The Effect of Inhaled Fluticasone Propionate in the Treatment of Young Asthmatic Children

Bisgaard, Hans; Gillies, John; Groenewald, M.; Maden, Claire

doi:10.1164/ajrccm.160.1.9811024

Cited by 159 publications

(98 citation statements)

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“…Data from 2 clinical trials comparing inhaled corticosteroid treatment with placebo in young children show similar results to those reported in this study. 20,22 In the Bisgaard et al 20 study, the 12th week median change from baseline in percentage of symptom-free days was approximately 29% for fluticasone 100 g per day and approximately 21% for placebo. A similar analysis of our data shows generally comparable results, 30.6% symptom-free days for montelukast and 18.3% symptom-free days for placebo for weeks 11 and 12 combined.…”

Section: Discussionmentioning

confidence: 96%

Montelukast, a Leukotriene Receptor Antagonist, for the Treatment of Persistent Asthma in Children Aged 2 to 5 Years

et al. 2001

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ABSTRACT. Background. The greatest prevalence of asthma is in preschool children; however, the clinical utility of asthma therapy for this age group is limited by a narrow therapeutic index, long-term tolerability, and frequency and/or difficulty of administration. Inhaled corticosteroids and inhaled cromolyn are the most commonly prescribed controller therapies for young children with persistent asthma, although very young patients may have difficulty using inhalers, and dose delivery can be variable. Moreover, reduced compliance with inhaled therapy relative to orally administered therapy has been reported. One potential advantage of montelukast is the ease of administering a once-daily chewable tablet; additionally, no tachyphylaxis or change in the safety profile has been evidenced after up to 140 and 80 weeks of montelukast therapy in adults and pediatric patients aged 6 to 14 years, respectively.To our knowledge, this represents the first large, multicenter study to address the effects of a leukotriene receptor antagonist in children younger than 5 years of age with persistent asthma, as well as one of the few asthma studies that incorporated end points validated for use in preschool children.Objective. Our primary objective was to determine the safety profile of montelukast, an oral leukotriene receptor antagonist, in preschool children with persistent asthma. Secondarily, the effect of montelukast on exploratory measures of asthma control was also studied.Design and Statistical Analysis. We conducted a double-blind, multicenter, multinational study at 93 centers worldwide: including 56 in the United States, and 21 in countries in Africa, Australia, Europe, North America, and South America. In this study, we randomly assigned 689 patients (aged 2-5 years) to 12 weeks of treatment with placebo (228 patients) or 4 mg of montelukast as a chewable tablet (461 patients) after a 2-week placebo baseline period. Patients had a history of physician-diagnosed asthma requiring use of ␤-agonist and a predefined level of daytime asthma symptoms. Caregivers answered questions twice daily on a validated, asthmaspecific diary card and, at specified times during the study, completed a validated asthma-specific quality-oflife questionnaire. Physicians and caregivers completed a global evaluation of asthma control at the end of the study.Efficacy end points included: daytime and overnight asthma symptoms, daily use of ␤-agonist, days without asthma, frequency of asthma attacks, number of patients discontinued because of asthma, need for rescue medication, physician and caregiver global evaluations of change, asthma-specific caregiver quality of life, and peripheral blood eosinophil counts. Although exploratory, the efficacy end points were predefined and their analyses were written in a data analysis plan before study unblinding. At screening and at study completion, a complete physical examination was performed. Routine laboratory tests were drawn at screening and weeks 6 and 12, and submitted to a central laboratory for a...

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Section: Discussionmentioning

confidence: 96%

Montelukast, a Leukotriene Receptor Antagonist, for the Treatment of Persistent Asthma in Children Aged 2 to 5 Years

et al. 2001

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“…The treatment effect appears to be smaller than that seen in schoolage children and adults. For example, studies of ICSs in preschool children with multiple-trigger wheeze have reported a reduction in exacerbations by ,50% [107,108]. Compared to placebo, children using 200 mg?day -1 fluticasone exhibit a mean of 5% fewer days with symptoms [106].…”

Section: Inhaled Corticosteroidsmentioning

confidence: 99%

“…Dose-related effects have been shown for exacerbation rate on treatment with daily ICS doses of up to 400 mg?day -1 beclometasone equivalent (or 200 mg?day -1 fluticasone) via pressurised metered-dose inhaler (pMDI) with spacer (pMDI-S) [107], without any further benefit from higher doses. Comparison of 0.25, 0.5 and 1.0 mg nebulised budesonide daily, however, showed similar improvement to that with placebo in one study [109], whereas another suggested a dose relation in the range 0.25-1.0 mg nebulised budesonide b.i.d.…”

Section: Inhaled Corticosteroidsmentioning

confidence: 99%

Definition, assessment and treatment of wheezing disorders in preschool children: an evidence-based approach

Brand¹,

Baraldi²,

Bisgaard³

et al. 2008

European Respiratory Journal

746

759

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There is poor agreement on definitions of different phenotypes of preschool wheezing disorders. The present Task Force proposes to use the terms episodic (viral) wheeze to describe children who wheeze intermittently and are well between episodes, and multiple-trigger wheeze for children who wheeze both during and outside discrete episodes. Investigations are only needed when in doubt about the diagnosis.Based on the limited evidence available, inhaled short-acting b 2 -agonists by metered-dose inhaler/spacer combination are recommended for symptomatic relief. Educating parents regarding causative factors and treatment is useful. Exposure to tobacco smoke should be avoided; allergen avoidance may be considered when sensitisation has been established. Maintenance treatment with inhaled corticosteroids is recommended for multiple-trigger wheeze; benefits are often small. Montelukast is recommended for the treatment of episodic (viral) wheeze and can be started when symptoms of a viral cold develop.Given the large overlap in phenotypes, and the fact that patients can move from one phenotype to another, inhaled corticosteroids and montelukast may be considered on a trial basis in almost any preschool child with recurrent wheeze, but should be discontinued if there is no clear clinical benefit.Large well-designed randomised controlled trials with clear descriptions of patients are needed to improve the present recommendations on the treatment of these common syndromes.

