Active — Not RecruitingPhase 3

A 52-Week Study of the Efficacy and Safety of BLU-5937 in Adults With Refractory Chronic Cough

United States825 participantsStarted 2022-10-25

Plain-language summary

This is a randomized, double-blind, placebo-controlled, parallel-arm, Phase 3 study of BLU-5937 in participants with Refractory Chronic Cough (RCC).

Who can participate

Age range18 Years – 80 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Capable of giving signed informed consent * Refractory chronic cough (including unexplained chronic cough) for at least one year * Women of child-bearing potential must use a highly effective contraception method during the study and for at least 14 days after the last dose Exclusion Criteria: * Current smoker/vaper (all forms of smoking and inhaled substances, including, cannabis/tobacco smoke and nicotine vapors) or individuals who have given up smoking within the past 6 months, or those with \>20 pack-year smoking history * Diagnosis of chronic obstructive pulmonary disease, bronchiectasis, chronic bronchitis, cystic fibrosis, pulmonary sarcoidosis, idiopathic pulmonary fibrosis, uncontrolled asthma, or other significant or progressive airway/respiratory disorder that might affect cough based on clinician assessment * Respiratory tract infection within 4 weeks before screening * Laboratory confirmed Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) infection at screening * History of malignancy in the last 5 years * History of alcohol or drug abuse within the last 3 years * Has a positive serologic test for human immunodeficiency virus (HIV), hepatitis B virus surface antigen, or hepatitis C virus. * Previous participation in a BLU-5937 trial

What they're measuring

24-Hour Cough Frequency

Timeframe: Week 12

Number of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs) up to Week 52

Timeframe: Up to Week 52

Number of Participants with Adverse Events of Medical Interest (AEMIs) up to Week 52

Timeframe: Up to Week 52

Number of Participants with Study Treatment Discontinuation due to AEs and SAEs up to Week 52

Timeframe: Up to Week 52

Number of Participants with AEs and SAEs Leading to Study Withdrawal up to Week 52

Timeframe: Up to Week 52

Change from Baseline in Vital Signs: Systolic and Diastolic Blood Pressure (millimeters of mercury [mm Hg]) at Week 52

Timeframe: Baseline, Week 52

Change from Baseline in Vital Sign: Pulse (beats per minute) at Week 52

Timeframe: Baseline, Week 52

Change from Baseline in Vital Sign: Respiratory Rate (breaths per minute) at Week 52

Trial details

NCT IDNCT05599191

SponsorBellus Health Inc. - a GSK company

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2025-12-18

View on ClinicalTrials.gov More Cough trials

Who can participate

Age range18 Years – 80 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

24-Hour Cough Frequency

Timeframe: Week 12

Number of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs) up to Week 52

Timeframe: Up to Week 52

Number of Participants with Adverse Events of Medical Interest (AEMIs) up to Week 52

Timeframe: Up to Week 52

Number of Participants with Study Treatment Discontinuation due to AEs and SAEs up to Week 52

Timeframe: Up to Week 52

Number of Participants with AEs and SAEs Leading to Study Withdrawal up to Week 52

Timeframe: Up to Week 52

Change from Baseline in Vital Signs: Systolic and Diastolic Blood Pressure (millimeters of mercury [mm Hg]) at Week 52

Timeframe: Baseline, Week 52

Change from Baseline in Vital Sign: Pulse (beats per minute) at Week 52

Timeframe: Baseline, Week 52

Change from Baseline in Vital Sign: Respiratory Rate (breaths per minute) at Week 52