drugset / Trial / NCT01687283

Efficacy and Safety Study of Fluticasone Proponate Inhalation Solution in Adult and Adolescent Asthma

NCT01687283

Phase 3 Completed 316 enrolled GlaxoSmithKline
RandomizedParallel-groupSingle-blindTreatment

Summary

This is a multicentre, randomized, single-blind, active-controlled, parallel-group phase III local registration study for a treatment period of 12 weeks. This study aims to assess the effectiveness and safety of fluticasone propionate 1mg via nebulizer BID in treatment of Chinese adult and adolescent patients with severe persistent asthma for a treatment period of 12 weeks versus budesonide 2mg via nebulizer BID. The steady-state plasma pharmacokinetics of fluticasone propionate inhalation solution will also be assessed.

Timeline

Start
2012-09-27
Primary completion
2013-11-07
Completion
2013-11-07

Drugs

EvaluationDrugModalityDoseRoute
Comparator Budesonide Small molecule 2 mg Other
Subject Fluticasone propionate Other / unclassified 1 mg Other

Indications