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J Allergy Clin Immunol Pract. 2014 Jul-Aug;2(4):421-7. doi: 10.1016/j.jaip.2014.04.008. Epub 2014 May 21.

Growth velocity reduced with once-daily fluticasone furoate nasal spray in prepubescent children with perennial allergic rhinitis.

Author information

1
Respiratory Research and Development, GlaxoSmithKline, Research Triangle Park, NC. Electronic address: laurie.a.lee@gsk.com.
2
Department of Otolaryngology Carolina Research, Orangeburg, SC.
3
Allergy and Respiratory Research Unit, Fundacion CIDEA, Buenos Aires, Argentina.
4
Respiratory Research and Development, GlaxoSmithKline, Research Triangle Park, NC.
5
Pediatric Research Unit, Kolding Hospital, Kolding, Denmark.

Abstract

BACKGROUND:

The effect of fluticasone furoate nasal spray (FFNS) on growth in prepubescent children has not been evaluated.

OBJECTIVE:

To characterize the difference in mean prepubescent growth velocities, as determined by stadiometry, between patients treated continuously for 1 year with FFNS 110 mcg once daily and placebo nasal spray.

METHODS:

This was a multicenter, randomized, double-blind, placebo-controlled, parallel-group 76-week safety study. Nasal symptom assessments were used as a measure of adherence. Eligible patients were ages 5 to <8.5 years at screening and had at least a 1-year clinical history and diagnosis of perennial allergic rhinitis, including a positive skin test or specific IgE to an appropriate perennial allergen within the past year.

RESULTS:

One hundred eighty-six patients in the FFNS group and 187 patients in the placebo group completed the entire 52-week treatment period. During treatment, the least squares mean growth velocity was 5.19 cm/y for the FFNS group and 5.46 cm/y for the placebo group; mean difference, -0.270 cm/y (95% CI, -0.48 to -0.06 cm/y). Other safety assessments, including 24-hour urinary cortisol excretion, were comparable between the treatment groups. Daily reflective total nasal symptom scores declined similarly in both the FFNS and placebo groups.

CONCLUSION:

Once-daily treatment with FFNS over 52 weeks in prepubescent children resulted in a small reduction in growth velocity compared with placebo. Clinicians will need to balance the reduction in growth observed with FFNS to its potential for clinical benefit.

TRIAL REGISTRATION:

ClinicalTrials.gov NCT00570492.

KEYWORDS:

24-Hour urinary cortisol; Children; Intranasal corticosteroid; Placebo controlled; Randomized clinical trial; Stadiometry

PMID:
25017530
DOI:
10.1016/j.jaip.2014.04.008
[Indexed for MEDLINE]

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