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Therapeutic Research
- Authors: Mitsuru Adachi1, et al
Abstract
Objective and background:Inhaled corticosteroid(ICS)is recommended as a first−line therapy for the management of asthma, but its long−term use may be limited by concerns about adverse reactions. Ciclesonide, a novel pro−drug ICS demonstrates anti−inflammatory action after activation in the lungs and it is expected to have less adverse reactions. The objective of this study was to evaluate the safety and efficacy of ciclesonide in long−term administration to adult patients with bronchial asthma. Methodology:During the 2−week baseline period, the patient received the same treatments as before the study. In the first 4 weeks of the treatment period, 143 patients received ciclesonide 800μg and thereafter, 200, 400 or 800μg depending on their symptoms for 24 or 48 weeks. Safety was assessed by adverse events, laboratory tests, vital signs, and the corticotropin−releasing hormone(CRH)stimulation test, and efficacy was assessed by peak expiratory flow(PEF), spirometric measurements and asthmatic score. Results:For adverse events, laboratory tests and vital signs, there were no clinically important findings. The CRH stimulation test revealed no suppression to the hypothalamicpituitary−adrenal axis. From week 2, morning PEF increased significantly compared to the baseline period and the increase was maintained throughout the 52 week treatment period. Other measurements of efficacy were either improved or maintained during the treatment period. The quality of life(QOL)assessment showed significant improvement in the scoreson nearly all scales.Conclusions:In the long−term treatment of bronchial asthma in adult patients,ciclesonide was safe, well−tolerated and efficacious. Ciclesonide also improved the QOL.
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