Testing BLU-5937 for treating persistent cough in adults
A Phase 3, 24-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 after 24 weeks of treatment.
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 | 100 sites (Gulf Shores, Alabama and 99 other locations) |
| Trial ID | NCT05600777 on ClinicalTrials.gov |
What this trial studies
This is a randomized, double-blind, placebo-controlled Phase 3 study evaluating the efficacy and safety of BLU-5937 in adults suffering from refractory chronic cough (RCC). The primary goal is to measure the impact of BLU-5937 on the frequency of coughing over a 24-hour period after 24 weeks of treatment. Participants will be randomly assigned to receive either the active medication or a placebo. The study aims to provide insights into a potential new treatment option 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 specified 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: Other studies have explored treatments for chronic cough, but the specific approach with BLU-5937 is novel and has not been extensively tested.
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
Gulf Shores, Alabama and 99 other locations
- G & L Research, LLC — Gulf Shores, Alabama, United States (Recruiting)
- Phoenix Medical Research Institute, LLC — Peoria, Arizona, United States (Withdrawn)
- California Allergy & Asthma Medical Group Inc. — Los Angeles, California, United States (Recruiting)
- Southern California Institute For Respiratory Diseases, Inc. — Los Angeles, California, United States (Recruiting)
- Paradigm Clinical Research Centers, Inc. — Redding, California, United States (Recruiting)
- Precision Research Institute, LLC — San Diego, California, United States (Recruiting)
- Allergy & Asthma Associates of Santa Clara Valley — San Jose, California, United States (Recruiting)
- Colorado Allergy and Asthma Centers, PC — Denver, Colorado, United States (Recruiting)
- Clinical Site Partners, LLC d/b/a CSP Leesburg — Leesburg, Florida, United States (Recruiting)
- Savin Medical Group LLC — Miami Lakes, Florida, United States (Recruiting)
- Destin Pulmonary Critical Care, PLLS. — Santa Rosa Beach, Florida, United States (Recruiting)
- Lenus Research & Medical Group — Sweetwater, Florida, United States (Recruiting)
- In-Quest Medical Research, LLC — Norcross, Georgia, United States (Recruiting)
- The Iowa Clinic, PC — Ankeny, Iowa, United States (Recruiting)
- Minnesota Lung Center — Edina, Minnesota, United States (Recruiting)
- Mayo Clinic - Rochester — Rochester, Minnesota, United States (Recruiting)
- Minnesota Lung Center — Woodbury, Minnesota, United States (Recruiting)
- The Clinical Research Center, LLC — Saint Louis, Missouri, United States (Recruiting)
- Creighton University — Omaha, Nebraska, United States (Recruiting)
- ActivMed Practices & Research, LLC — Portsmouth, New Hampshire, United States (Recruiting)
- PMG Research of Charlotte, LLC — Charlotte, North Carolina, United States (Recruiting)
- Clinical Research of Gastonia — Gastonia, North Carolina, United States (Recruiting)
- Accellacare — Winston-Salem, North Carolina, United States (Recruiting)
- Bernstein Clinical Research Center, LLC — Cincinnati, Ohio, United States (Withdrawn)
- Cleveland Clinic — Cleveland, Ohio, United States (Not_yet_recruiting)
- Optimed Research, LTD — Columbus, Ohio, United States (Recruiting)
- Geisinger Medical Center — Danville, Pennsylvania, United States (Not_yet_recruiting)
- Pharmacorp Clinical Trials, Inc. — Charleston, South Carolina, United States (Recruiting)
- Clinical Trials Center of Middle Tennessee — Franklin, Tennessee, United States (Recruiting)
- Houston Pulmonary, Sleep, Allergy and Asthma Associates — Cypress, Texas, United States (Recruiting)
- Quality Assurance Research Center — San Antonio, Texas, United States (Recruiting)
- AMR Norfolk, Formerly Tidewater Associates, an AMR Company — Norfolk, Virginia, United States (Recruiting)
- Northside Health — Coffs Harbour, New South Wales, Australia (Recruiting)
- John Hunter Hospital — New Lambton Heights, New South Wales, Australia (Not_yet_recruiting)
- Lung Research QLD Pty Ltd — Chermside, Queensland, Australia (Recruiting)
- The Prince Charles Hospital — Chermside, Queensland, Australia (Recruiting)
- Royal Adelaide Hospital — Adelaide, South Australia, Australia (Recruiting)
- Institute for Respiratory Health Inc — Nedlands, Western Australia, Australia (Recruiting)
- TrialsWest — Spearwood, Western Australia, Australia (Recruiting)
- MUDr. I. Cierna Peterova s.r.o. — Brandýs Nad Labem, Czechia (Recruiting)
- Fakultni nemocnice Brno — Brno, Czechia (Recruiting)
- MUDr. Otakar Hokynar plicni ordinace — Kralupy Nad Vltavou, Czechia (Recruiting)
- Plicni ambulance - MUDr. Ilona Pavlisova — Miroslav, Czechia (Recruiting)
- DAWON spol. s.r.o. — Prague, Czechia (Recruiting)
- MUDr. Jaroslav Mares - TBC a respir. nemoci — Strakonice, Czechia (Recruiting)
- Thoraxklinik Heidelberg gGmbH — Heidelberg, Baden Wuerttemberg, Germany (Recruiting)
- Pneumologische Praxis Pasing — Muenchen, Bayern, Germany (Recruiting)
- Lungenzentrum Darmstadt — Darmstadt, Hessen, Germany (Recruiting)
- Studienzentrum Maingau — Frankfurt am main, Hessen, Germany (Recruiting)
- Klinikum der Johann Wolfgang Goethe-Universitaet — Frankfurt, Hessen, Germany (Recruiting)
+50 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.