Refractory Chronic Cough, Including Unexplained Chronic Cough
Conditions
Brief summary
24-hour cough frequency at Week 24 by a cough monitor in adult participants • Incidence of AEs and SAEs up to Week 24 • Incidence of AEMIs up to Week 24 • Incidence of study treatment discontinuations due to AEs and SAEs leading to study withdrawal up to Week 24 • Changes from Baseline in vital signs at Week 24, clinical laboratory values at Week 24 • Changes from Baseline in ECG values at Week 24
Detailed description
CS-VAS • Change from Baseline in CS-VAS at Week 24 • CS-VAS response at Week 24 Objective cough frequency recording • Awake cough frequency at Week 24 • 24-hour cough response from Baseline at Week 24 LCQ • Change from Baseline in the LCQ total score at Week 24 • LCQ response at Week 24
Interventions
Sponsors
Bellus Health Inc.
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 24-hour cough frequency at Week 24 by a cough monitor in adult participants • Incidence of AEs and SAEs up to Week 24 • Incidence of AEMIs up to Week 24 • Incidence of study treatment discontinuations due to AEs and SAEs leading to study withdrawal up to Week 24 • Changes from Baseline in vital signs at Week 24, clinical laboratory values at Week 24 • Changes from Baseline in ECG values at Week 24 | — |
Secondary
| Measure | Time frame |
|---|---|
| CS-VAS • Change from Baseline in CS-VAS at Week 24 • CS-VAS response at Week 24 Objective cough frequency recording • Awake cough frequency at Week 24 • 24-hour cough response from Baseline at Week 24 LCQ • Change from Baseline in the LCQ total score at Week 24 • LCQ response at Week 24 | — |
Countries
Czechia, Germany, Poland, Slovakia
Outcome results
None listed