Chest
Original Research: AsthmaCiclesonide Reduces the Need for Oral Steroid Use in Adult Patients With Severe, Persistent Asthma
Section snippets
Methods and Materials
Male and female patients aged ≥ 12 years with OCS-dependent, severe, persistent asthma (according to the Global Initiative for Asthma guidelines35) diagnosed at least 12 months prior to screening were enrolled in a 12-week, international, randomized, double-blind, placebo-controlled, parallel-group study. Patients were required to have received oral prednisone daily or on alternate days for at least 5 of the previous 6 months (5 to 30 mg/d and/or 10 to 60 mg every other day) and to have
Patient Characteristics
The trial was conducted between July 2001 and March 2003. Overall, 241 patients were screened, and 141 patients (80 in the United States and 61 in South Africa) were randomized to receive treatment at 60 sites within these countries (CIC640, n = 47; CIC1280, n = 49; placebo, n = 45). Patient disposition throughout the clinical trial is shown in Figure 1. The ITT population consisted of 140 patients; 1 patient in the CIC1280 group was excluded due to not having postbaseline measurements. All 141
Discussion
This study was designed to assess the OCS-sparing potential of ciclesonide in adult and adolescent patients with OCS-dependent, severe, persistent asthma. The results suggested that the substitution of twice-daily inhaled ciclesonide for high doses of other forms of ICS significantly reduced the dose of prednisone required by these patients. Although no significant dose-response effect was noted between the 640 μg/d and 1,280 μg/d dosages, the higher dose demonstrated a greater numeric trend
Conclusion
In conclusion, the results of this study suggest that twice-daily treatment with inhaled ciclesonide (640 μg/d or 1,280 μg/d) is a well-tolerated method for reducing (and potentially discontinuing) OCS use in patients with severe, persistent asthma, thus minimizing the risk of the AEs associated with OCS use.
ACKNOWLEDGMENT
We thank the following investigators for their participation in the study: Abdool-Gaffar, Mohamed; Abdullah, Ismail; Albery, Richard; Algatt-Bergstrom, Pamela; Bailey, William; Baz, Malik; Bernstein, David; Busse, William; Butterfield, Joseph; Caldwell, Jacques; Calhoun, William; Chipps, Bradley; Colice, Gene; Condemi, John; Conway, Michael; Cook, David; Craig, Timothy; Daffern, Pamela; D'Alonzo, Gilbert; Duvenhage, Cornelia; Fidelholtz, James; Fink, Jordan; Fino, Gregory; Foden, Alwyn; Fox,
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2022, Clinical Microbiology and InfectionCitation Excerpt :One of the treatments studied was inhaled ciclesonide. Ciclesonide has a favourable safety profile and anti-inflammatory properties for the respiratory tract [10]. The onset of action is faster with ciclesonide than with budesonide for improving lung function in asthmatic patients [11].
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2018, Advanced Drug Delivery ReviewsCitation Excerpt :Ciclesonide by contrast is a pro-drug that becomes active on reaching the site of action in the lung [91, 92]. Ciclesonide 640 μg and 1280 μg twice daily for 12 weeks reduced the need for oral cortico-steroids in those with severe and persistent asthma with discontinuation of prednisone at 12 weeks in 30% of patients on ciclesonide versus 11% on placebo [93]. Ciclesonide 320 μg four times daily was shown to have similar efficacy to budesonide 800 μg four times daily in adolescents with severe asthma [94].
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Reproduction of this article is prohibited without written permission from the American College of Chest Physicians (www.chestjournal.org/misc/reprints.shtml).
This study was funded by sanofi-aventis U.S. Inc., a member of the sanofi-aventis Group, and ALTANA Pharma AG.
Dr. Bateman has served as a consultant and is a member of an advisory board for Aventis Pharma. Dr. Karpel is a member of an advisory board for ALTANA and Schering-Plough; is on the Speaker's Bureau for Boehringer-Ingelheim, Genentech, Glaxo, Novartis, Pfizer, and Schering-Plough; and has received grants from AstraZeneca, ALTANA, Boehringer-Ingelheim, Dey, and Genentech. Dr. Casale has served as a consultant for Allux, Aperon, Aventis, Corixa, Genentech, Merck, Novartis, and Sugitomo; is a member of a Data Monitoring Board for Hoffman-LaRoche; is on a Speaker's Bureau and has given talks sponsored by Aventis, Genentech, Novartis, and Merck; and is an investigator for contract research performed through Creighton University for Capnia, Corixa, Dynavax, IDEC, MediciNova, Merck, NIAID/ITN, Novartis, Ono, and Pfizer. Dr. Wenzel has received grants from and has served as a consultant and is a member of an advisory board for ALTANA and sanofi-aventis. Dr. Banerji is an employee of sanofi-aventis and holds stock options in the company.
This was an international study conducted in the United States and South Africa.
Data from this study have been previously reported in the form of an abstract to the American Thoracic Society International Congress, San Diego, CA 2005.