PMID- 11860218
OWN - NLM
STAT- MEDLINE
DCOM- 20020401
LR  - 20131121
IS  - 1128-3602 (Print)
IS  - 1128-3602 (Linking)
VI  - 5
IP  - 1
DP  - 2001 Jan-Feb
TI  - Beclomethasone dipropionate versus budesonide inhalation suspension in children 
      with mild to moderate persistent asthma.
PG  - 17-24
AB  - Inhaled steroids are the most effective long-term treatment of persistent asthma 
      but many children are unable to use correctly the available inhalers. 
      Administration of nebulized corticosteroids has some advantages over the 
      administration with pressurised metered-dose inhalers (pMDls). The objective of 
      this multicenter randomised study was to compare the efficacy and tolerability of 
      nebulized corticosteroids in paediatric patients with asthma. 127 patients aged > 
      or = 6 and < or = 14 years with a diagnosis of mild to moderate persistent asthma 
      (PEFR % predicted > 50% and < 85%) and positive response to the reversibility 
      test were randomized. The patients were assigned by randomisation to one of the 
      two treatment groups (4 weeks): beclomethasone dipropionate (BDP) 800 
      microg/daily b.i.d. (n = 66) or budesonide (BUD) 1000 microg/daily b.i.d. (n = 
      61) both administered by nebulizer. The primary efficacy end point was the final 
      mean of PEFR measured at clinical visit (clinic PEFR). In the BDP group clinic 
      PEFR increased from 177.5 +/- 80 L/min to 246.6 +/- 84.2 L/min (p < 0.001 vs 
      baseline), while in the BUD group the increase was from 180.4 +/- 77.8/min to 
      260.9 +/- 84.1 L/min (p < 0.001 vs baseline) (NS between treatments). FEV1 (% 
      predicted) increased from 77.8% to 92.7% (p < 0.001 vs baseline) and from 74.1% 
      to 95.9% (p < 0.001 vs baseline) in BDP and BUD group respectively (NS between 
      treatments). Patients reduced the use of salbutamol rescue medication by 76% and 
      81% in BDP and BUD group respectively (p < 0.001 vs baseline, NS between 
      treatments). 4 patients in the BDP group and 2 in the BUD group reported adverse 
      events (AEs). AEs were mild to moderate and never there was the need to 
      discontinue the treatments. In conclusion the results of this study demonstrate 
      that both BDP (800 microg/daily) and BUD (1000 microg/daily) administered by 
      nebulization are effective and with a acceptable safety and tolerability profile.
FAU - Terzano, C
AU  - Terzano C
AD  - University La Sapienza, Rome, Italy.
FAU - Allegra, L
AU  - Allegra L
FAU - Barkai, L
AU  - Barkai L
FAU - Cremonesi, G
AU  - Cremonesi G
LA  - eng
PT  - Clinical Trial
PT  - Comparative Study
PT  - Journal Article
PT  - Multicenter Study
PT  - Randomized Controlled Trial
PT  - Research Support, Non-U.S. Gov't
PL  - Italy
TA  - Eur Rev Med Pharmacol Sci
JT  - European review for medical and pharmacological sciences
JID - 9717360
RN  - 0 (Anti-Asthmatic Agents)
RN  - 0 (Bronchodilator Agents)
RN  - 0 (Suspensions)
RN  - 51333-22-3 (Budesonide)
RN  - KGZ1SLC28Z (Beclomethasone)
SB  - IM
MH  - Administration, Inhalation
MH  - Adolescent
MH  - Analysis of Variance
MH  - Anti-Asthmatic Agents/adverse effects/*therapeutic use
MH  - Asthma/*drug therapy
MH  - Beclomethasone/adverse effects/*therapeutic use
MH  - Bronchodilator Agents/adverse effects/*therapeutic use
MH  - Budesonide/adverse effects/*therapeutic use
MH  - Chi-Square Distribution
MH  - Child
MH  - Confidence Intervals
MH  - Female
MH  - Humans
MH  - Male
MH  - Statistics, Nonparametric
MH  - Suspensions
EDAT- 2002/02/28 10:00
MHDA- 2002/04/02 10:01
CRDT- 2002/02/28 10:00
PHST- 2002/02/28 10:00 [pubmed]
PHST- 2002/04/02 10:01 [medline]
PHST- 2002/02/28 10:00 [entrez]
PST - ppublish
SO  - Eur Rev Med Pharmacol Sci. 2001 Jan-Feb;5(1):17-24.