ACTIVE_NOT_RECRUITING

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

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Conditions

CoughRefractory Chronic CoughRespiration DisordersRespiratory Tract DiseasesSigns and Symptoms, RespiratoryChronic Cough

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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, 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 (CALM-1)

Quick Facts

Study Start:2022-10-25
Study Completion:2026-05-28
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:ACTIVE_NOT_RECRUITING

Study ID

NCT05599191

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, 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
  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

Principal Investigator

GSK Clinical Trials
STUDY_DIRECTOR
GlaxoSmithKline

Study Locations (Sites)

GSK Investigational Site
Litchfield Park, Arizona, 85340
United States
GSK Investigational Site
Scottsdale, Arizona, 85248
United States
GSK Investigational Site
Encinitas, California, 92024
United States
GSK Investigational Site
Mission Viejo, California, 92691
United States
GSK Investigational Site
Paramount, California, 90723
United States
GSK Investigational Site
Roseville, California, 95661
United States
GSK Investigational Site
Aurora, Colorado, 80012
United States
GSK Investigational Site
Colorado Springs, Colorado, 80923
United States
GSK Investigational Site
Clearwater, Florida, 33756
United States
GSK Investigational Site
Gainesville, Florida, 32608
United States
GSK Investigational Site
Miami, Florida, 15801
United States
GSK Investigational Site
Miami, Florida, 33155
United States
GSK Investigational Site
Miami, Florida, 33173
United States
GSK Investigational Site
Miami, Florida, 33186
United States
GSK Investigational Site
Orlando, Florida, 32713
United States
GSK Investigational Site
Lawrenceville, Georgia, 30046
United States
GSK Investigational Site
Normal, Illinois, 61761
United States
GSK Investigational Site
Oak Lawn, Illinois, 60453
United States
GSK Investigational Site
Ames, Iowa, 50010
United States
GSK Investigational Site
Iowa City, Iowa, 52242
United States
GSK Investigational Site
Kansas City, Kansas, 66160
United States
GSK Investigational Site
Topeka, Kansas, 66606
United States
GSK Investigational Site
Wichita, Kansas, 67214
United States
GSK Investigational Site
Crowley, Louisiana, 70526
United States
GSK Investigational Site
Shreveport, Louisiana, 71115
United States
GSK Investigational Site
Annapolis, Maryland, 21404
United States
GSK Investigational Site
North Dartmouth, Massachusetts, 02747
United States
GSK Investigational Site
Ann Arbor, Michigan, 48109
United States
GSK Investigational Site
Ypsilanti, Michigan, 48197
United States
GSK Investigational Site
Columbia, Missouri, 65203
United States
GSK Investigational Site
Saint Louis, Missouri, 63110
United States
GSK Investigational Site
Saint Louis, Missouri, 63141
United States
GSK Investigational Site
Missoula, Montana, 59808
United States
GSK Investigational Site
Jersey City, New Jersey, 07304
United States
GSK Investigational Site
Bronx, New York, 10461
United States
GSK Investigational Site
Charlotte, North Carolina, 28277
United States
GSK Investigational Site
Raleigh, North Carolina, 28401
United States
GSK Investigational Site
Rocky Mount, North Carolina, 27804
United States
GSK Investigational Site
Salisbury, North Carolina, 28144
United States
GSK Investigational Site
Winston-Salem, North Carolina, 27103
United States
GSK Investigational Site
Columbus, Ohio, 43215
United States
GSK Investigational Site
Dayton, Ohio, 45417
United States
GSK Investigational Site
Oklahoma City, Oklahoma, 73104
United States
GSK Investigational Site
Tulsa, Oklahoma, 74136
United States
GSK Investigational Site
Medford, Oregon, 97504
United States
GSK Investigational Site
Portland, Oregon, 97202
United States
GSK Investigational Site
Philadelphia, Pennsylvania, 19140
United States
GSK Investigational Site
Warwick, Rhode Island, 02886
United States
GSK Investigational Site
Charleston, South Carolina, 29406
United States
GSK Investigational Site
Little River, South Carolina, 29566
United States
GSK Investigational Site
Mount Pleasant, South Carolina, 29464
United States
GSK Investigational Site
Rock Hill, South Carolina, 29732
United States
GSK Investigational Site
Bristol, Tennessee, 37620
United States
GSK Investigational Site
Knoxville, Tennessee, 37938
United States
GSK Investigational Site
Dallas, Texas, 75231-4307
United States
GSK Investigational Site
Houston, Texas, 77074
United States
GSK Investigational Site
Houston, Texas, 77401
United States
GSK Investigational Site
McKinney, Texas, 75069
United States
GSK Investigational Site
San Antonio, Texas, 78229
United States
GSK Investigational Site
Waco, Texas, 76712
United States
GSK Investigational Site
Salt Lake City, Utah, 84132
United States
GSK Investigational Site
Norfolk, Virginia, 23507
United States
GSK Investigational Site
Williamsburg, Virginia, 23188
United States
GSK Investigational Site
Bellevue, Washington, 68123
United States
GSK Investigational Site
Bellingham, Washington, 98225
United States

Collaborators and Investigators

Sponsor: Bellus Health Inc. - a GSK company

  • GSK Clinical Trials, STUDY_DIRECTOR, GlaxoSmithKline

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 Date2022-10-25
Study Completion Date2026-05-28

Study Record Updates

Study Start Date2022-10-25
Study Completion Date2026-05-28

Terms related to this study

Keywords Provided by Researchers

  • Respiration Disorders
  • Respiratory Tract Diseases
  • Signs and Symptoms, Respiratory
  • Cough
  • Chronic Cough

Additional Relevant MeSH Terms

  • Cough
  • Refractory Chronic Cough