PMID- 17614270
OWN - NLM
STAT- MEDLINE
DCOM- 20080221
LR  - 20130530
IS  - 0954-6111 (Print)
IS  - 0954-6111 (Linking)
VI  - 101
IP  - 10
DP  - 2007 Oct
TI  - Randomized comparison of the efficacy and safety of ciclesonide and budesonide in 
      adolescents with severe asthma.
PG  - 2182-91
AB  - BACKGROUND: The aim of the study was to investigate the efficacy and safety of 
      ciclesonide compared with budesonide in adolescents with severe asthma. METHODS: 
      In this randomized, double-blind, double-dummy, parallel-group study, patients 
      aged 12-17 years with severe asthma were treated with budesonide 400 microg once 
      daily (QD) in a 2-week run-in period. At randomization, eligible patients were 
      assigned 2:1 to ciclesonide 320 microg QD (ex-actuator) or budesonide 800 microg 
      QD (metered dose), respectively, in the evening. Forced expiratory volume in 1s 
      (FEV(1)) was the primary variable. Patients recorded asthma symptom score and 
      rescue medication use in diaries. Safety assessments included adverse events 
      (AEs) and 24-h urine cortisol. RESULTS: Four hundred and three patients were 
      randomized. Ciclesonide 320 microg QD and budesonide 800 microg QD significantly 
      increased FEV(1) (least-squares mean: 505 and 536 mL, respectively; both p<0.0001 
      versus baseline) in the intention-to-treat (ITT) population. Lower limits of the 
      95% confidence intervals (ITT: -138 mL; per-protocol: -122 mL) were above the 
      non-inferiority limit (-150 mL). Median percentage of days without asthma 
      symptoms and without rescue medication use was 84% with ciclesonide and 85% with 
      budesonide. AEs were unremarkable, with no cases of confirmed candidiasis. Median 
      creatinine-adjusted urine cortisol significantly decreased with budesonide 
      treatment (15.9-13.7 nmol cortisol/mmol creatinine; p=0.0086 versus baseline), 
      but not with ciclesonide (p=0.1125). CONCLUSIONS: Ciclesonide 320 microg QD 
      showed similar efficacy to budesonide 800 microg QD in adolescents with severe 
      asthma. Ciclesonide was well tolerated and, unlike budesonide, had no effect on 
      urine cortisol levels. CLINICAL TRIAL REGISTRATION NUMBER: EudraCT No.: 
      2004-001233-41.
FAU - Vermeulen, J H
AU  - Vermeulen JH
AD  - Dorp Street 20, Panorama 7500, Cape Town, South Africa. jvm@iafrica.com
FAU - Gyurkovits, K
AU  - Gyurkovits K
FAU - Rauer, H
AU  - Rauer H
FAU - Engelstatter, R
AU  - Engelstatter R
LA  - eng
PT  - Journal Article
PT  - Multicenter Study
PT  - Randomized Controlled Trial
PT  - Research Support, Non-U.S. Gov't
DEP - 20070705
PL  - England
TA  - Respir Med
JT  - Respiratory medicine
JID - 8908438
RN  - 0 (Anti-Asthmatic Agents)
RN  - 0 (Bronchodilator Agents)
RN  - 0 (Pregnenediones)
RN  - 51333-22-3 (Budesonide)
RN  - S59502J185 (ciclesonide)
SB  - IM
MH  - Adolescent
MH  - Anti-Asthmatic Agents/*administration & dosage/adverse effects
MH  - Asthma/*drug therapy
MH  - Bronchodilator Agents/*administration & dosage/adverse effects
MH  - Budesonide/*administration & dosage/adverse effects
MH  - Child
MH  - Dose-Response Relationship, Drug
MH  - Female
MH  - Forced Expiratory Volume/drug effects
MH  - Humans
MH  - Male
MH  - Pregnenediones/*administration & dosage/adverse effects
MH  - Quality of Life/psychology
MH  - Treatment Outcome
MH  - Vital Capacity/drug effects
EDAT- 2007/07/07 09:00
MHDA- 2008/02/22 09:00
CRDT- 2007/07/07 09:00
PHST- 2007/02/12 00:00 [received]
PHST- 2007/05/04 00:00 [revised]
PHST- 2007/05/04 00:00 [accepted]
PHST- 2007/07/07 09:00 [pubmed]
PHST- 2008/02/22 09:00 [medline]
PHST- 2007/07/07 09:00 [entrez]
AID - S0954-6111(07)00193-X [pii]
AID - 10.1016/j.rmed.2007.05.006 [doi]
PST - ppublish
SO  - Respir Med. 2007 Oct;101(10):2182-91. doi: 10.1016/j.rmed.2007.05.006. Epub 2007 
      Jul 5.