Asthma
Conditions
Brief summary
Baseline-adjusted post-dose forced expiratory volume in one second (FEV1) area under the effect curve from time zero to 6 hours (AUEC0-6hr) over 4 weeks (FEV1 AUEC0-6hr), Baseline-adjusted trough FEV1at week 4
Detailed description
Time to 15% improvement from baseline FEV1 post-dose on day 1., Time to 12% improvement from baseline FEV1 post-dose on day 1., Duration of 15% increase in FEV1 from baseline post-dose on day 1, Asthma Control Questionnaire-6 (ACQ-6) response at week 4 defined as achieving a decrease in score from baseline value of at least 0.5 for participants with a baseline ACQ-6 score of ≥1.5, Asthma Control Test (ACT) score response at week 4 defined as achieving an increase in score from baseline value of at least 3, Occurrence of adverse events during the trial., Occurrence of serious adverse events during the trial., Treatment withdrawal due to treatment-emergent adverse events., Plasma concentration of Fp and ABS at the specified timepoints
Interventions
Sponsors
Eligibility
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Baseline-adjusted post-dose forced expiratory volume in one second (FEV1) area under the effect curve from time zero to 6 hours (AUEC0-6hr) over 4 weeks (FEV1 AUEC0-6hr), Baseline-adjusted trough FEV1at week 4 | — |
Secondary
| Measure | Time frame |
|---|---|
| Time to 15% improvement from baseline FEV1 post-dose on day 1., Time to 12% improvement from baseline FEV1 post-dose on day 1., Duration of 15% increase in FEV1 from baseline post-dose on day 1, Asthma Control Questionnaire-6 (ACQ-6) response at week 4 defined as achieving a decrease in score from baseline value of at least 0.5 for participants with a baseline ACQ-6 score of ≥1.5, Asthma Control Test (ACT) score response at week 4 defined as achieving an increase in score from baseline value of at least 3, Occurrence of adverse events during the trial., Occurrence of serious adverse events during the trial., Treatment withdrawal due to treatment-emergent adverse events., Plasma concentration of Fp and ABS at the specified timepoints | — |
Countries
Bulgaria, Czechia, Germany, Poland, Romania, Slovakia