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

Phase 2

Terminated

• Conditions: Chronic Refractory Cough
• Interventions: Drug: Placebo; Drug: BLU-5937

• Registration Number: NCT03979638
• Lead Sponsor: Bellus Health Inc. - a GSK company

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

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.

Study Timeline

• Study First Submitted: 2019-06-06
• Study First Submitted QC: 2019-06-06
• Study First Posted: 2019-06-07
• Study Start: 2019-07-10
• Status Verified: 2020-04
• Primary Completion: 2020-04-23
• Study Completion: 2020-04-23
• Results First Submitted: 2021-07-05
• Results First Submitted QC: 2021-07-31
• Last Update Submitted: 2021-07-31
• Results First Posted: 2021-08-03
• Last Update Posted: 2021-08-03

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 68

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Placebo oral tablet BID	Placebo	Randomized crossover design of matching placebo tablets to be administered orally BID
BLU-5937 oral tablet BID	BLU-5937	Randomized crossover design of 4 different doses (25, 50, 100, 200 mg BID) of BLU-5937 tablets to be administered orally BID

Primary Outcome Measures

Name	Time	Method
Change in Awake Objective Cough Frequency on Log-transformed Scale	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	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

Trial Locations

Locations (16)

Allergy Asthma & Sinus Center; 🇺🇸 Greenfield, Wisconsin, United States

Clinical Research of Gastonia; 🇺🇸 Gastonia, North Carolina, United States

Prince Phillip Hospital; 🇬🇧 Llanelli, United Kingdom

Diagnostics Research Group; 🇺🇸 San Antonio, Texas, United States

North Tyneside General Hospital; 🇬🇧 North Shields, United Kingdom

Clinical Research Institute; 🇺🇸 Minneapolis, Minnesota, United States

National Allergy & Asthma Research; 🇺🇸 Charleston, South Carolina, United States

Centre for Cough; 🇺🇸 Largo, Florida, United States

Allergy Associates Medical Group Inc.; 🇺🇸 San Diego, California, United States

University Hospitals of Leicester; 🇬🇧 Leicester, United Kingdom

King's College Hospital; 🇬🇧 London, United Kingdom

Allergy & Asthma Associates of Santa Clara Valley; 🇺🇸 San Jose, California, United States

Manchester Clinical Research Facility; 🇬🇧 Manchester, United Kingdom

Belfast City Hospital; 🇬🇧 Belfast, United Kingdom

Royal Brompton Hospital; 🇬🇧 London, United Kingdom

Castle Hill Hospital; 🇬🇧 Cottingham, United Kingdom