PMID- 20619624
OWN - NLM
STAT- MEDLINE
DCOM- 20110222
LR  - 20131121
IS  - 1532-3064 (Electronic)
IS  - 0954-6111 (Linking)
VI  - 104
IP  - 11
DP  - 2010 Nov
TI  - Efficacy and safety of three ciclesonide doses vs placebo in children with 
      asthma: the RAINBOW study.
PG  - 1618-28
LID - 10.1016/j.rmed.2010.06.012 [doi]
AB  - OBJECTIVE: To evaluate the efficacy and safety of three doses of ciclesonide 
      (with or without spacer) in children with persistent asthma. PATIENTS AND 
      METHODS: This was a multicentre, double-blind, placebo-controlled, 12-week study 
      of ciclesonide 40, 80 or 160 mug (once daily pm). Children (6-11 years) were 
      randomised 1:1 to treatment via a metered dose inhaler (MDI) or MDI plus spacer. 
      The primary variable was change from baseline in mean morning peak expiratory 
      flow (PEF). Secondary variables included: time to first lack of efficacy (LOE), 
      asthma control, forced expiratory volume in 1 s (FEV(1)), asthma symptom score 
      and quality of life (QoL). Safety assessments included: adverse events (AEs), 
      urinary cortisol excretion and body height. RESULTS: In total, 1073 children 
      received treatment. At endpoint, mean morning PEF significantly improved with all 
      doses of ciclesonide vs. placebo. There was no difference over placebo in time to 
      first LOE, but ciclesonide was superior to placebo on asthma control, symptom 
      score, FEV(1) and QoL. There were no differences between the spacer or non-spacer 
      subgroups. The incidences of AEs were comparable between treatment groups 
      (approximately 35%) and there were no between-group differences in body height or 
      urinary cortisol. CONCLUSIONS: Ciclesonide 40-160 mug once daily is effective and 
      well tolerated in children with persistent asthma; its efficacy and safety are 
      unaffected by the use of a spacer. clinicaltrials.gov registration number: 
      NCT00384189.
CI  - Copyright (c) 2010 Elsevier Ltd. All rights reserved.
FAU - Pedersen, Soren
AU  - Pedersen S
AD  - University of Southern Denmark, Pediatric Research Unit, Kolding Hospital, 
      Kolding, Denmark. sp@spconforsk.dk
FAU - Potter, Paul
AU  - Potter P
FAU - Dachev, Svetoslav
AU  - Dachev S
FAU - Bosheva, Miroslava
AU  - Bosheva M
FAU - Kaczmarek, Jadwiga
AU  - Kaczmarek J
FAU - Springer, Ewa
AU  - Springer E
FAU - Dunkel, Jochen
AU  - Dunkel J
FAU - Engelstatter, Renate
AU  - Engelstatter R
LA  - eng
SI  - ClinicalTrials.gov/NCT00384189
PT  - Journal Article
PT  - Multicenter Study
PT  - Randomized Controlled Trial
PT  - Research Support, Non-U.S. Gov't
DEP - 20100708
PL  - England
TA  - Respir Med
JT  - Respiratory medicine
JID - 8908438
RN  - 0 (Anti-Inflammatory Agents)
RN  - 0 (Pregnenediones)
RN  - S59502J185 (ciclesonide)
RN  - WI4X0X7BPJ (Hydrocortisone)
SB  - IM
MH  - Administration, Inhalation
MH  - Anti-Inflammatory Agents/*therapeutic use
MH  - Asthma/*drug therapy/physiopathology/urine
MH  - Body Height
MH  - Child
MH  - Double-Blind Method
MH  - Female
MH  - Humans
MH  - Hydrocortisone/*therapeutic use/urine
MH  - Male
MH  - Metered Dose Inhalers
MH  - Pregnenediones/*therapeutic use
MH  - Respiratory Function Tests/*methods
MH  - Treatment Outcome
EDAT- 2010/07/14 06:00
MHDA- 2011/02/23 06:00
CRDT- 2010/07/13 06:00
PHST- 2010/03/02 00:00 [received]
PHST- 2010/06/14 00:00 [revised]
PHST- 2010/06/15 00:00 [accepted]
PHST- 2010/07/13 06:00 [entrez]
PHST- 2010/07/14 06:00 [pubmed]
PHST- 2011/02/23 06:00 [medline]
AID - S0954-6111(10)00291-X [pii]
AID - 10.1016/j.rmed.2010.06.012 [doi]
PST - ppublish
SO  - Respir Med. 2010 Nov;104(11):1618-28. doi: 10.1016/j.rmed.2010.06.012. Epub 2010 
      Jul 8.