An Open, Randomised, Parallel Group Multicentre Study to Compare the Efficacy and Safety of Flutiform® pMDI vs Fluticasone pMDI Plus Formoterol DPI in Adolescent and Adult Subjects With Mild to Moderate-severe Persistent, Reversible Asthma

Phase 3 Completed 227 enrolled Mundipharma Research Limited

RandomizedParallel-groupOpen-labelTreatment

Flutiform® compared with the individual components Flixotide® (Fluticasone) and Foradil® (Formoterol) in adolescent and adult patients.

Met primary endpoint

paper The lower limit of the 95% CI (-0.148 L) was above the non-inferiority threshold of ≥-0.2 L. PMID 23368897 ↗

Evaluation	Drug	Modality	Dose	Route
Comparator	Fluticasone	Other / unclassified	100 ug	Inhaled
Comparator	Fluticasone	Other / unclassified	250 ug	Inhaled
Comparator	Formoterol	Other / unclassified	12 ug	Inhaled
Subject	fluticasone/formoterol	Unknown	—	Inhaled