Original articleEfficacy and safety of fluticasone propionate hydrofluoroalkane inhalation aerosol in pre–school-age children with asthma: A randomized, double-blind, placebo-controlled study
Section snippets
Patients
This study evaluated children age 1 to < 4 years with a history of symptomatic asthma who had experienced 2 or more episodes of increased asthma symptoms requiring medical attention and asthma treatment within the year before screening. During the 4 weeks before screening, the children must have reported treatment with a short-acting beta-agonist for relief of respiratory symptoms 3 or more times per week.
Exclusion criteria included the following: before screening, low-dose ICS or intranasal
Patients
Of the 572 children screened, 359 (239 in the FP HFA group and 120 in the placebo HFA group) were randomized to treatment. Stratification by age was achieved, with 31% of the placebo HFA group and 30% of the FP HFA group age 1 to < 2 years at randomization. The most common reason for not being randomized was failure to meet the average weekly asthma symptom score (≥ 1.1) criterion. Demographic and baseline clinical characteristics were similar in the 2 treatment groups (Table I). Mean baseline
Discussion
National and international asthma management guidelines recommend that children with mild, moderate, or severe persistent asthma be preferentially treated with a regimen that includes an ICS.11, 12, 13 In children age 1 to < 4 years, FP HFA 88 μg twice daily was significantly more effective than placebo at improving 24-hour daily and nighttime asthma symptom scores.
At endpoint, the mean percent reduction in 24-hour daily asthma symptom scores was approximately 10% greater in the FP HFA group
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Pediatrics
Flovent® (fluticasone propionate) inhalation aerosol prescribing information [package insert]
Fluticasone propionate 100 μg bid using a non-CFC propellant, HFA 134a, in asthmatic children
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The effect of inhaled fluticasone propionate in the treatment of young asthmatic children: a dose comparison study
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2012, Journal of Allergy and Clinical ImmunologyCitation Excerpt :Over the past decade, it has become evident that daily therapy with ICSs is effective in improving asthma control in the preschool-aged asthmatic population. Multiple trials have demonstrated the efficacy of several ICS preparations, including budesonide inhalation suspension,49-51 fluticasone propionate metered-dose inhaler (MDI),24,52-56 and ciclesonide MDI.57 A recent systematic literature review58 and meta-analysis41 both concluded that maintenance therapy with ICSs is more effective than placebo in controlling asthma symptoms in preschool children, with the effect on exacerbations most evident among children with a clinical diagnosis of asthma rather than recurrent wheezing not diagnosed as asthma.41
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2010, Journal of Allergy and Clinical ImmunologyEfficacy and safety of ciclesonide once daily and fluticasone propionate twice daily in children with asthma
2009, Pulmonary Pharmacology and TherapeuticsCitation Excerpt :However, as the MCh challenge was only performed at a subgroup of sites, the study may not have been sufficiently powered for this variable. A placebo arm might have facilitated the interpretation of this result; however, this was not included because low doses of both ciclesonide and fluticasone propionate have previously been demonstrated to be clinically more effective than placebo in controlling asthma and improving lung function in patients with persistent asthma [8,26,27]. Furthermore, 12 weeks of treatment with placebo in patients with moderate and severe asthma would have been deemed unacceptable by many ethics committees and could have caused excessive dropouts.
Drugs acting on the respiratory tract
2009, Side Effects of Drugs AnnualCitation Excerpt :In a double-blind, randomized, placebo-controlled study in 332 asthmatic children aged 24–47 months, fluticasone propionate 44 or 88 μg bd for 12 weeks had no effect on growth velocity or 12-hour overnight urinary cortisol excretion (16C). There were similar results in 359 asthmatic children aged 1–4 years randomized to fluticasone propionate 88 μg bd or placebo for 12 weeks (23C). In 24 asthmatic children randomized to beclomethasone dipropionate 100 μg bd or budesonide 100 or 200 μg bd in a double-blind crossover study, lower leg growth rate over 3 months did not differ between the groups (24c).
Recurrent wheezing in three year-olds: Facts and opportunities
2008, Anales de Pediatria
Supported by a grant from GlaxoSmithKline. Drs. Qaqundah, Sugerman, Ceruti, and Maspero are Investigators for GlaxoSmithKline; Mr. Kleha, Ms. Scott, and Drs. Wu, Mehta, and Crim are employees of GlaxoSmithKline.