Non-Cystic Fibrosis Bronchiectasis
Conditions
Brief summary
Rate of protocol-defined pulmonary exacerbations over the study interval (number of events per subject-year).
Detailed description
Time to the onset of the first protocol-defined pulmonary exacerbation over the study interval. Mean change from Baseline at Week 24 in: E-RS Cough and Sputum Domain, SGRQ, QOL-B Respiratory Symptoms Domain, CAAT, Percent of the predicted FEV1, Mean change from Baseline at Weeks 6 and 12 in: E-RS Cough and Sputum Domain, SGRQ, QOL-B Respiratory Symptoms Domain, CAAT, Percent of the predicted FEV1 (Wk 12 only) Mean change from Baseline at Weeks 6, 12, and 24 in: QOL-B total score
Interventions
DRUGEnsifentrine inhalation suspension
DRUGThe placebo is the same as the ensifentrine suspension except that the active ensifentrine
ingredient is omitted (i.e.
DRUGit consists of phosphate buffered saline and surfactants only); it
is also supplied as a single unit-dose LDPE translucent ampule overwrapped in a foil
pouch
Sponsors
Verona Pharma PLC
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Rate of protocol-defined pulmonary exacerbations over the study interval (number of events per subject-year). | — |
Secondary
| Measure | Time frame |
|---|---|
| Time to the onset of the first protocol-defined pulmonary exacerbation over the study interval. Mean change from Baseline at Week 24 in: E-RS Cough and Sputum Domain, SGRQ, QOL-B Respiratory Symptoms Domain, CAAT, Percent of the predicted FEV1, Mean change from Baseline at Weeks 6 and 12 in: E-RS Cough and Sputum Domain, SGRQ, QOL-B Respiratory Symptoms Domain, CAAT, Percent of the predicted FEV1 (Wk 12 only) Mean change from Baseline at Weeks 6, 12, and 24 in: QOL-B total score | — |
Countries
Italy, Spain
Outcome results
None listed