Effects of inhaled fluticasone propionate in children less than 2 years old with recurrent wheezing

Abstract

Our objective was to evaluate the efficacy and safety of two doses of fluticasone propionate (FP) in young children with recurrent wheezing and risk factors for asthma. Our study design was a randomized, double-blind, placebo-controlled comparison of inhaled FP 50 mcg twice daily (FP 100) and 125 mcg twice daily (FP 250), for 6 months. Outcome measures included number of wheezing episodes, days on albuterol, height standard deviation score (height SDS), osteocalcin (OC), bone alkaline phosphatase fraction (AKP), insulin-like growth factor-binding protein 3 (IGFBP-3), and serum levels of cortisol (SC). Our subjects were 30 patients, aged 7-24 months. Mean wheezing episodes were 6.0 +/- 1.9, 1.9 +/- 1.9, and 2.8 +/- 1.2; mean days of albuterol use were 24.3 +/- 1.3, 6.5 +/- 0.8, and 9.1 +/- 0.8, per patient for placebo, FP100, and FP250 groups, respectively. There was a significant reduction in clinical outcome in the two FP groups compared to placebo (P < 0.01). No significant correlations were found between FP dosage and height SDS, OC, AKP, IGFBP-3, and SC. In conclusion, in young children with asthmatic symptoms, FP at 50 and 125 mcg b.i.d. for 6 months significantly improved respiratory symptoms without causing significant side effects on growth and bone metabolism.

Global strategy for the diagnosis and management of asthma in children 5 years and younger

“…However, the available data in children 5 years and younger suggest that, as in older children, clinically effective doses of inhaled glucocorticosteroids are safe and the potential risks are well balanced by the clinical benefits 56,62,72 . Generally, low doses of inhaled glucocorticosteroids ( .…”

Efficacy and safety of fluticasone propionate hydrofluoroalkane inhalation aerosol in pre–school-age children with asthma: A randomized, double-blind, placebo-controlled study

“…[5][6][7][8] The current study was not designed to compare FP HFA with the CFC formulation in this patient population. However, previous studies have shown that the HFA and CFC formulations are therapeutically comparable at equal doses in both school-age children 4 and adolescent and adult patients with asthma.…”

“…A 2-way crossover study in 13 patients age 4 to 11 years with asthma found that FP systemic exposure after 7 days of twice-daily dosing with 88 g twice daily was 55% lower with FP HFA compared with FP CFC. 3 Although the efficacy and safety of FP CFC in pre-school-age children (ie, age 1 to Ͻ 4 years) with asthma has been evaluated previously, [5][6][7][8] only limited data are available regarding the safety and efficacy of the HFA formulation in children age Ͻ 4 years. Many children underϾ age 4 years are less able to benefit from the currently approved inhaled corticosteroids (ICS) due to the complexity of administering some nebulized and breath-actuated inhalation powder devices, the latter requiring generation of sufficient inspiratory flow.…”

Chambres d’inhalation pour délivrance de fluticasone chez le nourrisson au banc d’essai

“…Les études cliniques, chez les enfants de moins de un an déclarés asthmatiques, avec la fluticasone administrée par chambre d'inhalation, sont très peu nombreuses et incluent généralement peu de patients [2][3][4][5][6]. Les symptômes d'asthme sont souvent améliorés mais les fonctions respiratoires, évaluées par compression thoracique avec mesure du débit maximal à la capacité résiduelle fonctionnelle (CRF), le sont de façon plus variable (effet positif [4,6] ou semblable au placebo [5]).…”