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

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

Outcome

Outcome not reported

Stopped (Enrollment): “The study was prematurely stopped due to extensive challenges in patient recruitment. The Sponsor issued a notification of early study termination to all investigational sites and all external stakeholders.”

Drugs

Indications