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

PHASE3RECRUITING

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

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Study details:

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.

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Eligibility criteria

Researchers look for people who fit a certain description, called eligibility criteria. See if you qualify.

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
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    Eligibility

    Age eligible for study : 18 and older

    Healthy volunteers accepted : No

    Gender eligible for study: All

    Things to know

    Study dates

    Study start: 2023-01-13

    Primary completion: 2025-09-01

    Study completion finish: 2026-06-01

    study type

    Study type

    TREATMENT

    phase

    Phase

      PHASE3

    trial

    Trial ID

    NCT05600777

    Intervention or treatment

    DRUG: BLU-5937

    DRUG: Placebo

    Conditions

    • Refractory Chronic Cough
    Image related to Refractory Chronic Cough
    • Condition: Refractory Chronic Cough

    • DRUG: BLU-5937 and other drugs

    • Coffs Harbour, New South Wales, Australia and more

    • Sponsor: Bellus Health Inc. - a GSK company

    Find a site

    Closest Location:

    Northside Health

    Research sites nearby

    Select from list below to view details:

    • Northside Health

      Coffs Harbour, New South Wales, Australia

    • John Hunter Hospital

      New Lambton Heights, New South Wales, Australia

    • The Prince Charles Hospital

      Chermside, Queensland, Australia

    • Royal Adelaide Hospital

      Adelaide, South Australia, Australia

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    Study Plan

    This section provides details of the study plan, including how the study is designed and what the study is measuring.

    How is the study designed?

    Participant Group/ArmIntervention/Treatment
    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

    What is the study measuring?

    Primary outcome

    Primary Outcome MeasurePrimary Outcome DescriptionPrimary Outcome Time Frame
    24-Hour Cough FrequencyAssessed using an ambulatory cough monitorWeek 24

    Secondary outcome

    Secondary Outcome MeasureSecondary Outcome DescriptionSecondary Outcome Time Frame
    Change from Baseline in Cough Severity Visual Analogue Scale at Week 24Assessed by Cough Severity Visual Analogue Scale \[VAS\] by the participant on a 100 mm visual analog scale where higher scores indicate greater severity.Baseline, Week 24
    Percentage of Participants With ≥ 30mm Reduction, ≥ 20mm Reduction From Baseline in Cough Severity Visual Analog Scale (VAS) at Week 24Assessed by Cough Severity Visual Analogue Scale \[VAS\] by the participant on a 100 mm visual analog scale where higher scores indicate greater severity.Baseline, Week 24
    Percentage of Participants With ≥30%, ≥50%, and ≥70% Reduction From Baseline in 24-Hour Cough Frequency at Week 24Assessed using an ambulatory cough monitorBaseline, Week 24
    Change from Baseline in the Leicester Cough Questionnaire (LCQ) Total Score at Week 24The LCQ is a patient-reported quality of life (QOL) measure of chronic cough. The questionnaire consists of 19 items to which the patient responds on a 7-point Likert response scale (from 1 to 7). Each item assesses symptoms during cough and the impact of cough on 3 domains: physical, psychological, and social. Domain scores range from 1-7, and the total score ranges from 3 - 21; a higher score indicates a better quality of life.Baseline, Week 24
    Percentage of Participants With a ≥1.3-point Increase From Baseline in Leicester Cough Questionnaire (LCQ) Total Score at Week 24The LCQ is a patient-reported quality of life (QOL) measure of chronic cough. The questionnaire consists of 19 items to which the patient responds on a 7-point Likert response scale (from 1 to 7). Each item assesses symptoms during cough and the impact of cough on 3 domains: physical, psychological, and social. Domain scores range from 1-7, and the total score ranges from 3 - 21; a higher score indicates a better quality of life.Baseline, Week 24

    Frequently Asked Questions

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    References

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

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