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

Phase 4 Completed 474 enrolled GlaxoSmithKline

RandomizedParallel-groupQuadruple-blindTreatment

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.

Timeline

Start: 2007-11-26
Primary completion: 2011-03-01
Completion: 2011-03-17

Outcome

Missed primary endpoint

registry Mean Difference (Final Values) -0.270 (95% CI -0.48 to -0.06) NCT00570492 ↗

paper Once-daily treatment with FFNS over 52 weeks in prepubescent children resulted in a small reduction in growth velocity compared with placebo. PMID 25017530 ↗

Publications

Lee LA, Sterling R, Maspero J, Clements D, Ellsworth A, Pedersen S. Growth velocity reduced with once-daily fluticasone furoate nasal spray in prepubescent children with perennial allergic rhinitis. J Allergy Clin Immunol Pract. 2014 Jul-Aug;2(4):421-7. doi: 10.1016/j.jaip.2014.04.008. Epub 2014 May 21.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Fluticasone Furoate	Other / unclassified	110 ug	Intranasal