MGR001 / Advair Diskus Local Equivalence Study in Asthma

Phase 3 Completed 1128 enrolled Mylan Pharma UK Ltd.

RandomizedParallel-groupQuadruple-blindTreatment

Summary

The purpose of this study is to determine whether MGR001 is equivalent to Advair Diskus when administered by inhalation in adult asthma patients

Timeline

Start: 2014-10
Primary completion: 2015-07
Completion: 2015-07

Outcome

Met primary endpoint

paper T and R significantly increased day 1 FEV1 area under the effect curve over 12 hours of the change from baseline (AUC[0-12]) and day 29 trough FEV1 over placebo PMID 31634023 ↗

paper indicating that T and R were bioequivalent for both co-primary endpoints. PMID 31634023 ↗

Publications

Results Ng D, Kerwin EM, White MV, Miller SD, Haughie S, Ward JK, Allan R. Clinical Bioequivalence of Wixela Inhub and Advair Diskus in Adults With Asthma. J Aerosol Med Pulm Drug Deliv. 2020 Apr;33(2):99-107. doi: 10.1089/jamp.2019.1547. Epub 2019 Oct 31.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Fluticasone propionate	Other / unclassified	100 ug	Inhaled
Subject	salmeterol xinafoate	Unknown	50 ug	Inhaled