Longitudinal growth in infants and young children treated with budesonide inhalation suspension for persistent asthma☆,☆☆,★
Section snippets
Subjects
Boys and girls (aged 6 months to 8 years) with persistent asthma from 3 multicenter, randomized, 12-week, double-blind, placebo-controlled studies were eligible to enroll in three 52-week open-label extension studies. Details of the inclusion/exclusion criteria and findings for the 12-week studies are reported elsewhere.2, 16, 17 In general, subjects were included in each of the 52-week extension studies if they completed one of the 12-week, double-blind studies or were discontinued from
Subjects
In total, 670 subjects were evaluable in the 52-week studies; of these, 223 subjects received CAT and 447 received BIS. Subject demographics and baseline asthma characteristics for each of the studies are shown in Tables I and II, respectively. Overall and within each study, sex and race distributions were comparable between the CAT and BIS groups (Table I). Children in study B were older (aged 4 to 9 years) and hence taller than children in studies A (aged 8 months to 9 years) and C (aged 1
DISCUSSION
The effects of inhaled GCSs on growth in children have been at the forefront of pediatric asthma treatment issues since the US Food and Drug Administration (FDA) convened a joint meeting of the Pulmonary Allergy and the Metabolic Endocrinologic Drug Advisory Committees in July 1998. In the current study the effects of BIS on growth were assessed in 3 different populations of children with asthma who therefore had different treatment needs: study A included children with mild persistent asthma
Acknowledgements
We thank Betty Angelini, RN, BSN, and Nancy Bormann, PhD, for their thoughtful review of this manuscript.
References (43)
- et al.
Budesonide treatment of moderate and severe asthma in children: a dose-response study
J Allergy Clin Immunol
(1995) - et al.
Efficacy and safety of budesonide inhalation suspension (Pulmicort Respules) in young children with inhaled steroid-dependent, persistent asthma
J Allergy Clin Immunol
(1998) - et al.
Effects of long-term treatment with an inhaled corticosteroid on growth and pulmonary function in asthmatic children
Respir Med
(1994) - et al.
Effect of early vs late intervention with inhaled corticosteroids in asthma
Chest
(1995) - et al.
Once-daily budesonide inhalation suspension for the treatment of persistent asthma in infants and young children
Ann Allergy Asthma Immunol
(1999) - et al.
Maturational delay and temporal growth retardation in asthmatic boys
J Allergy Clin Immunol
(1977) - et al.
Growth and adrenal suppression in asthmatic children treated with high-dose fluticasone propionate
Lancet
(1996) - et al.
Growth in asthmatic children treated with fluticasone propionate
J Pediatr
(1998) - et al.
A comparative study of the effects of inhaled corticosteroid, budesonide, and a beta 2-agonist, terbutaline, on airway inflammation in newly diagnosed asthma: a randomized, double-blind, parallel-group controlled trial
J Allergy Clin Immunol
(1992) - et al.
Effects of 22 months of treatment with inhaled corticosteroids and/or beta-2-agonists on lung function, airway responsiveness, and symptoms in children with asthma
Am Rev Respir Dis
(1992)
Clinical efficacy of low-dose inhaled budesonide once or twice daily in children with mild asthma not previously treated with steroids
Eur Respir J
Effects of reducing or discontinuing inhaled budesonide in patients with mild asthma
N Engl J Med
Childhood Asthma Management Program Research Group. Relationships between duration of asthma and asthma severity among children in the Childhood Asthma Management Program (CAMP)
J Allergy Clin Immunol
National Asthma Education Program Expert Panel report: guidelines for the diagnosis and management of asthma
A comparison of the efficacy and safety of inhaled corticosteroids in asthma
Allergy
Inhaled corticosteroids and growth in children
Pediatr Ann
Growth of prepubertal children with mild asthma treated with inhaled beclomethasone dipropionate
Am J Respir Crit Care Med
A comparison of beclomethasone, salmeterol, and placebo in children with asthma
N Engl J Med
Aerosol beclomethasone dipropionate compared with theophylline as primary treatment of chronic, mild to moderately severe asthma in children
Pediatrics
One year treatment with salmeterol compared with beclomethasone in children with asthma
Am J Respir Crit Care Med
A multiple-dosing, placebo-controlled study of budesonide nebulizing suspension given once or twice daily for treatment of persistent asthma in young children and infants
Pediatrics
Cited by (0)
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Supported by AstraZeneca LP.
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Reprint requests: David P. Skoner, MD, Division of Allergy, Immunology, and Infectious Diseases, Children’s Hospital of Pittsburgh, Department of Pediatrics, 3705 Fifth Ave at DeSoto, Pittsburgh, PA 15213-2583.
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0091-6749/2000 $12.00 + 0 1/1/103823