Efficacy and Safety Study of FP MDPI Compared With FS MDPI in Adolescent and Adult Patients With Persistent Asthma

Summary

The primary objective of this study was to evaluate the efficacy of fluticasone propionate (Fp) multidose dry powder inhaler (MDPI) and fluticasone propionate/salmeterol xinafoate (FS) MDPI when administered over 12 weeks in patients 12 years of age and older with persistent asthma.

Timeline

Start

2014-06

Primary completion

2015-09

Completion

2015-09

Outcome

Met primary endpoint

paper Fp MDPI and FS MDPI significantly improved both primary end points compared with placebo (p < 0.05). PMID 28639542 ↗

registry analysis (unspecified test); FS MDPI 200 / 12.5 mcg vs Fp MDPI 200 mcg; p = 0.0009; LSM difference 0.179 (95% CI 0.074 to 0.285); ANCOVA; NCT02141854 ↗

Publications

• Sher LD, Yiu G, Sakov A, Liu S, Caracta CF. Fluticasone propionate and fluticasone propionate/salmeterol multidose dry powder inhalers compared with placebo for persistent asthma. Allergy Asthma Proc. 2017 Sep 21;38(5):343-353. doi: 10.2500/aap.2017.38.4069. Epub 2017 Jun 21.
• Miller DS, Yiu G, Hellriegel ET, Steinfeld J. Dose-ranging study of salmeterol using a novel fluticasone propionate/salmeterol multidose dry powder inhaler in patients with persistent asthma. Allergy Asthma Proc. 2016 Jul;37(4):291-301. doi: 10.2500/aap.2016.37.3963. Epub 2016 May 27.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Fluticasone propionate	Other / unclassified	100 ug	Inhaled
Subject	Fluticasone propionate	Other / unclassified	200 ug	Inhaled
Background	salmeterol xinafoate	Unknown	12.5 ug	Inhaled
Background	Salbutamol	Unknown	—	Inhaled
Background	salmeterol xinafoate	Unknown	—	Inhaled

Indications