Asthma
Conditions
Brief summary
Annualized severe asthma exacerbation rate
Detailed description
Change in pre-bronchodilator Forced Expiratory Volume in the first second (FEV1), Annualized cumulative dose of systemic corticosteroid exposure to treat severe asthma exacerbations, Change in Asthma Control Questionnaire (ACQ-5), Proportion of participants achieving ACQ-5 <1.5, Change in pre-bronchodilator FEV1, Change in percent of predicted FEV1, Change in peak expiratory flow (PEF), Change in forced vital capacity (FVC), Change in forced expiratory flow (FEF) 25-75%, Change in FEV1:FVC ratio, Change in post-bronchodilator FEV1, Time to first severe exacerbation event, Proportion of participants achieving a 0.5-point improvement minimal clinically important difference (MCID) in ACQ-5, Incidence of Treatment-emergent adverse events (TEAEs)
Interventions
DRUGAdvair HFA 230mcg/21mcg
DRUGAdvair HFA 115 mcg/21 mcg
Sponsors
Regeneron Pharmaceuticals Inc.
Eligibility
Sex/Gender
All
Age
0 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Annualized severe asthma exacerbation rate | — |
Secondary
| Measure | Time frame |
|---|---|
| Change in pre-bronchodilator Forced Expiratory Volume in the first second (FEV1), Annualized cumulative dose of systemic corticosteroid exposure to treat severe asthma exacerbations, Change in Asthma Control Questionnaire (ACQ-5), Proportion of participants achieving ACQ-5 <1.5, Change in pre-bronchodilator FEV1, Change in percent of predicted FEV1, Change in peak expiratory flow (PEF), Change in forced vital capacity (FVC), Change in forced expiratory flow (FEF) 25-75%, Change in FEV1:FVC ratio, Change in post-bronchodilator FEV1, Time to first severe exacerbation event, Proportion of participants achieving a 0.5-point improvement minimal clinically important difference (MCID) in ACQ-5, Incidence of Treatment-emergent adverse events (TEAEs) | — |
Countries
Denmark, Germany, Poland
Outcome results
None listed