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

Chronic Refractory Cough Clinical Trial

— RELIEF  

Official title:

A Randomized, Double-Blind, Placebo-Controlled, Crossover, Dose Escalation Study of BLU-5937 in Subjects With Unexplained or Refractory Chronic Cough (RELIEF)

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03979638
• Other study ID #: BUS-P2-01
• Secondary ID: 2019-000375-16
• Status: Terminated
• Phase: Phase 2
• Start date: July 10, 2019
• Est. completion date: April 23, 2020

Study information

• Verified date: April 2020
• Source: Bellus Health Inc
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 68
• Est. completion date: April 23, 2020
• Est. primary completion date: April 23, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Chronic Refractory Cough
• Cough

Intervention

Drug:
• BLU-5937
Four escalating doses of BLU-5937 administered BID over the course of the study
• Placebo
Matching placebo for BLU-5937

Locations

Country	Name	City	State
United Kingdom	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 States	National Allergy & Asthma Research	Charleston	South Carolina
United States	Clinical Research of Gastonia	Gastonia	North Carolina
United States	Allergy Asthma & Sinus Center	Greenfield	Wisconsin
United States	Centre for Cough	Largo	Florida
United States	Clinical Research Institute	Minneapolis	Minnesota
United States	Diagnostics Research Group	San Antonio	Texas
United States	Allergy Associates Medical Group Inc.	San Diego	California
United States	Allergy & Asthma Associates of Santa Clara Valley	San Jose	California

Sponsors (1)

Lead Sponsor	Collaborator
Bellus Health Inc

Countries where clinical trial is conducted

United States,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Change in Awake Cough Frequency on Log-transformed Scale in the Subgroup of Participants With Awake Cough Frequency > or = 20 Coughs/Hour at Baseline	Change in awake cough frequency (average hourly cough frequency while the subject is awake) in the a pre-specified subgroup of participants with awake cough frequency > or = 20 coughs/hour at baseline evaluated using the VitaloJAK cough monitor with 24-hour sound recordings collected	Period 1: baseline (Day 0) and 24 hours after Day 4, 8, 12, 16 doses ; Period 2: baseline (Day 30) and 24 hours after Day 34, 38, 42, 46 doses
Other	Change in Awake Cough Frequency on Log-transformed Scale in the Subgroup of Participants With Awake Cough Frequency > or = Median (32.4 Coughs/Hour) at Baseline	Change in awake cough frequency (average hourly cough frequency while the subject is awake) in the a pre-specified subgroup of participants with awake cough frequency > or = median (32.4 coughs/hour) at baseline evaluated using the VitaloJAK cough monitor with 24-hour sound recordings collected	Period 1: baseline (Day 0) and 24 hours after Day 4, 8, 12,16 doses ; Period 2: baseline (Day 30) and 24 hours after Day 34, 38, 42, 46 doses
Primary	Change in Awake Objective Cough Frequency on Log-transformed Scale	Change in awake cough frequency (average hourly cough frequency while the subject is awake ) evaluated using the VitaloJAK cough monitor with 24-hour sound recordings collected	Period 1: baseline (Day 0) and 24 hours after Day 4, 8, 12, 16 doses ; Period 2: baseline (Day 30) and 24 hours after Day 34, 38, 42, 46 doses