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

Description

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

Conditions

Refractory Chronic Cough

Talk to us

Study Overview

On this page

Study Details

Study overview

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

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

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

Condition
Refractory Chronic Cough
Intervention / Treatment

-

Contacts and Locations

Gulf Shores

G & L Research, LLC, Gulf Shores, Alabama, United States, 36547

Peoria

Phoenix Medical Research Institute, LLC, Peoria, Arizona, United States, 85381

Los Angeles

California Allergy & Asthma Medical Group Inc., Los Angeles, California, United States, 90025

Los Angeles

Southern California Institute For Respiratory Diseases, Inc., Los Angeles, California, United States, 90048

Redding

Paradigm Clinical Research Centers, Inc., Redding, California, United States, 96001

San Diego

Precision Research Institute, LLC, San Diego, California, United States, 92114

San Jose

Allergy & Asthma Associates of Santa Clara Valley, San Jose, California, United States, 95117

Denver

Colorado Allergy and Asthma Centers, PC, Denver, Colorado, United States, 80230

Leesburg

Clinical Site Partners, LLC d/b/a CSP Leesburg, Leesburg, Florida, United States, 34748

Miami Lakes

Savin Medical Group LLC, Miami Lakes, Florida, United States, 33014

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.

For general information about clinical research, read Learn About Studies.

Eligibility 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
  • * 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

Ages Eligible for Study

18 Years to 80 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Bellus Health Inc. - a GSK company,

Study Record Dates

2026-06