drugset / Trial / NCT00848965

A Randomised, Double Blind, Placebo Controlled, 4 Period, Incomplete Block, Crossover Study Assessing the Dose-response Curve of Fluticasone Propionate in an Antigen Challenge Chamber

NCT00848965 ↗

Phase 4 Completed 59 enrolled GlaxoSmithKline
RandomizedCrossoverTriple-blindTreatment

Summary

This is a single-centre, randomised, double-blind, four-period, incomplete block, crossover study, with 8 days repeat dosing of intranasal Fluticasone Propionate (25, 50, 100, 200ug) and/or placebo in the Vienna Challenge Chamber in subjects with allergic rhinitis.

Timeline

Start
2007-10
Primary completion
2008-01
Completion
2008-01

Outcome

Met primary endpoint

registry analysis (superiority or other test); Placebo vs 25 µg FP; Mean Difference (Final Values) -1.38 (95% CI -2.08 to -0.68) NCT00848965 ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject Fluticasone propionate Other / unclassified 25 ug Intranasal
Subject Fluticasone propionate Other / unclassified 50 ug Intranasal
Subject Fluticasone propionate Other / unclassified 100 ug Intranasal
Subject Fluticasone propionate Other / unclassified 200 ug Intranasal