Refractory Chronic Cough, Including Unexplained Chronic Cough
Conditions
Brief summary
24-hour cough frequency at Week 12 by a cough monitor. • Incidence of AEs and SAEs up to Week 52 • Incidence of AEMIs up to Week 52 • Occurrences of study treatment discontinuations due to AEs and SAEs up to Week 52 • Occurrences of AEs and SAEs leading to study withdrawal up to Week 52
Detailed description
CS-VAS • Change from Baseline in CS-VAS at Week 12 • CS-VAS response at Week 12 Objective cough frequency recording • Awake cough frequency at Week 12 • 24-hour cough response at Week 12 LCQ • Change from Baseline in the LCQ total score at Week 12 • LCQ response at Week 12
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 12 by a cough monitor. • Incidence of AEs and SAEs up to Week 52 • Incidence of AEMIs up to Week 52 • Occurrences of study treatment discontinuations due to AEs and SAEs up to Week 52 • Occurrences of AEs and SAEs leading to study withdrawal up to Week 52 | — |
Secondary
| Measure | Time frame |
|---|---|
| CS-VAS • Change from Baseline in CS-VAS at Week 12 • CS-VAS response at Week 12 Objective cough frequency recording • Awake cough frequency at Week 12 • 24-hour cough response at Week 12 LCQ • Change from Baseline in the LCQ total score at Week 12 • LCQ response at Week 12 | — |
Countries
Belgium, France, Hungary, Netherlands, Poland, Spain
Outcome results
None listed