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Alvesco Shows Comparable Relief of Asthma Symptoms to Budesonide, Fluticasone

March 22, 2005

Altana Pharma has reported data demonstrating that once-daily Alvesco, an inhaled corticosteroid for the treatment of asthma, is comparable to already-marketed, twice-daily inhaled corticosteroids, budesonide and fluticasone propionate.

In a 12-week study comparing Alvesco (ciclesonide) with fluticasone propionate, 697 patients aged 12 to 75, with persistent asthma, received either one inhalation of Alvesco 80 mcg or Alvesco 160 mcg in the evening, or inhalations of fluticasone propionate 88 mcg in both the morning and evening. Both once-daily Alvesco treatments were as effective as fluticasone 88 mcg twice-daily in improving FEV1, which was the primary measure for assessing efficacy. In addition, both treatments resulted in comparable improvements in asthma symptoms and use of rescue medication. The treatment was well-tolerated while the incidence of adverse events was comparable in all treatment groups.

In the second study, 404 adult patients with persistent asthma, who were receiving 400 mcg to 500 mcg per day of the inhaled corticosteroid beclomethasone dipropionate or equivalent doses from other products were switched to budesonide 200 mcg twice-daily for roughly two weeks. Following the baseline treatment, patients were randomized to receive either budesonide or once-daily inhalation of Alvesco for 12 weeks. All treatments maintained their lung function at the end of the baseline period with no significant change from baseline in FEV1 for any of the treatment groups, which was the primary measure for assessing efficacy. In all patients, asthma symptom scores and the use of rescue medication decreased or remained comparable to the baseline values during the 12-week treatment period. The treatment was well-tolerated, and the incidence of adverse events was comparable in all treatment groups.