PMID- 16685007
OWN - NLM
STAT- MEDLINE
DCOM- 20060530
LR  - 20131121
IS  - 0012-3692 (Print)
IS  - 0012-3692 (Linking)
VI  - 129
IP  - 5
DP  - 2006 May
TI  - Ciclesonide reduces the need for oral steroid use in adult patients with severe, 
      persistent asthma.
PG  - 1176-87
AB  - 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.
FAU - Bateman, Eric
AU  - Bateman E
AD  - University of Cape Town Lung Institute, PO Box 34560, Groote Schuur 7937, Cape 
      Town, South Africa. ebateman@uctgsh1.uct.ac.za
FAU - Karpel, Jill
AU  - Karpel J
FAU - Casale, Thomas
AU  - Casale T
FAU - Wenzel, Sally
AU  - Wenzel S
FAU - Banerji, Donald
AU  - Banerji D
LA  - eng
PT  - Clinical Trial, Phase III
PT  - Journal Article
PT  - Multicenter Study
PT  - Randomized Controlled Trial
PT  - Research Support, Non-U.S. Gov't
PL  - United States
TA  - Chest
JT  - Chest
JID - 0231335
RN  - 0 (Glucocorticoids)
RN  - 0 (Pregnenediones)
RN  - S59502J185 (ciclesonide)
RN  - VB0R961HZT (Prednisone)
SB  - IM
CIN - Chest. 2006 May;129(5):1124-5. PMID: 16685000
MH  - Administration, Oral
MH  - Adolescent
MH  - Adult
MH  - Aged
MH  - Asthma/*drug therapy/physiopathology
MH  - Child
MH  - Dose-Response Relationship, Drug
MH  - Double-Blind Method
MH  - Drug Interactions
MH  - Female
MH  - Follow-Up Studies
MH  - Forced Expiratory Volume
MH  - Glucocorticoids/*administration & dosage/therapeutic use
MH  - Humans
MH  - Male
MH  - Middle Aged
MH  - Prednisone/*administration & dosage/therapeutic use
MH  - Pregnenediones/*therapeutic use
MH  - Severity of Illness Index
MH  - Treatment Outcome
EDAT- 2006/05/11 09:00
MHDA- 2006/05/31 09:00
CRDT- 2006/05/11 09:00
PHST- 2006/05/11 09:00 [pubmed]
PHST- 2006/05/31 09:00 [medline]
PHST- 2006/05/11 09:00 [entrez]
AID - S0012-3692(15)50695-8 [pii]
AID - 10.1378/chest.129.5.1176 [doi]
PST - ppublish
SO  - Chest. 2006 May;129(5):1176-87. doi: 10.1378/chest.129.5.1176.