drugset / Trial / NCT07858123

Safety and Efficacy Comparison Between CHF5993 100/6 12.5µg pMDI to Seretide Evohaler 125/25µg pMDI in Adolescent Subjects With Asthma

NCT07858123 ↗

Phase 3 Not yet recruiting 700 enrolled Chiesi Farmaceutici S.p.A.
RandomizedParallel-groupQuadruple-blindTreatment

Summary

The CLI-05993AA5-06 study is an interventional study designed to investigate the safety and efficacy of a new experimental drug called CHF5993 pMDI compared to the currently approved Seretide 125 Evohaler pMDI in adolescent patients with uncontrolled asthma.

Timeline

Start
2026-11-16
Primary completion
2030-06-26
Completion
2030-06-26

Drugs

EvaluationDrugModalityDoseRoute
Comparator Fluticasone propionate Other / unclassified 125 ug Inhaled
Subject Formoterol Other / unclassified 6 ug Inhaled
Subject Glycopyrronium Unknown 12.5 ug Inhaled
Subject beclomethasone dipropionate Other / unclassified 100 ug Inhaled
Comparator salmeterol xinafoate Unknown 25 ug Inhaled

Indications