Trials Today

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

Purpose

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

Condition

Refractory Chronic Cough

Eligibility

Eligible Ages: Between 18 Years and 80 Years
Eligible Genders: All
Accepts Healthy Volunteers: No

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

Study Design

Phase: Phase 3
Study Type: Interventional
Allocation: Randomized
Intervention Model: Parallel Assignment
Primary Purpose: Treatment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Arm Groups

Arm	Description	Assigned Intervention
Experimental BLU-5937 25 mg	BLU-5937 oral dose 25 mg twice a day.	Drug: BLU-5937 Oral administration of BLU-5937 Tablets
Experimental BLU-5937 50 mg	BLU-5937 oral dose 50 mg twice a day.	Drug: BLU-5937 Oral administration of BLU-5937 Tablets
Placebo Comparator Placebo	Matching Placebo for BLU-5937 oral dose twice a day.	Drug: Placebo Oral administration of matching placebo for BLU-5937 Tablets

Recruiting Locations

G & L Research, LLC
Gulf Shores, Alabama 36547

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

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

Paradigm Clinical Research Centers, Inc.
Redding, California 96001

Precision Research Institute, LLC
San Diego, California 92114

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

Colorado Allergy and Asthma Centers, PC
Denver, Colorado 80230

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

Savin Medical Group LLC
Miami Lakes, Florida 33014

Destin Pulmonary Critical Care, PLLS.
Santa Rosa Beach, Florida 32459

Lenus Research & Medical Group
Sweetwater, Florida 33172

In-Quest Medical Research, LLC
Norcross, Georgia 30071

The Iowa Clinic, PC
Ankeny, Iowa 50023

Minnesota Lung Center
Edina, Minnesota 55435

Mayo Clinic - Rochester
Rochester, Minnesota 55905

Minnesota Lung Center
Woodbury, Minnesota 55125

The Clinical Research Center, LLC
Saint Louis, Missouri 63141

Creighton University
Omaha, Nebraska 68124

ActivMed Practices & Research, LLC
Portsmouth, New Hampshire 03801

PMG Research of Charlotte, LLC
Charlotte, North Carolina 28209

Clinical Research of Gastonia
Gastonia, North Carolina 28054

Accellacare
Winston-Salem, North Carolina 27103

Optimed Research, LTD
Columbus, Ohio 43235

Pharmacorp Clinical Trials, Inc.
Charleston, South Carolina 29412

Clinical Trials Center of Middle Tennessee
Franklin, Tennessee 37067

Houston Pulmonary, Sleep, Allergy and Asthma Associates
Cypress, Texas 77429

Quality Assurance Research Center
San Antonio, Texas 78207

AMR Norfolk, Formerly Tidewater Associates, an AMR Company
Norfolk, Virginia 23507

More Details

NCT ID: NCT05600777
Status: Recruiting
Sponsor: Bellus Health Inc. - a GSK company

Study Contact

US GSK Clinical Trials call Center
877-379-3718
GSKClinicalSupportHD@gsk.com

Detailed Description

The primary efficacy objective is to assess the effect of BLU-5937 on 24-hour cough frequency in adults with refractory chronic cough (including unexplained chronic cough) at 24 weeks.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.