Asthma
Conditions
Brief summary
Proportion of subjects who satisfy any of the following LOAC criteria: - ≥30% reduction in morning PEF from baseline on 2 consecutive days - ≥6 additional reliever inhalations of SABA in a 24-hour period relative to abseline on 2 consecutive days - Increase by a factor of 4 or more in the most recent dose of ICS - Exacerbation of asthma requiring systemic CS. - Exacerbation of asthma - related AE that requires a hospitalization or emergency room visit
Detailed description
Frequency of treatment-emergent adverse events, Time to a LOAC event, Change in forced expiratory volume in 1 second (FEV1) at Day 99 (Week 14) and at each interval visit after treatment with RPT193 compared to baseline, Change in Questionnaire score at Day 99 (Week 14) and at each interval visit after treatment with RPT193 compared to baseline, Change in PEF at Day 99 (Week 14) and at each interval visit after treatment with RPT193 compared to baseline, Change in reliever bronchodilator use at Day 99 (Week 14) and at each interval visit after treatment with RPT193 compared to baseline, Change in fractional exhaled nitric oxide (FeNO) at Day 99 (Week 14) and at each interval visit after treatment with RPT193 compared to baseline, Change in Questionnaire at Day 99 (Week 14) and at each interval visit after treatment with RPT193 compared to baseline, Change in FEV1 from Day 99 to 140 (Weeks 14 to 20), Change in FEV1 from Day 43 to 98 (Weeks 6 to 14)
Interventions
Sponsors
Eligibility
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion of subjects who satisfy any of the following LOAC criteria: - ≥30% reduction in morning PEF from baseline on 2 consecutive days - ≥6 additional reliever inhalations of SABA in a 24-hour period relative to abseline on 2 consecutive days - Increase by a factor of 4 or more in the most recent dose of ICS - Exacerbation of asthma requiring systemic CS. - Exacerbation of asthma - related AE that requires a hospitalization or emergency room visit | — |
Secondary
| Measure | Time frame |
|---|---|
| Frequency of treatment-emergent adverse events, Time to a LOAC event, Change in forced expiratory volume in 1 second (FEV1) at Day 99 (Week 14) and at each interval visit after treatment with RPT193 compared to baseline, Change in Questionnaire score at Day 99 (Week 14) and at each interval visit after treatment with RPT193 compared to baseline, Change in PEF at Day 99 (Week 14) and at each interval visit after treatment with RPT193 compared to baseline, Change in reliever bronchodilator use at Day 99 (Week 14) and at each interval visit after treatment with RPT193 compared to baseline, Change in fractional exhaled nitric oxide (FeNO) at Day 99 (Week 14) and at each interval visit after treatment with RPT193 compared to baseline, Change in Questionnaire at Day 99 (Week 14) and at each interval visit after treatment with RPT193 compared to baseline, Change in FEV1 from Day 99 to 140 (Weeks 14 to 20), Change in FEV1 from Day 43 to 98 (Weeks 6 to 14) | — |
Countries
Bulgaria, Czechia, Poland