States of America
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Virginia
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Czechia
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Brandýs Nad Labem
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Czechia
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Brno
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Czechia
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Kralupy Nad Vltavou
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Czechia
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Miroslav
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Czechia
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Prague
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Czechia
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Strakonice
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Germany
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Baden Wuerttemberg
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Germany
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Bayern
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Germany
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Hessen
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Germany
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Sachsen Anhalt
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Germany
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Schleswig Holstein
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Germany
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Berlin
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India
State/province [31] 0 0
Andhra Pradesh
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India
State/province [32] 0 0
Haryana
Country [33] 0 0
India
State/province [33] 0 0
Karnataka
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India
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Maharashtra
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India
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Uttar Pradesh
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Korea, Republic of
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Gangwon-do
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Korea, Republic of
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Gyeonggi-do
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Korea, Republic of
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Jeollabuk-do
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Korea, Republic of
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Busan
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Korea, Republic of
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Incheon
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Korea, Republic of
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Seoul
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New Zealand
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Auckland
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New Zealand
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Christchurch
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New Zealand
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Dunedin
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New Zealand
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Hamilton
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New Zealand
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Rotorua
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Slovakia
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Bardejov
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Slovakia
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Košice
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Slovakia
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Prievidza
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Slovakia
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Spišská Nová Ves
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Taiwan
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Chang Hua
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Taiwan
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Kaohsiung
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Taiwan
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Taoyuan
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United Kingdom
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East Riding Of Yorkshire
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United Kingdom
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Essex
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United Kingdom
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London
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United Kingdom
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Northamptonshire
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United Kingdom
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Tyne & Wear
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United Kingdom
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West Midlands
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United Kingdom
State/province [60] 0 0
Belfast

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Bellus Health Inc. - a GSK company
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
US GSK Clinical Trials call Center
Address 0 0
Country 0 0
Phone 0 0
877-379-3718
Fax 0 0
Email 0 0
GSKClinicalSupportHD@gsk.com
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT05600777