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| |  Inhaled Ciclesonide Improves Asthma Control: Presented at ACAAI By Micheal Casasnovas MIAMI BEACH, Fla -- November 19, 2009 -- Inhaled ciclesonide improved most asthma control endpoints in patients with mild to moderate asthma and its effectiveness was not affected whether the patient had a history of allergic rhinitis, according to a study presented here on November 8 at the American College of Allergy, Asthma & Immunology (ACAAI) annual scientific meeting. “Allergic rhinitis may worsen or complicate asthma treatment,” said Edward Kerwin, MD, Clinical Research Institute of Southern Oregon, Medford, Oregon. “This post hoc analysis assessed whether asthmatic subjects with a history of allergic rhinitis or without a history of allergic rhinitis responded differently to inhaled ciclesonide therapy as assayed by changes in FEV1 [forced expiratory volume in 1 second], nighttime awakenings, rescue albuterol use, and adverse events.” The 16-week, multinational, multicentre, randomised, double-blind, placebo-controlled, parallel-group study included patients aged at least 12 years (mean age, 36.7 years), experiencing mild to moderate asthma and not using inhaled corticosteroids for a month or more before screening. Patients were randomised to ciclesonide 80 mcg twice a day (n = 170), ciclesonide 160 mcg once a day (n = 173), ciclesonide 80 mcg twice a day for 4 weeks followed by ciclesonide 160 mcg once a day for 12 weeks (n = 171), or placebo (n = 177). Patients were determined to be positive for allergic rhinitis-positive (n = 472) or -negative (n = 219) using previous medical records. The researchers found improved mean FEV1 second from baseline to the average of week 12 and week 16 for allergic rhinitis-positive patients treated with ciclesonide 80 mcg twice a day, ciclesonide 160 mcg daily, ciclesonide 80 mcg twice a day for 4 weeks followed by ciclesonide 160 mcg daily for 12 weeks or placebo, and for allergic rhinitis-negative patients treated with ciclesonide 80 mcg twice a day and ciclesonide 160 mcg daily (all P < .02). FEV1 was found not to improve for allergic rhinitis-negative patients treated with ciclesonide 80 mcg twice a day for 4-weeks followed by ciclesonide 160 mcg daily for 12-weeks or placebo (P >= .19). Allergic rhinitis-positive and -negative patients had similar reductions in nighttime awakenings and rescue albuterol use (P values for difference between allergic rhinitis-positive and allergic rhinitis-negative >0.2) in all treatment groups. “The frequency of adverse events was similar across treatment groups and was not related to the presence or absence of allergic rhinitis,” said Dr. Kerwin. Allergic rhinitis-positive patients displayed improvement in FEV1 from baseline to the average week 12 and week 16 following all treatments (all P <= .014). Allergic rhinitis-negative patients displayed improvement in FEV1 from baseline to the average week 12 and week 16 following ciclesonide 80 mcg twice a day and ciclesonide 160-mcg daily therapy (all P < .004 versus baseline). “Only ciclesonide 80 mcg twice a day treatment improved flow expiratory volume greater than placebo [P = .0006],” said Dr. Kerwin. Researchers observed greater improvements in allergic rhinitis-positive patients than allergic rhinitis-negative patients following all treatments, and this was statistically significant following ciclesonide 80 mcg twice a day/ciclesonide 160 mcg daily therapy (P <= .05). All treatment groups decreased rescue albuterol use from baseline to week 16 (all P < .0001 versus baseline). Significant reduction in rescue albuterol use compared with placebo was noted in all ciclesonide treatments, besides the allergic rhinitis-positive ciclesonide 160 mcg daily treatment. Funding for this study was provided by sanofi-aventis, Nycomed GmbH, and Sepracor Inc. [Presentation title: An Examination of the Efficacy of Ciclesonide in Mild-to-Moderate Asthma Patients With and Without Co-Morbid Allergic Rhinitis. Abstract P95]
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