Cystic Fibrosis
Conditions
Brief summary
The primary endpoint in both trials is the average of the percent predicted forced expiratory volume in 1 second (ppFEV1) measurements taken after 4, 6 and 8 weeks of treatment.
Detailed description
• The course of efficacy parameters over 24 weeks (TP2 and TP3) of treatment in both groups • The average of the sweat chloride measurements taken after 4, 6 and 8 weeks of treatment • The average of the weight measurements taken after 4, 6 and 8 weeks of treatment • The average of the Cystic Fibrosis Questionnaire Revised (CFQ R) respiratory domain measurements taken after 4, 6 and 8 weeks of treatment
Sponsors
University Medical Center Utrecht
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary endpoint in both trials is the average of the percent predicted forced expiratory volume in 1 second (ppFEV1) measurements taken after 4, 6 and 8 weeks of treatment. | — |
Secondary
| Measure | Time frame |
|---|---|
| • The course of efficacy parameters over 24 weeks (TP2 and TP3) of treatment in both groups • The average of the sweat chloride measurements taken after 4, 6 and 8 weeks of treatment • The average of the weight measurements taken after 4, 6 and 8 weeks of treatment • The average of the Cystic Fibrosis Questionnaire Revised (CFQ R) respiratory domain measurements taken after 4, 6 and 8 weeks of treatment | — |
Countries
Belgium, Czechia, Denmark, Germany, Italy, Netherlands, Portugal, Spain, Sweden
Outcome results
None listed