PMID- 20958119
OWN - NLM
STAT- MEDLINE
DCOM- 20110224
LR  - 20131121
IS  - 1744-7666 (Electronic)
IS  - 1465-6566 (Linking)
VI  - 11
IP  - 17
DP  - 2010 Dec
TI  - Efficacy and safety of ciclesonide in patients with severe asthma: a 12-week, 
      double-blind, randomized, parallel-group study with long-term (1-year) follow-up.
PG  - 2791-803
LID - 10.1517/14656566.2010.526603 [doi]
AB  - OBJECTIVE: To investigate the efficacy and safety of ciclesonide in patients with 
      severe asthma over a 1-year period. RESEARCH DESIGN AND METHODS: Patients aged 18 
      - 75 years with persistent asthma were enrolled in a 12-week, double-blind, 
      randomized study and treated with ciclesonide 320 or 640 mug twice daily (b.i.d.) 
      with the option of continuing in a 40-week extension phase (EP). MAIN OUTCOMES 
      MEASURES: Change in morning peak expiratory flow (PEF) from baseline to 12 weeks 
      and safety over 1 year. RESULTS: 365 patients were randomized and 275 continued 
      into the EP. During 12 weeks' treatment, morning peak expiratory flow 
      significantly increased by 16 l/min (p < 0.001) and 14 l/min (p = 0.001) in the 
      320 and 640 mug b.i.d. groups, respectively. Both doses significantly reduced 
      total asthma symptom scores by 0.29 (p < 0.0001). In both groups, the incidence 
      of adverse effects (AEs) was low and mean cortisol levels in serum and urine were 
      not suppressed during the EP. CONCLUSIONS: Ciclesonide 320 mug b.i.d. sustained 
      lung function and asthma symptoms in patients with severe asthma over 12 weeks' 
      treatment, and maintained lung function during a 40-week EP; ciclesonide 640 mug 
      b.i.d. did not provide additional benefits. Long-term use of ciclesonide was not 
      associated with increased local AEs or negative effects on cortisol levels.
FAU - O'Connor, Brian J
AU  - O'Connor BJ
AD  - King's College London, School of Medicine, The London Chest Clinic, London, UK. 
      brian.oconnor@londonchestclinic.com
FAU - Kilfeather, Stephen
AU  - Kilfeather S
FAU - Cheung, David
AU  - Cheung D
FAU - Kafe, Henri
AU  - Kafe H
FAU - Blagden, Mark D
AU  - Blagden MD
FAU - Schlosser, Noel
AU  - Schlosser N
FAU - Ayres, Jon G
AU  - Ayres JG
FAU - Weber, Hans-Jochen
AU  - Weber HJ
FAU - Engelstatter, Renate
AU  - Engelstatter R
LA  - eng
PT  - Journal Article
PT  - Randomized Controlled Trial
PT  - Research Support, Non-U.S. Gov't
DEP - 20101019
PL  - England
TA  - Expert Opin Pharmacother
JT  - Expert opinion on pharmacotherapy
JID - 100897346
RN  - 0 (Anti-Asthmatic Agents)
RN  - 0 (Pregnenediones)
RN  - S59502J185 (ciclesonide)
RN  - WI4X0X7BPJ (Hydrocortisone)
SB  - IM
MH  - Administration, Inhalation
MH  - Adult
MH  - Aged
MH  - Anti-Asthmatic Agents/administration & dosage/adverse effects/*therapeutic use
MH  - Asthma/*drug therapy/physiopathology
MH  - Dose-Response Relationship, Drug
MH  - Double-Blind Method
MH  - Drug Administration Schedule
MH  - Female
MH  - Follow-Up Studies
MH  - Forced Expiratory Volume/drug effects
MH  - Humans
MH  - Hydrocortisone/blood/urine
MH  - Male
MH  - Middle Aged
MH  - Pregnenediones/administration & dosage/adverse effects/*therapeutic use
EDAT- 2010/10/21 06:00
MHDA- 2011/02/25 06:00
CRDT- 2010/10/21 06:00
PHST- 2010/10/21 06:00 [entrez]
PHST- 2010/10/21 06:00 [pubmed]
PHST- 2011/02/25 06:00 [medline]
AID - 10.1517/14656566.2010.526603 [doi]
PST - ppublish
SO  - Expert Opin Pharmacother. 2010 Dec;11(17):2791-803. doi: 
      10.1517/14656566.2010.526603. Epub 2010 Oct 19.