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Efficacy and safety evaluation of ciclesonide in mild-to-moderate persistent asthma previously treated with inhaled corticosteroids

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Abstract:

Inhaled corticosteroids (ICSs) are recommended as first-line treatment for persistent asthma. This study was designed to evaluate the ability of ciclesonide (CIC) in subjects with stable asthma previously receiving another ICS or ICS/long-acting beta2-agonist (LABA) to maintain asthma disease control. In this 12-week, multicenter, double-blind, parallel-group study, subjects aged ≥12 years with stable mild-to-moderate persistent asthma were switched at randomization from an ICS or ICS/LABA to CIC, 80 g twice daily (CIC80 b.i.d.; n = 149); CIC, 160 g once daily (CIC160 q.d.; n = 150); or placebo (n = 147). Change in forced expiratory volume in 1 second (FEV1; primary end point), morning peak expiratory flow (PEF), rescue albuterol use, total asthma symptom score, nighttime awakenings, and safety were evaluated. FEV1 improved from baseline to week 12 after CIC80 b.i.d. treatment (+0.07 L; p = 0.0232), and was maintained after CIC160 q.d. (+0.01 L; p = 0.6217). FEV1 declined from baseline after placebo (−0.12 L; p < 0.0001) and significantly versus CIC treatments (p < 0.001). At week 12, morning PEF maintained baseline values after CIC80 b.i.d. (−4.43 L/minute; p = 0.1272) and decreased after CIC160 q.d. (−5.77 L/minute; p = 0.0490) and placebo (−12.82 L/minute; p < 0.0001); the difference between CIC80 b.i.d. and placebo was significant (p = 0.035). Baseline albuterol use, total daily asthma score, and nighttime awakenings were maintained after CIC treatments (p > 0.25), but increased after placebo (p ≤ 0.002); the difference between CIC80 b.i.d. and placebo was significant (p < 0.02). Incidence of adverse events was similar among treatment groups (range, 52.0‐57.9%). In this study, CIC80 b.i.d. maintained asthma control in subjects with stable mild-to-moderate asthma previously treated with ICS or ICS/LABA, was well tolerated, and, in general, was better than CIC160 q.d. in maintaining disease control.

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: http://dx.doi.org/10.2500/aap.2009.30.3241

Affiliations: Allergy and Asthma Medical Group and Research Center, San Diego, California, USA. eomeltzer@aol.com

Publication date: May 1, 2009

More about this publication?
  • 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.

    The goal of the Proceedings is to publish articles with a predominantly clinical focus which directly impact quality of care for patients with allergic disease and asthma.

    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.

    Articles marked "F" offer free full text for personal noncommercial use only.

    The journal is indexed in Thomson Reuters Web of Science and Science Citation Index Expanded, plus the National Library of Medicine's PubMed service.
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