Refractory Chronic Cough
Conditions
Keywords
BLU-5937, Refractory Chronic Cough, P2X3 receptor antagonist
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).
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.
Interventions
DRUGBLU-5937
Oral administration of BLU-5937 Tablets
DRUGPlacebo
Oral administration of matching placebo for BLU-5937 Tablets
Sponsors
Bellus Health Inc. - a GSK company
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Intervention model description
Parallel Assignment
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change from baseline in the 24-hour cough frequency | Week 4 | Assessed using an ambulatory cough monitor |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants with a Reduction from Baseline in the 24-hour Cough Frequency by ≥ 30%, 50% and 70% | Week 4 | Assessed using an ambulatory cough monitor |
| Change from Baseline in Leicester Cough Questionnaire (LCQ) | 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. |
| Change from baseline in cough severity | 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. |
| Incidence (% of subjects) of treatment-emergent adverse events (TEAEs) | 2 Weeks after the last study medication intake | — |
| Severity (mild, moderate, or severe) of treatment-emergent adverse events (TEAEs) | 2 Weeks after the last study medication intake | — |
Countries
Canada, Czechia, Germany, Hungary, Poland, United Kingdom, United States
Outcome results
None listed