Asthma
Conditions
Brief summary
Time to first severe (CAE) clinical asthma exacerbation (a worsening of asthma).
Detailed description
The key efficacy endpoints: - annualized severe CAE rate '- total annualized SCS exposure over the treatment period, - Asthma Control Questionnaire-5 (ACQ-5) response at week 24, defined as achieving a decrease in score from baseline value of at least 0.5, - Asthma Quality of Life Questionnaire + 12 (AQLQ+12) response at week 24, defined as achieving an increase from baseline of at least 0.5, Safety/Tolerability endpoints: '- occurrence of adverse events during the study '- occurrence of serious adverse events during the study '- study withdrawal due to treatment-emergent adverse events
Interventions
Sponsors
Teva Branded Pharmaceutical Products R&D LLC
Eligibility
Sex/Gender
All
Age
0 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Time to first severe (CAE) clinical asthma exacerbation (a worsening of asthma). | — |
Secondary
| Measure | Time frame |
|---|---|
| The key efficacy endpoints: - annualized severe CAE rate '- total annualized SCS exposure over the treatment period, - Asthma Control Questionnaire-5 (ACQ-5) response at week 24, defined as achieving a decrease in score from baseline value of at least 0.5, - Asthma Quality of Life Questionnaire + 12 (AQLQ+12) response at week 24, defined as achieving an increase from baseline of at least 0.5, Safety/Tolerability endpoints: '- occurrence of adverse events during the study '- occurrence of serious adverse events during the study '- study withdrawal due to treatment-emergent adverse events | — |
Countries
Bulgaria, Czechia, Denmark, Germany, Greece, Hungary, Italy, Latvia, Poland, Romania, Slovakia, Spain
Outcome results
None listed