Single Blind Cross-over Dose Response Study in Subjects of Two Inhalers of Salmeterol and Fluticasone Propionate

Summary

The purpose of this study is to test the body's response to several doses of two different inhalation products in healthy volunteers.

Timeline

Start

2014-07

Primary completion

2014-10

Completion

2014-12

Outcome

Met primary endpoint

paper Safety equivalence was shown by relative potency analysis for primary endpoints of maximum heart rate and maximum QTcB PMID 28626983 ↗

paper since the 90% confidence intervals for both endpoints were within the acceptance limit of (0.67, 1.50). PMID 28626983 ↗

Publications

• Results Harrison LI, Sessions V, Wiggenhorn CJ, Chalmers D, Leung P, Efthimiou J. Comparison of systemic pharmacodynamic effects of two combination pressurized metered dose inhalers that deliver salmeterol and fluticasone propionate. Br J Clin Pharmacol. 2017 Nov;83(11):2377-2385. doi: 10.1111/bcp.13349. Epub 2017 Aug 1.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Fluticasone propionate	Other / unclassified	250 ug	Other
Subject	Fluticasone propionate	Other / unclassified	750 ug	Other
Subject	Fluticasone propionate	Other / unclassified	1500 ug	Other
Subject	Salmeterol	Other / unclassified	50 ug	Other
Subject	Salmeterol	Other / unclassified	150 ug	Other
Subject	Salmeterol	Other / unclassified	300 ug	Other

Indications

No indication recorded.