RECRUITING

A 24-Week Study of the Efficacy and Safety of BLU-5937 in Adults With Refractory Chronic Cough (CALM-2)

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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

Official Title

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

Quick Facts

Study Start:2023-01-13
Study Completion:2026-06
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05600777

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 80 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Capable of giving signed informed consent
  2. * Refractory chronic cough (including unexplained chronic cough) for at least one year
  3. * 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
  1. * 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
  2. * Diagnosis of Chronic Obstructive Pulmonary Disease (COPD), bronchiectasis, idiopathic pulmonary fibrosis or uncontrolled asthma
  3. * Respiratory tract infection within 4 weeks before screening
  4. * Laboratory confirmed Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) infection at screening
  5. * History of malignancy in the last 5 years
  6. * History of alcohol or drug abuse within the last 3 years
  7. * Has a positive serologic test for human immunodeficiency virus (HIV), hepatitis B virus surface antigen, or hepatitis C virus.
  8. * Previous participation in a BLU-5937 trial

Contacts and Locations

Study Contact

US GSK Clinical Trials call Center
CONTACT
877-379-3718
GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Center
CONTACT
+44 (0) 20 89904466
GSKClinicalSupportHD@gsk.com

Study Locations (Sites)

G & L Research, LLC
Gulf Shores, Alabama, 36547
United States
Phoenix Medical Research Institute, LLC
Peoria, Arizona, 85381
United States
California Allergy & Asthma Medical Group Inc.
Los Angeles, California, 90025
United States
Southern California Institute For Respiratory Diseases, Inc.
Los Angeles, California, 90048
United States
Paradigm Clinical Research Centers, Inc.
Redding, California, 96001
United States
Precision Research Institute, LLC
San Diego, California, 92114
United States
Allergy & Asthma Associates of Santa Clara Valley
San Jose, California, 95117
United States
Colorado Allergy and Asthma Centers, PC
Denver, Colorado, 80230
United States
Clinical Site Partners, LLC d/b/a CSP Leesburg
Leesburg, Florida, 34748
United States
Savin Medical Group LLC
Miami Lakes, Florida, 33014
United States
Destin Pulmonary Critical Care, PLLS.
Santa Rosa Beach, Florida, 32459
United States
Lenus Research & Medical Group
Sweetwater, Florida, 33172
United States
In-Quest Medical Research, LLC
Norcross, Georgia, 30071
United States
The Iowa Clinic, PC
Ankeny, Iowa, 50023
United States
Minnesota Lung Center
Edina, Minnesota, 55435
United States
Mayo Clinic - Rochester
Rochester, Minnesota, 55905
United States
Minnesota Lung Center
Woodbury, Minnesota, 55125
United States
The Clinical Research Center, LLC
Saint Louis, Missouri, 63141
United States
Creighton University
Omaha, Nebraska, 68124
United States
ActivMed Practices & Research, LLC
Portsmouth, New Hampshire, 03801
United States
PMG Research of Charlotte, LLC
Charlotte, North Carolina, 28209
United States
Clinical Research of Gastonia
Gastonia, North Carolina, 28054
United States
Accellacare
Winston-Salem, North Carolina, 27103
United States
Bernstein Clinical Research Center, LLC
Cincinnati, Ohio, 45236
United States
Cleveland Clinic
Cleveland, Ohio, 44195
United States
Optimed Research, LTD
Columbus, Ohio, 43235
United States
Geisinger Medical Center
Danville, Pennsylvania, 17822
United States
Pharmacorp Clinical Trials, Inc.
Charleston, South Carolina, 29412
United States
Clinical Trials Center of Middle Tennessee
Franklin, Tennessee, 37067
United States
Houston Pulmonary, Sleep, Allergy and Asthma Associates
Cypress, Texas, 77429
United States
Quality Assurance Research Center
San Antonio, Texas, 78207
United States
AMR Norfolk, Formerly Tidewater Associates, an AMR Company
Norfolk, Virginia, 23507
United States

Collaborators and Investigators

Sponsor: Bellus Health Inc. - a GSK company

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-01-13
Study Completion Date2026-06

Study Record Updates

Study Start Date2023-01-13
Study Completion Date2026-06

Terms related to this study

Additional Relevant MeSH Terms

  • Refractory Chronic Cough