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“…[1][2][3] A dose-dependent effect of FP 100 g and 200 g daily was demonstrated without defining the maximum effective dose. 4 Second, in our recent study on lung deposition of BUD in young children, we showed that lung dose from a fixed nominal dose of aerosol increases with age. 14 This suggests that, from a safety perspective, the prescribed dose of BUD inhaled from a pMDI with a NebuChamber spacer need not be adjusted for age.…”

Section: Discussionmentioning

confidence: 82%

“…Budesonide (BUD) and fluticasone propionate (FP) administered from pressurized metered-dose inhalers (pMDIs) and spacer devices have shown beneficial clinical improvements in 0-to 3-year-old children with asthma in randomized, controlled trials (RCTs) of health outcomes, [1][2][3][4] lung function and bronchial hyperreactivity, 5 and measurements of the inflammatory marker nitric oxide in exhaled air. 6 Therefore, the Global Initiative on Asthma International Guidelines recommend using ICS as controller treatment in young children with asthma with persistent symptoms.…”

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confidence: 99%

Systemic Activity of Inhaled Steroids in 1- to 3-Year-Old Children With Asthma

Anhøj

Bisgaard

2002

Pediatrics

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ABSTRACT. Objective. To study the systemic activity of inhaled steroids in young children.Methods. Forty children with mild asthma aged 1 to 3 years were studied in a 3-way crossover, randomized, placebo-controlled, double-blind trial. Treatment with inhaled fluticasone propionate, 200 g twice daily delivered via pressurized metered-dose inhaler (pMDI) and Babyhaler (FP400), was compared with budesonide, 200 g twice daily delivered via pMDI and NebuChamber (BUD400), and to placebo. The Babyhaler was primed before use. Knemometry was used to detect systemic steroid activity. It was performed with a handheld knemometer after 1 and 4 weeks of treatment. The increase in lower-leg length within this 3-week period was used as the outcome measure. The intention-to-treat population was analyzed by analysis of variance.Results. The increases in the lower-leg length during placebo, BUD400, and FP400 treatments were 85, 45, and 34 m/d, respectively (adjusted mean). The growth in lower-leg length was significantly reduced from both steroid treatments. The difference between BUD400 and placebo was ؊40 m/d (n ‫؍‬ 25; 95% confidence interval [CI]: ؊8 to ؊72). The difference between FP400 and placebo was ؊51 m/d (n ‫؍‬ 26; 95% CI: ؊19 to ؊83). The difference between FP and BUD was ؊11 m/d and was not statistically significant (n ‫؍‬ 28; 95% CI: 20 to ؊42).Conclusion. FP and BUD are both systemically active in children 1 to 3 years old when administered for 4 weeks from their dedicated spacer devices in daily doses of 400 g with no difference between the 2 steroid regimens. These findings call for studies of clinical side effects from these treatments of preschool children. Pediatrics 2002;109(3). URL: http://www.pediatrics.org/ cgi/content/full/109/3/e40; inhaled corticosteroid, young child, knemometry, side effects, systemic effects.ABBREVIATIONS. ICS, inhaled corticosteroids; BUD, budesonide; FP, fluticasone propionate; pMDI, pressurized metereddose inhaler; RCT, randomized, controlled trial; Plac, placebo. I nhaled corticosteroids (ICS) are effective treatments for asthma in young children. Budesonide (BUD) and fluticasone propionate (FP) administered from pressurized metered-dose inhalers (pMDIs) and spacer devices have shown beneficial clinical improvements in 0-to 3-year-old children with asthma in randomized, controlled trials (RCTs) of health outcomes, 1-4 lung function and bronchial hyperreactivity, 5 and measurements of the inflammatory marker nitric oxide in exhaled air. 6 Therefore, the Global Initiative on Asthma International Guidelines recommend using ICS as controller treatment in young children with asthma with persistent symptoms. 7 Side effects are of concern for any chronic drug therapy in pediatrics, especially ICS. 8 Recent reassuring data have suggested that long-term treatment of schoolchildren with inhaled BUD for an average of 9 years does not affect final height. 9 However, some aspects of the assessment of safety are unique to preschool children, including the rapid growth velocity and somewhat dif...

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The Effect of Inhaled Fluticasone Propionate in the Treatment of Young Asthmatic Children

Cited by 159 publications

References 13 publications

Montelukast, a Leukotriene Receptor Antagonist, for the Treatment of Persistent Asthma in Children Aged 2 to 5 Years

Montelukast, a Leukotriene Receptor Antagonist, for the Treatment of Persistent Asthma in Children Aged 2 to 5 Years

Definition, assessment and treatment of wheezing disorders in preschool children: an evidence-based approach

Systemic Activity of Inhaled Steroids in 1- to 3-Year-Old Children With Asthma

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