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BLU-5937 for Chronic Cough (CALM-1 Trial)

Phase 3
Recruiting
Research Sponsored by Bellus Health Inc. - a GSK company
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Refractory chronic cough (including unexplained chronic cough) for at least one year
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up week 12
Awards & highlights

CALM-1 Trial Summary

This trial will study a new drug for chronic, uncontrollable coughing.

Who is the study for?
Adults with a persistent cough lasting over a year that hasn't improved with treatment can join. They must be able to consent and, if they can have children, use effective birth control during the study and for two weeks after. People who've abused substances recently, participated in BLU-5937 trials before, had certain infections or cancers, smoke currently or quit recently, or have specific lung diseases cannot participate.Check my eligibility
What is being tested?
The trial is testing BLU-5937's effectiveness and safety against a placebo over one year in adults with refractory chronic cough. Participants will randomly receive either the actual drug or a placebo without knowing which one they're getting (double-blind).See study design
What are the potential side effects?
While specific side effects of BLU-5937 are not listed here, common side effects from medications like this may include headache, nausea, dizziness or allergic reactions. The exact side effects will be monitored throughout the trial.

CALM-1 Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I have had a chronic cough for at least one year that hasn't improved with treatment.

CALM-1 Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~week 12
This trial's timeline: 3 weeks for screening, Varies for treatment, and week 12 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Coughing
Secondary outcome measures
Change from Baseline in Cough Severity Visual Analogue Scale at Week 12
Change from Baseline in the Leicester Cough Questionnaire (LCQ) Total Score at Week 12
Percentage of Participants With a ≥1.3-point Increase From Baseline in Leicester Cough Questionnaire (LCQ) Total Score at Week 12
+2 more

CALM-1 Trial Design

3Treatment groups
Experimental Treatment
Placebo Group
Group I: BLU-5937 50 mgExperimental Treatment1 Intervention
BLU-5937 oral dose 50 mg twice a day.
Group II: BLU-5937 25 mgExperimental Treatment1 Intervention
BLU-5937 oral dose 25 mg twice a day.
Group III: PlaceboPlacebo Group1 Intervention
Matching Placebo for BLU-5937 oral dose twice a day.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
BLU-5937
2021
Completed Phase 2
~580

Find a Location

Who is running the clinical trial?

Bellus Health Inc. - a GSK companyLead Sponsor
17 Previous Clinical Trials
4,513 Total Patients Enrolled
3 Trials studying Chronic Cough
1,203 Patients Enrolled for Chronic Cough
Bellus Health IncLead Sponsor
15 Previous Clinical Trials
4,447 Total Patients Enrolled
3 Trials studying Chronic Cough
1,203 Patients Enrolled for Chronic Cough

Media Library

BLU-5937 (Other) Clinical Trial Eligibility Overview. Trial Name: NCT05599191 — Phase 3
Chronic Cough Research Study Groups: BLU-5937 25 mg, BLU-5937 50 mg, Placebo
Chronic Cough Clinical Trial 2023: BLU-5937 Highlights & Side Effects. Trial Name: NCT05599191 — Phase 3
BLU-5937 (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05599191 — Phase 3
Chronic Cough Patient Testimony for trial: Trial Name: NCT05599191 — Phase 3

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are older individuals able to participate in this clinical research?

"This trial includes all patients that are aged between 18 and 80 years old."

Answered by AI

Are people with the qualifying condition able to enroll in this study right now?

"That is correct. The clinical trial is recruiting patients and was last updated on October 31st, 2022. The study is looking for 675 participants total, who will be seen at 7 different locations."

Answered by AI

Could you please elaborate on the potential dangers of BLU-5937 50 mg for patients?

"BLU-5937 50 mg is in Phase 3 of clinical trials, meaning that there is both some evidence of efficacy and multiple rounds of data supporting safety. Consequently, our team at Power estimates the safety of BLU-5937 50 mg to be a 3."

Answered by AI

Could I enroll in this experiment?

"This trial is looking for 675 participants who have been coughing and are between 18-80 years old."

Answered by AI

Who else is applying?

What state do they live in?
Ohio
Texas
What portion of applicants met pre-screening criteria?
Met criteria
Did not meet criteria
How many prior treatments have patients received?
0
3+
What site did they apply to?
Remington-Davis, Inc.
Gwinnett Pulmonary Group P.C.
PMG Research of Raleigh

Why did patients apply to this trial?

I am disabled and this gives me an opportunity to help others and possibly get some answers for myself as well.
PatientReceived 1 prior treatment
~388 spots leftby Sep 2025