NCT00570492

Phase 4 Fluticasone Furoate Nasal Spray (VERAMYST) Long Term Pediatric Growth Study.

A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multi-Center Study to Evaluate the Effects of a One-Year Course of Fluticasone Furoate Nasal Spray 110mcg QD on Growth in Pre-Pubescent, Pediatric Subjects With Perennial Allergic Rhinitis

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 474 (actual)
• Sponsor: GlaxoSmithKline · Industry
• Sex: All
• Age: 5 Years – 8 Years
• Healthy volunteers: Not accepted

Summary

The primary objective of this study is to characterize, as accurately as possible, the estimation of the difference in pre-pubescent growth velocities between subjects treated continuously for one year with FFNS 110mcg QD, the highest dose approved for pediatric use in the US, and placebo nasal spray as determined by stadiometry.

Conditions

• Rhinitis, Allergic, Perennial

Interventions

Type	Name	Description
DRUG	Fluticasone furoate nasal spray	Fluticasone furoate nasal spray 110mg QD
DRUG	Placebo nasal spray	Placebo nasal spray

Timeline

• Start date: 2007-11-26
• Primary completion: 2011-03-01
• Completion: 2011-03-17
• First posted: 2007-12-11
• Last updated: 2017-09-15
• Results posted: 2012-02-07

Locations

74 sites across 7 countries: United States, Argentina, Canada, Chile, France, Italy, Peru