Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 1 of 2 for:    BLU-5937
Previous Study | Return to List | Next Study

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03979638
Recruitment Status : Recruiting
First Posted : June 7, 2019
Last Update Posted : September 4, 2019
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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 65 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
Estimated Primary Completion Date : April 15, 2020
Estimated Study Completion Date : April 30, 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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
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 12 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 4 weeks prior to the Baseline 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


Contacts
Layout table for location contacts
Contact: Laurent Harvey, M.Sc. 450-680-4401 lharvey@bellushealth.com
Contact: Denis Garceau, Ph.D. 450-680-4400 dgarceau@bellushealth.com

Locations
Layout table for location information
United States, California
Allergy & Asthma Associates of Santa Clara Valley Recruiting
San Jose, California, United States, 95117
United States, Florida
Centre for Cough Recruiting
Largo, Florida, United States, 33778
United States, Texas
Diagnostics Research Group Recruiting
San Antonio, Texas, United States, 78229
United Kingdom
Belfast City Hospital Not yet recruiting
Belfast, United Kingdom, BT9 7BL
Castle Hill Hospital Active, not recruiting
Cottingham, United Kingdom, HU16 5JQ
University Hospitals of Leicester Not yet recruiting
Leicester, United Kingdom, LE3 9QP
King's College Hospital Recruiting
London, United Kingdom, SE5 9RS
Royal Brompton Hospital Active, not recruiting
London, United Kingdom, SW3 6HP
Manchester Clinical Research Facility Not yet recruiting
Manchester, United Kingdom, M23 9LT
North Tyneside General Hospital Not yet recruiting
North Shields, United Kingdom, NE29 8NH
Sponsors and Collaborators
Bellus Health Inc
Investigators
Layout table for investigator information
Principal Investigator: Jacky Smith, MD, Ph.D. University of Manchester

Layout table for additonal information
Responsible Party: Bellus Health Inc
ClinicalTrials.gov Identifier: NCT03979638     History of Changes
Other Study ID Numbers: BUS-P2-01
2019-000375-16 ( EudraCT Number )
First Posted: June 7, 2019    Key Record Dates
Last Update Posted: September 4, 2019
Last Verified: July 2019

Layout table for additional information
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:
Layout table for MeSH terms
Cough
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Signs and Symptoms