Evaluating BLU-5937 for treating persistent cough in adults
A Phase 3, 52-Week, Randomized, Double-Blind, Placebo-Controlled, Parallel-Arm Efficacy and Safety Study With Open-Label Extension of BLU-5937 in Adult Participants With Refractory Chronic Cough, Including Unexplained Chronic Cough
This study is testing a new medication called BLU-5937 to see if it can help adults with a long-lasting cough feel better over 12 weeks.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 825 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | Bellus Health Inc. - a GSK company Industry-sponsored |
| Locations | 183 sites (Jasper, Alabama and 182 other locations) |
| Trial ID | NCT05599191 on ClinicalTrials.gov |
What this trial studies
This Phase 3 clinical trial is a randomized, double-blind, placebo-controlled study aimed at assessing the efficacy and safety of BLU-5937 in adults suffering from refractory chronic cough (RCC). Participants will be monitored for changes in their 24-hour cough frequency over a 12-week period. The study includes a parallel-arm design, where one group receives the active treatment and another receives a placebo. The trial seeks to provide insights into the potential benefits of BLU-5937 for individuals with this challenging condition.
Who should consider this trial
Good fit: Ideal candidates are adults with refractory chronic cough lasting at least one year who can provide informed consent.
Not a fit: Patients with chronic obstructive pulmonary disease (COPD), bronchiectasis, or other significant respiratory conditions will not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly reduce cough frequency and improve the quality of life for patients with refractory chronic cough.
How similar studies have performed: Previous studies have shown promise in treating chronic cough with similar approaches, but this specific treatment is being evaluated for the first time in this context.
Eligibility criteria
Show full inclusion / exclusion criteria
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 (COPD), bronchiectasis, idiopathic pulmonary fibrosis or uncontrolled asthma * 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
Where this trial is running
Jasper, Alabama and 182 other locations
- Jasper Summit Research, LLC — Jasper, Alabama, United States (Withdrawn)
- Research Solutions of Arizona, PC — Litchfield Park, Arizona, United States (Recruiting)
- Medical Research of Arizona — Scottsdale, Arizona, United States (Recruiting)
- Little Rock Allergy & Asthma, P.A. Clinical Research Center — Little Rock, Arkansas, United States (Recruiting)
- Warren W. Pleskow, MD, 1071572 — Encinitas, California, United States (Recruiting)
- Allergy & Asthma Research of Southern California — Mission Viejo, California, United States (Recruiting)
- Center for Clinical Trials, LLC — Paramount, California, United States (Recruiting)
- Allergy Associates Medical Group, Inc. — San Diego, California, United States (Recruiting)
- Care Access Research — Aurora, Colorado, United States (Recruiting)
- Innovative Research of West Florida, Inc. — Clearwater, Florida, United States (Recruiting)
- Omega Research Consultants — DeBary, Florida, United States (Recruiting)
- North Florida Foundation for Research and Education, Inc. — Gainesville, Florida, United States (Not_yet_recruiting)
- The Community Research of South Florida — Hialeah, Florida, United States (Recruiting)
- Sher Allergy — Largo, Florida, United States (Withdrawn)
- Cordova Research Institute, LLC — Miami, Florida, United States (Recruiting)
- Life Spring Research Foundation — Miami, Florida, United States (Recruiting)
- Well Pharma Medical Research Corporation — Miami, Florida, United States (Recruiting)
- Coral Research Clinic corp — Miami, Florida, United States (Recruiting)
- Gwinnett Pulmonary Group P.C. — Lawrenceville, Georgia, United States (Recruiting)
- PMG Research of DuPage Medical Group — Downers Grove, Illinois, United States (Recruiting)
- Sneeze, Wheeze and Itch Associates, LLC — Normal, Illinois, United States (Recruiting)
- McFarland Clinic P.C. — Ames, Iowa, United States (Recruiting)
- University of Iowa Hospitals & Clinics — Iowa City, Iowa, United States (Recruiting)
- University of Kansas Medical Center Research Institute, Inc. — Kansas City, Kansas, United States (Recruiting)
- Cotton O'Neil Clinical Research Center — Topeka, Kansas, United States (Recruiting)
- University of Kansas Medical Center Research Institute, Inc. — Wichita, Kansas, United States (Recruiting)
- Avant Research Associates, LLC — Crowley, Louisiana, United States (Recruiting)
- Infinity Medical Research Inc — North Dartmouth, Massachusetts, United States (Recruiting)
- Michigan Medicine Investigational Drug Services — Ann Arbor, Michigan, United States (Recruiting)
- The Curators of the University of Missouri on behalf of University of Missouri Health Care — Columbia, Missouri, United States (Recruiting)
- Montana Medical Research, Inc. — Missoula, Montana, United States (Recruiting)
- The Asthma and Allergy Center — Bellevue, Nebraska, United States (Recruiting)
- Montefiore Medical Center (MMC) — Bronx, New York, United States (Recruiting)
- American Health Research, Inc. — Charlotte, North Carolina, United States (Recruiting)
- PMG Research of Raleigh — Raleigh, North Carolina, United States (Recruiting)
- PMG Research of Rocky Mount, LLC — Rocky Mount, North Carolina, United States (Recruiting)
- PMG Research of Salisbury, LLC — Salisbury, North Carolina, United States (Recruiting)
- Southeastern Research Center LLC — Winston-Salem, North Carolina, United States (Recruiting)
- Remington-Davis, Inc. — Columbus, Ohio, United States (Recruiting)
- University of Oklahoma Health Sciences Center — Oklahoma City, Oklahoma, United States (Recruiting)
- Vital Prospects Clinical Research Institute, P.C. — Tulsa, Oklahoma, United States (Recruiting)
- Velocity Clinical Research — Medford, Oregon, United States (Recruiting)
- Allergy Associates Research Center — Portland, Oregon, United States (Recruiting)
- Clinical Research Associates of Central PA, LLC — DuBois, Pennsylvania, United States (Recruiting)
- Temple Lung Center — Philadelphia, Pennsylvania, United States (Recruiting)
- AAPRI Clinical Research Institute — Warwick, Rhode Island, United States (Recruiting)
- Lowcountry Lung and Critical Care, P.A. — Charleston, South Carolina, United States (Recruiting)
- Main Street Physician's Care - Waterway — Little River, South Carolina, United States (Recruiting)
- PMG Research of Charleston, LLC — Mount Pleasant, South Carolina, United States (Recruiting)
- Clinical Research of Rock Hill — Rock Hill, South Carolina, United States (Recruiting)
+133 more sites — see ClinicalTrials.gov for the full list.
Study contacts
- Study coordinator: US GSK Clinical Trials call Center
- Email: GSKClinicalSupportHD@gsk.com
- Phone: 877-379-3718
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.