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A Dose Escalation Study of BLU-5937 in Unexplained or Refractory Chronic Cough (RELIEF)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03979638
Recruitment Status : Terminated (Trial was terminated due to the impact of the COVID-19 on trial activities. 68 patients with refractory chronic cough were enrolled with 52 completing treatment)
First Posted : June 7, 2019
Last Update Posted : September 2, 2020
Sponsor:
Information provided by (Responsible Party):
Bellus Health Inc

Brief Summary:
This is a multi-center, randomized, double-blind, placebo-controlled, crossover, dose escalation study of BLU-5937 in subjects with unexplained or refractory chronic cough

Condition or disease Intervention/treatment Phase
Chronic Refractory Cough Drug: BLU-5937 Drug: Placebo Phase 2

Detailed Description:
This study will have two 16-day treatment periods (four escalating doses or matching placebo at four days interval) separated by a 10 to 14-day washout period. There will be a 14-day follow-up period.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 68 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention Model Description: Two-arm, Two-Period, crossover assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized, Double-Blind, Placebo-Controlled, Crossover, Dose Escalation Study of BLU-5937 in Subjects With Unexplained or Refractory Chronic Cough (RELIEF)
Actual Study Start Date : July 10, 2019
Actual Primary Completion Date : April 23, 2020
Actual Study Completion Date : April 23, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cough

Arm Intervention/treatment
Experimental: 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
Drug: BLU-5937
Four escalating doses of BLU-5937 administered BID over the course of the study

Placebo Comparator: Placebo oral tablet BID
Randomized crossover design of matching placebo tablets to be administered orally BID
Drug: Placebo
Matching placebo for BLU-5937




Primary Outcome Measures :
  1. Awake coughs per hour at Days 4, 8, 12, 16, 34, 38, 42, 46 [ Time Frame: Change from Baseline at Days 4, 8, 12, 16, 34, 38, 42, 46 ]
    Assessment of awake coughs per hour (average hourly cough frequency while the subject is awake based on sound recordings) evaluated using the VitaloJAK cough monitor


Secondary Outcome Measures :
  1. 24-hour coughs per hour at Days 4, 8, 12, 16, 34, 38, 42, 46 [ Time Frame: Change from Baseline at Days 4, 8, 12, 16, 34, 38, 42, 46 ]
    Assessment of awake coughs per hour (average hourly cough frequency based on 24-hour sound recordings) evaluated using the VitaloJAK cough monitor

  2. Percentage of subjects who have at least one adverse event (AE) during the two treatment periods, washout, and follow-up [ Time Frame: Time Frame: up to 60 days ]
    Assessment of subjects who have at least one AE during treatment period 1 (16 days), during washout (14 days), during treatment period 2 (16 days), and follow-up (14 days)



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Unexplained or refractory chronic cough for at least one year
  • 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:

  • Current smoker or individuals who have given up smoking within the past 6 months, or those with >20 pack-year smoking history
  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03979638


Locations
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United States, California
Allergy Associates Medical Group Inc.
San Diego, California, United States, 92108
Allergy & Asthma Associates of Santa Clara Valley
San Jose, California, United States, 95117
United States, Florida
Centre for Cough
Largo, Florida, United States, 33778
United States, Minnesota
Clinical Research Institute
Minneapolis, Minnesota, United States, 55402
United States, North Carolina
Clinical Research of Gastonia
Gastonia, North Carolina, United States, 20854
United States, South Carolina
National Allergy & Asthma Research
Charleston, South Carolina, United States, 29420
United States, Texas
Diagnostics Research Group
San Antonio, Texas, United States, 78229
United States, Wisconsin
Allergy Asthma & Sinus Center
Greenfield, Wisconsin, United States, 53228
United Kingdom
Belfast City Hospital
Belfast, United Kingdom, BT9 7BL
Castle Hill Hospital
Cottingham, United Kingdom, HU16 5JQ
University Hospitals of Leicester
Leicester, United Kingdom, LE3 9QP
Prince Phillip Hospital
Llanelli, United Kingdom, SA14 8QF
King's College Hospital
London, United Kingdom, SE5 9RS
Royal Brompton Hospital
London, United Kingdom, SW3 6HP
Manchester Clinical Research Facility
Manchester, United Kingdom, M23 9LT
North Tyneside General Hospital
North Shields, United Kingdom, NE29 8NH
Sponsors and Collaborators
Bellus Health Inc
Investigators
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Principal Investigator: Jacky Smith, MD, Ph.D. University of Manchester
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Responsible Party: Bellus Health Inc
ClinicalTrials.gov Identifier: NCT03979638    
Other Study ID Numbers: BUS-P2-01
2019-000375-16 ( EudraCT Number )
First Posted: June 7, 2019    Key Record Dates
Last Update Posted: September 2, 2020
Last Verified: April 2020

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Bellus Health Inc:
Unexplained or refractory chronic cough, P2X3 antagonists
Additional relevant MeSH terms:
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Cough
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory