Skip to main content
OpenTrials
Completed

NCT Number: NCT04678206

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

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).

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Refractory Chronic Cough Chronic Cough Cough Pathological Conditions, Signs and Symptoms Respiration Disorders Respiratory Tract Diseases Signs and Symptoms Signs and Symptoms, Respiratory

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

McMaster University Medical Centre, Hamilton, Ontario, Canada

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

BLU-5937

Drug

Oral administration of BLU-5937 Tablets

Placebo

Drug

Oral administration of matching placebo for BLU-5937 Tablets

Primary outcomes

  1. Change from baseline in the 24-hour cough frequency

    Time frame: Week 4

    Assessed using an ambulatory cough monitor

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Bellus Health Inc. - a GSK company

Industry

Registry information

Official study 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

Acronym: SOOTHE

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Dec 21, 2020
Registry last updated
Dec 13, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.