A Dose Escalation Study of BLU-5937 in Unexplained or Refractory Chronic Cough
NCT ID: NCT03979638
Last Updated: 2021-08-03
Study Results
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View full resultsBasic Information
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TERMINATED
PHASE2
68 participants
INTERVENTIONAL
2019-07-10
2020-04-23
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
QUADRUPLE
Study Groups
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BLU-5937 oral tablet BID
Randomized crossover design of 4 different doses (25, 50, 100, 200 mg BID) of BLU-5937 tablets to be administered orally BID
BLU-5937
Four escalating doses of BLU-5937 administered BID over the course of the study
Placebo oral tablet BID
Randomized crossover design of matching placebo tablets to be administered orally BID
Placebo
Matching placebo for BLU-5937
Interventions
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BLU-5937
Four escalating doses of BLU-5937 administered BID over the course of the study
Placebo
Matching placebo for BLU-5937
Eligibility Criteria
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Inclusion Criteria
* Chest radiograph or CT thorax within the last 60 months not demonstrating any abnormality considered to be significantly contributing to the chronic cough
* Cough count of ≥ 10 per hour (Awake Cough Count) at Screening
* Score of ≥ 40mm on the Cough Severity VAS at Screening
* Women of child-bearing potential must have a negative serum pregnancy test at Screening
* Women of child-bearing potential must use a highly effective contraception method from Screening through the Follow-Up Visit
* Male subjects and their partners of child-bearing potential must use 2 methods of acceptable birth control
Exclusion Criteria
* Diagnosis of COPD, bronchiectasis, idiopathic pulmonary fibrosis
* Treatment with an ACE-inhibitor as the potential cause of a subject's cough, or requiring treatment with an ACE-inhibitor during the study, or within 12 weeks prior to the Screening Visit
* FEV1/FVC \< 60%
* History of upper respiratory tract infection or recent significant change in pulmonary status within 4 weeks of the Baseline Visit
* History of concurrent malignancy or recurrence of malignancy within 2 years prior to Screening
* History of a diagnosis of drug or alcohol dependency or abuse within the last 3 years
* Clinically significant abnormal electrocardiogram (ECG) or laboratory tests at Screening
* Other severe, acute, or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with trial participation or investigational product administration or may interfere with the interpretation of trial results
18 Years
80 Years
ALL
No
Sponsors
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Bellus Health Inc. - a GSK company
INDUSTRY
Responsible Party
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Principal Investigators
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Jacky Smith, MD, Ph.D.
Role: PRINCIPAL_INVESTIGATOR
University of Manchester
Locations
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Allergy Associates Medical Group Inc.
San Diego, California, United States
Allergy & Asthma Associates of Santa Clara Valley
San Jose, California, United States
Centre for Cough
Largo, Florida, United States
Clinical Research Institute
Minneapolis, Minnesota, United States
Clinical Research of Gastonia
Gastonia, North Carolina, United States
National Allergy & Asthma Research
Charleston, South Carolina, United States
Diagnostics Research Group
San Antonio, Texas, United States
Allergy Asthma & Sinus Center
Greenfield, Wisconsin, United States
Belfast City Hospital
Belfast, , United Kingdom
Castle Hill Hospital
Cottingham, , United Kingdom
University Hospitals of Leicester
Leicester, , United Kingdom
Prince Phillip Hospital
Llanelli, , United Kingdom
King's College Hospital
London, , United Kingdom
Royal Brompton Hospital
London, , United Kingdom
Manchester Clinical Research Facility
Manchester, , United Kingdom
North Tyneside General Hospital
North Shields, , United Kingdom
Countries
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Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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2019-000375-16
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
BUS-P2-01
Identifier Type: -
Identifier Source: org_study_id
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