Authors: Berger, William E.¹; Kerwin, Edward; Bernstein, David I.; Pedinoff, Andrew; Bensch, George; Karafilidis, John

Source: Allergy and Asthma Proceedings, Volume 30, Number 3, May-June 2009 , pp. 304-314(11)

Publisher: OceanSide Publications, Inc

Abstract:

Inhaled corticosteroids (ICSs) are a first-line treatment for persistent asthma. This study was designed to compare the efficacy and safety of ciclesonide (CIC) in subjects with mild-to-moderate persistent asthma not using an ICS. This was a multicenter, double-blind, parallel-group, placebo-controlled, 16-week study in subjects who were ≥12 years old, had a ≥6-month history of persistent asthma, a forced expiratory volume in 1 second (FEV₁) of ≥60 to ≤85% predicted, and who were not using an ICS ≤30 days before study entry. Subjects were randomized to CIC, 80 μg twice daily (CIC80 b.i.d.; n = 170); CIC, 160 μg once daily in the morning (CIC160 q.d. in the A.M.; n = 173); CIC80 b.i.d. for 4 weeks followed by CIC160 q.d. for 12 weeks (CIC80 b.i.d./CIC160 q.d.; n = 171); or placebo (n = 177). Change in FEV₁ from baseline to the average of weeks 12 and 16 (primary end point) and to week 16, A.M. peak expiratory flow, rescue albuterol use, nighttime awakenings, asthma symptom scores, and safety were evaluated. FEV₁ improved from baseline to the average of weeks 12 and 16 for CIC80 b.i.d. (+0.30L; p < 0.0001), CIC160q.d. (+0.19L; p < 0.0001), CIC80 b.i.d./CIC160 q.d. (+0.19L; p < 0.0001), and placebo (+0.06L; p = 0.0251); improvement was greatest for CIC80 b.i.d. (p < 0.01). At week 16, all CIC treatments significantly improved FEV₁ and A.M. PEF from baseline (p < 0.0001) and compared with placebo (p ≤ 0.015). All treatments reduced albuterol use and nighttime awakenings and improved asthma symptom scores (p ≤ 0.05 versus baseline); these improvements were greater for CIC80 b.i.d. than for placebo (p < 0.01). The incidence of adverse events was similar among treatment groups (range, 53-58%). In this study, CIC80 b.i.d. improved disease control in subjects with mild-to-moderate persistent asthma not using an ICS and provided greater improvements than CIC160 q.d.

Keywords: Asthma; ciclesonide; controller medication; inhaled corticosteroids; maintenance therapy; mild-to-moderate asthma; pulmonary function; randomized controlled trial; rescue medication; safety

Document Type: Research article

DOI: 10.2500/aap.2009.30.3242

Affiliations: 1: Allergy and Asthma Associates of Southern California, Mission Viejo, California, USA. wberger@uci.edu

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• Allergy and Asthma Proceedings is a peer reviewed publication dedicated to distributing timely scientific research regarding advancements in the knowledge and practice of allergy, asthma and immunology. Its primary readership consists of allergists and pulmonologists.
  
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  Featured topics include asthma, rhinitis, sinusitis, food allergies, allergic skin diseases, diagnostic techniques, allergens, and treatment modalities. Published material includes peer-reviewed original research, clinical trials and review articles.
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