Clinical Efficacy Study of Salmeterol Xinafoate/Fluticasone Propionate in Asthma

Summary

This is a study to establish the equivalence of OT329 Solis and Advair Diskus when administered by inhalation in patients with asthma.

Timeline

Start

2014-09

Primary completion

2015-05

Completion

2015-07

Outcome

Met primary endpoint

paper OT329 SOLIS and ADVAIR DISKUS were bioequivalent at Day 1 PMID 27849125 ↗

paper Likewise, the products were bioequivalent at Week 4 with a trough FEV1 test/reference ratio of 105% (90% CI = 90-119). PMID 27849125 ↗

Publications

• Longphre MV, Getz EB, Fuller R. Clinical Bioequivalence of OT329 SOLIS and ADVAIR DISKUS in Adults with Asthma. Ann Am Thorac Soc. 2017 Feb;14(2):182-189. doi: 10.1513/AnnalsATS.201606-436OC.

Drugs

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

Indications