Ciclesonide reduces the need for oral steroid use in adult patients with severe, persistent asthma.

Full Abstract

STUDY

OBJECTIVES:
Oral corticosteroids (OCS) may be associated with systemic adverse events (AEs), which can be reduced by replacing OCS with inhaled corticosteroids (ICS). The potential of ciclesonide, a novel ICS, to reduce OCS use in patients with severe, persistent asthma was evaluated in this study.

DESIGN:
A phase III, 12-week, international, multicenter, double-blind, placebo-controlled, parallel-group study.

PATIENTS:
Adult and adolescent patients (> or = 12 years old; n = 141) with severe, persistent, oral steroid (prednisone)-dependent asthma.

INTERVENTIONS:
Patients were randomized to receive ciclesonide (640 mug/d or 1,280 microg/d [ex-actuator]) bid or placebo for 12 weeks. Weekly evaluations determined eligibility for prednisone dose reduction based on predetermined criteria.

MEASUREMENTS AND RESULTS:
The prednisone dose was significantly reduced by 47% and 63% in the groups receiving ciclesonide, 640 microg/d, and ciclesonide, 1,280 microg/d, respectively, vs an increase of 4% in the placebo group (both p < or = 0.0003) at week 12. By week 12, prednisone was discontinued by approximately 30% of patients in the ciclesonide-treated groups, vs 11% of patients in the placebo group (both p < or = 0.04). FEV1 improved significantly at week 12 in the ciclesonide treatment groups vs placebo (p < 0.03). The occurrence of local and systemic AEs was comparable between all treatment groups.

CONCLUSION:
Study results suggest that ciclesonide significantly reduces the need for OCS in patients with severe, persistent asthma, while maintaining asthma control.

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Author information

Author/s: Bateman, Eric (E); Karpel, Jill (J); Casale, Thomas (T); Wenzel, Sally (S); Banerji, Donald (D);

Affiliation: University of Cape Town Lung Institute, PO Box 34560, Groote Schuur 7937, Cape Town, South Africa. ebateman(-atsign-)uctgsh1.uct.ac.za

Journal and publication information

Publication Type: Clinical Trial, Phase III; Journal Article; Multicenter Study; Randomized Controlled Trial; Research Support, Non-U.S. Gov't

Journal: Chest (Chest), published in United States. (Language: eng)

Reference: 2006-May; vol 129 (issue 5) : pp 1176-87

Dates: Created 2006/05/10; Completed 2006/05/30; Revised 2006/11/15;

PMID: 16685007, status: MEDLINE (last retrieval date: 12/26/2008)

Sourced from the National Library of Medicine. Abstract text and other information may be subject to copyright.

Comments and Corrections

CommentIn: Chest. 2006 May;129(5):1124-5. (PMID: 16685000)

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MeSH headings (categories)

This article was linked to the MESH Headings shown below.

Administration, Oral
Adolescent
Adult
Aged
Asthma - drug therapy; physiopathology
Child
Dose-Response Relationship, Drug
Double-Blind Method
Drug Interactions
Female

Follow-Up Studies
Forced Expiratory Volume
Glucocorticoids - administration & dosage; therapeutic use
Humans
Male
Middle Aged
Prednisone - administration & dosage; therapeutic use
Pregnenediones - therapeutic use
Severity of Illness Index
Treatment Outcome

Associated Chemicals: Glucocorticoids (0) ; Pregnenediones (0) ; ciclesonide (141845-82-1) ; Prednisone (53-03-2)

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