drugset / Trial / NCT05018598

Step-up to Medium Strength Triple Therapy vs High Strength ICS/LABA in Adult Asthmatics Uncontrolled on Medium Strength ICS/LABA

NCT05018598

Phase 4 Terminated 320 enrolled Chiesi Farmaceutici S.p.A.
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

EvaluationDrugModalityDoseRoute
Comparator CHF 5993 Other / unclassified 100 ug Inhaled
Comparator CHF 5993 Other / unclassified 200 ug Inhaled
Comparator CHF1535 Unknown 200 ug Inhaled

Indications