Ciclesonide in wheezy preschool children with a positive asthma predictive index or atopy

• Published in: Respiratory medicine Vol. 105; no. 11; pp. 1588 - 1595
• Main Authors: Brand, Paul L.P, Luz García-García, María, Morison, Adrian, Vermeulen, Jan H, Weber, Heinrich C
• Format: Journal Article
• Language: English
• Published: Kidlington Elsevier Ltd 01.11.2011; Elsevier; Elsevier Limited
• Subjects: Adrenal Cortex Hormones - therapeutic use; Asthma; Asthma - drug therapy; Asthma - physiopathology; Asthma predictive index; Atopy; Biological and medical sciences; Bronchodilator Agents - therapeutic use; Child; Child, Preschool; Children & youth; Chronic obstructive pulmonary disease, asthma; Ciclesonide; Clinical trials; Disease Progression; Dose-Response Relationship, Drug; Double-Blind Method; Drug therapy; Female; Forced Expiratory Volume - drug effects; Humans; Male; Medical sciences; Pneumology; Predictive Value of Tests; Pregnenediones - therapeutic use; Preschool children; Pulmonary/Respiratory; Respiratory Sounds - drug effects; Respiratory Sounds - physiopathology; Treatment Outcome; Germany; Netherlands; Preschool children; Ciclesonide; Asthma predictive index; Asthma; Atopy; Human; Allergy; Immunopathology; Lung disease; Respiratory disease; Bronchus disease; Obstructive pulmonary disease; Predictive factor; Child; Pneumology
• ISSN: 0954-6111; 1532-3064
• DOI: 10.1016/j.rmed.2011.07.017

Summary Background Few large-scale studies have examined inhaled corticosteroid treatment in preschool children with recurrent wheeze. We assessed the effects of ciclesonide in preschool children with recurrent wheeze. Methods We included children 2–6 yrs with recurrent wheeze and a positive asthma predictive index or aeroallergen sensitization to, excluding patients with episodic viral wheezing. After a 2–4-week baseline period, patients with ongoing symptoms or rescue medication use were randomised to once-daily ciclesonide 40, 80, 160 μg or placebo for 24 weeks. Results The number of wheeze exacerbations requiring systemic corticosteroids was unexpectedly low in all groups: 25 (10.2%) in placebo group, as compared to 11 (4.4%), 18 (7.3%), and 17 (6.7%) in ciclesonide 40, 80, and 160 μg, respectively. The difference in time to first exacerbation was not significantly different between groups ( p  = 0.786), but the difference in exacerbation rates between placebo and the pooled ciclesonide groups was ( p  = 0.03). Large and significant ( p  < 0.0001) improvements in symptom scores and rescue medication use occurred in all groups, including placebo. Improvements in FEV1 and FEF25–75 (measured in 284 4–6 yr olds) were larger in the ciclesonide than in the placebo group. No differences in safety parameters (adverse events, height growth, serum and urinary cortisol levels) between ciclesonide and placebo were observed. Conclusions In preschool children with recurrent wheeze and a positive asthma predictive index, ciclesonide modestly reduces wheeze exacerbation rates and improves lung function. A large placebo response and unexpected selection of patients with mild disease may have affected outcomes, highlighting the heterogeneity of preschool wheezing disorders.