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Evaluation of the Efficacy and Safety of BLU-5937 in Adults With Refractory Chronic Cough (SOOTHE)

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ClinicalTrials.gov Identifier: NCT04678206
Recruitment Status : Recruiting
First Posted : December 21, 2020
Last Update Posted : September 1, 2021
Sponsor:
Information provided by (Responsible Party):
Bellus Health Inc

Brief Summary:
This is a randomized, double-blind, placebo-controlled, parallel-arm, Phase 2b adaptive dose-finding study of BLU-5937 in participants with Refractory Chronic Cough (RCC).

Condition or disease Intervention/treatment Phase
Refractory Chronic Cough Drug: BLU-5937 Drug: Placebo Phase 2

Detailed Description:
The primary objective of this study is to determine the therapeutic dose of BLU-5937 in patients with refractory chronic cough by assessing the change from baseline to week 4 in the 24-hour cough frequency with BLU-5937 relative to placebo.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 300 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized, Adaptive, Double-Blind, Placebo-Controlled, Parallel-Arm, Phase 2b Study to Evaluate the Efficacy and Safety of Multiple Doses of BLU-5937 in Adult Participants With Refractory Chronic Cough
Actual Study Start Date : December 7, 2020
Estimated Primary Completion Date : September 2021
Estimated Study Completion Date : September 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cough

Arm Intervention/treatment
Experimental: BLU-5937 Dose A
BLU-5937 oral dose A twice a day.
Drug: BLU-5937
Oral administration of BLU-5937 Tablets

Experimental: BLU-5937 Dose B
BLU-5937 oral dose B twice a day.
Drug: BLU-5937
Oral administration of BLU-5937 Tablets

Experimental: BLU-5937 Dose C
BLU-5937 oral dose C 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

Experimental: BLU-5937 Dose A (Population with baseline cough < 25 coughs/hour)
BLU-5937 oral dose A twice a day.
Drug: BLU-5937
Oral administration of BLU-5937 Tablets

Placebo Comparator: Placebo (Population with baseline cough < 25 coughs/hour)
Matching Placebo for BLU-5937 oral dose twice a day.
Drug: Placebo
Oral administration of matching placebo for BLU-5937 Tablets




Primary Outcome Measures :
  1. Change from baseline in the 24-hour cough frequency [ Time Frame: Week 4 ]
    Assessed using an ambulatory cough monitor


Secondary Outcome Measures :
  1. Percentage of Participants with a Reduction from Baseline in the 24-hour Cough Frequency by ≥ 30%, 50% and 70% [ Time Frame: Week 4 ]
    Assessed using an ambulatory cough monitor

  2. Change from Baseline in Leicester Cough Questionnaire (LCQ) [ Time Frame: Week 4 ]
    The 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 effect of cough on 3 main 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.

  3. Change from baseline in cough severity [ Time Frame: Week 4 ]
    Assessed by Cough Severity Visual Analogue Scale [VAS] by the participant on a 100 mm visual analog scale where higher scores indicate worse severity.

  4. Incidence (% of subjects) of treatment-emergent adverse events (TEAEs) [ Time Frame: 2 Weeks after the last study medication intake ]
  5. Severity (mild, moderate, or severe) of treatment-emergent adverse events (TEAEs) [ Time Frame: 2 Weeks after the last study medication intake ]


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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04678206


Contacts
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Contact: Kristin Bartholomew 833-703-0708 SOOTHE@bellushealth.com
Contact: Margaret Garin, MD 833-703-0708 SOOTHE@bellushealth.com

Locations
Show Show 118 study locations
Sponsors and Collaborators
Bellus Health Inc
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Responsible Party: Bellus Health Inc
ClinicalTrials.gov Identifier: NCT04678206    
Other Study ID Numbers: BUS-P2-02
2020-004136-17 ( EudraCT Number )
First Posted: December 21, 2020    Key Record Dates
Last Update Posted: September 1, 2021
Last Verified: August 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Bellus Health Inc:
BLU-5937
Refractory Chronic Cough
P2X3 receptor antagonist
Additional relevant MeSH terms:
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Cough
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory