A Study of the Effectiveness and Safety of Different Doses of Fluticasone Propionate Taken From a Dry Powder Inhaler (Puffer) in Adolescents and Adults Who Have Asthma That is Not Controlled by High Dose Inhaled Corticosteroid Asthma Medications

Summary

The primary objective of this study is to evaluate the dose response, efficacy and safety of 4 different doses of fluticasone propionate (50, 100, 200, and 400mcg) delivered as Fluticasone Spiromax® Inhalation Powder (Fp Spiromax) when administered twice daily in subjects 12 years of age and older with severe persistent asthma who are uncontrolled on high dose ICS therapy.

Timeline

Start

2012-04

Primary completion

2013-07

Completion

2013-10

Outcome

Missed primary endpoint

paper Numerical dose-related improvements in FEV1 were observed in all Fp MDPI groups over 12 weeks but were not significantly greater versus placebo. PMID 27937064 ↗

registry Fp MDPI 400 mcg vs Placebo MDPI; p = 0.0637; LSM difference 0.072 (95% CI -0.004 to 0.149) NCT01576718 ↗

Publications

• Bernstein DI, Gillespie M, Song S, Steinfeld J. Safety, efficacy, and dose response of fluticasone propionate delivered via the novel MDPI in patients with severe asthma: A randomized, controlled, dose-ranging study. J Asthma. 2017 Aug;54(6):559-569. doi: 10.1080/02770903.2016.1242137. Epub 2016 Oct 24.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Fluticasone propionate	Other / unclassified	50 ug	Inhaled
Subject	Fluticasone propionate	Other / unclassified	100 ug	Inhaled
Subject	Fluticasone propionate	Other / unclassified	200 ug	Inhaled
Subject	Fluticasone propionate	Other / unclassified	250 ug	Inhaled
Subject	Fluticasone propionate	Other / unclassified	400 ug	Inhaled
Background	Salbutamol	Unknown	90 ug	Inhaled

Indications