Asthma
Conditions
Brief summary
1. Annualized rate of clinically significant exacerbations over the treatment period.
Detailed description
1. Clinical remission at 2 years (104 weeks), defined as: • No clinically significant asthma exacerbations during the first 2 years of the treatment period and • No maintenance OCS for asthma at 2 years and • Well controlled asthma based on an ACT ≥20 at 2 years and • No deterioration of lung function. Deterioration is defined as a reduction in post-BD FEV1 of more than 0 ml at 2 years compared to baseline., 2. Change from baseline in AQLQ total overall score at 2 years, in participants with baseline ACQ-5 ≥1.5., 3. Change from baseline in ACQ-5 score at 2 years, in participants with baseline ACQ-5 ≥1.5., 4. Change from baseline of post-BD FEV1 at 2 years., 5. Change from baseline of pre-BD FEV1 at 2 years.
Interventions
Sponsors
Eligibility
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Annualized rate of clinically significant exacerbations over the treatment period. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Clinical remission at 2 years (104 weeks), defined as: • No clinically significant asthma exacerbations during the first 2 years of the treatment period and • No maintenance OCS for asthma at 2 years and • Well controlled asthma based on an ACT ≥20 at 2 years and • No deterioration of lung function. Deterioration is defined as a reduction in post-BD FEV1 of more than 0 ml at 2 years compared to baseline., 2. Change from baseline in AQLQ total overall score at 2 years, in participants with baseline ACQ-5 ≥1.5., 3. Change from baseline in ACQ-5 score at 2 years, in participants with baseline ACQ-5 ≥1.5., 4. Change from baseline of post-BD FEV1 at 2 years., 5. Change from baseline of pre-BD FEV1 at 2 years. | — |