drugset / Trial / NCT05018598
Step-up to Medium Strength Triple Therapy vs High Strength ICS/LABA in Adult Asthmatics Uncontrolled on Medium Strength ICS/LABA
RandomizedParallel-groupQuadruple-blindTreatment
Summary
The purpose of this phase IV Study is to compare the efficacy of CHF5993 (BDP/FF/GB 100/6/12.5 pMDI) on uncontrolled asthma subjects, versus CHF1535 (BDP/FF 200/6 pMDI). The open label extension part aims to assess the proportion of subjects whose asthma remains or becomes adequately controlled..
Timeline
- Start
- 2022-02-25
- Primary completion
- 2024-04-16
- Completion
- 2024-04-16
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | CHF 5993 | Other / unclassified | 100 ug | Inhaled |
| Comparator | CHF 5993 | Other / unclassified | 200 ug | Inhaled |
| Comparator | CHF1535 | Unknown | 200 ug | Inhaled |