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who tell me about dosage of approved ciclesonide

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[NILOUFAR]

HI, I HOPE YOU FIND THE FOLLOWING ARTICLE USEFUL,
BEST WISHES
NEL[:I]

ATS: Once-Daily Ciclesonide Treatment Improves Asthma Symptoms and Provides Superior Maintenance, Compared with Budesonide
By Bonnie Darves

SEATTLE, WA -- May 23, 2003 -- Ciclesonide, a new asthma drug, may be superior to budesonide in maintenance therapy for persistent asthma, according to a new study.

The results were presented here May 20th at the American Thoracic Society International Conference.

German researchers found that a once-daily evening dose of the inhaled glucocorticosteroids (ICS) significantly improved asthma symptom scores and morning pulmonary function, when compared with budesonide. "The clinical implication of this is that after 12 weeks of treatment and a regimen of 320 µg, ciclesonide increased lung function and reduced burdensome symptoms better than budesonide -- and there was no difference in adverse events between the two [drug] groups," said lead researcher Christoph Biberger, PhD.

In the randomized, double-blind, Phase III study, 198 patients received once-daily treatment with ciclesonide and 201 received a comparable (400 µg) dose of budesonide. All patients had a history of bronchial asthma for 6 months or longer, and had a baseline period of rescue medication only for 1 to 4 weeks before the start of the study. Both groups had a high number of ICS-naïve patients -- 59% in the ciclesonide group and 65% in the budesonide cohort -- and roughly two-thirds of both groups had moderate asthma severity.

Patients in both groups improved after 12 weeks of treatment, but the improvements were more pronounced in the ciclesonide group, Dr. Biberger said. Forced expiratory volume (FEV) increased by 411 mL in patients on ciclesonide, and 319 mL in those on budesonide. Use of rescue medications and overall symptom improvement was comparable for the 2 groups, but the improvement in morning peak expiratory flow (PEF) began occurring on day 3 with ciclesonide, versus week 2 with budenoside. "We saw a much earlier onset of effect with the ciclesonide," Dr. Biberger said.

In addition, forced vital capacity (FVC) increased significantly more in the ciclesonide group, to 467 mL, than in the budesonide group, whose FVC was 357 at end point. Adverse event frequency was similar for both the ciclesonide and budesonide groups, at 28% and 27%, respectively. Urine cortisol measurements were essentially unchanged from baseline to end point in both groups.

"It's also important -- and interesting -- to note that a high percentage of these patients were steroid-naive," Dr. Biberger said.

The study was funded by ALTANA Pharma AG.


[Study title: Efficacy and Safety of Ciclesonide Compared with Budesonide in Asthma Patients: A Randomized 12-week Study. Poster D62]