Refractory or Unexplained Chronic Cough
Conditions
Brief summary
Change in 24-hour Coughs per hour from Baseline to Day 28 (based on VitaloJAK® Cough Counts)
Detailed description
Change in Awake coughs per hour from Baseline to Day 28 (based on VitaloJAK® Cough Counts), Change in the Cough Severity Visual Analog Scale (CS-VAS) from Baseline to Day 28, Change in the Urge to Cough Visual Analog Scale (UC-VAS) from Baseline to Day 28, Change in the Leicester Cough Questionnaire (LCQ) from Baseline to Day 28, Patient Global Impressions of Improvement (PGI-I) score at Day 28, Incidence and severity of adverse events (AEs) and serious adverse events (SAEs)
Interventions
DRUGTaplucainium Inhalation Powder
DRUGPlacebo is a blend of inhalation grade lactose with arginine
DRUGit is taste masked to the active ingredient to minimize unblinding.
Sponsors
Nocion Therapeutics Inc.
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in 24-hour Coughs per hour from Baseline to Day 28 (based on VitaloJAK® Cough Counts) | — |
Secondary
| Measure | Time frame |
|---|---|
| Change in Awake coughs per hour from Baseline to Day 28 (based on VitaloJAK® Cough Counts), Change in the Cough Severity Visual Analog Scale (CS-VAS) from Baseline to Day 28, Change in the Urge to Cough Visual Analog Scale (UC-VAS) from Baseline to Day 28, Change in the Leicester Cough Questionnaire (LCQ) from Baseline to Day 28, Patient Global Impressions of Improvement (PGI-I) score at Day 28, Incidence and severity of adverse events (AEs) and serious adverse events (SAEs) | — |
Countries
Belgium, Germany, Poland
Outcome results
None listed