At a glance
ClinicalIndex Comparison RecordPhase 4Completed· 474 enrolled
Drug / intervention
Fluticasone furoate nasal spray +1 moredrug
Likely dose
Fluticasone furoate nasal spray 110mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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
In Brief
A Phase 4 clinical trial evaluating Fluticasone furoate nasal spray and Placebo nasal spray for Rhinitis, Allergic, Perennial. Completed, enrolled 474 participants across 74 sites in 7 countries.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsRhinitis, Allergic, Perennial
CountriesArgentina, Canada, Chile, France, Italy, Peru, United States
Collaborators--
Timeline
Phase 4CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartNov 2007
First PostedDec 2007
Primary CompletionMar 2011
Study CompletionMar 2011
TodayJul 2026
First PostedDec 11, 2007
Enrollment StartNov 26, 2007
Primary CompletionMar 1, 2011
Study CompletionMar 17, 2011
TodayJul 2, 2026
Enrollment to primary: 3.3 yearsPosted 18.6 years ago
Interventions
Fluticasone furoate nasal spraydrug
Fluticasone furoate nasal spray 110mg QD
Placebo nasal spraydrug
Placebo nasal spray