Effect of inhaled corticosteroids on episodes of wheezing associated with viral infection in school age children: randomised double blind placebo controlled trial.
OBJECTIVE
To determine the effect of regular prophylactic inhaled corticosteroids on wheezing episodes associated with viral infection in school age children.


METHODS
Randomised, double blind, placebo controlled trial.


METHODS
Community based study in Southampton.


METHODS
104 children aged 7 to 9 years who had had wheezing in association with symptoms of upper and lower respiratory tract infection in the preceding 12 months.


METHODS
After a run in period of 2-6 weeks children were randomly allocated twice daily inhaled beclomethasone dipropionate 200 micrograms or placebo through a Diskhaler for 6 months with a wash out period of 2 months. Children were assessed monthly.


METHODS
Forced expiratory volume in 1 second (FEV1); bronchial responsiveness to methacholine (PD20); percentage of days with symptoms of upper and lower respiratory tract infection with frequency, severity, and duration of episodes of upper and lower respiratory symptoms and of reduced peak expiratory flow rate.


RESULTS
During the treatment period there was a significant increase in mean FEV1 (1.63 v 1.53 1; adjusted difference 0.09 1 (95% confidence interval 0.04 to 0.14); P = 0.001) and methacholine PD20 12.8 v 7.2 mumol/l; adjusted ratio of means 1.7 (1.2 to 2.4); P = 0.007) in children receiving beclomethasone dipropionate compared with placebo. There were, however, no significant differences in the percentage of days with symptoms or in the frequency, severity, or duration of episodes of upper or lower respiratory symptoms or of reduced peak expiratory flow rate during the treatment period between the two groups.


CONCLUSIONS
Although lung function is improved with regular beclomethasone dipropionate 400 micrograms/day, this treatment offers no clinically significant benefit in school age children with wheezing episodes associated with viral infection.
Doull
I J
IJ
University Medicine, Southampton General Hospital. doullij@cardiff.ac.uk
Lampe
F C
FC
Smith
S
S
Schreiber
J
J
Freezer
N J
NJ
Holgate
S T
ST
D000280:Administration, Inhalation; D018927:Anti-Asthmatic Agents / Q000008:administration & dosage*; D001507:Beclomethasone / Q000008:administration & dosage*; D002648:Child; D004311:Double-Blind Method; D005260:Female; D005541:Forced Expiratory Volume; D006801:Humans; D008297:Male; D016210:Methacholine Chloride; D009330:Nebulizers and Vaporizers; D010366:Peak Expiratory Flow Rate; D012135:Respiratory Sounds; D012141:Respiratory Tract Infections / Q000188:drug therapy* / Q000503:physiopathology / Q000821:virology; D014777:Virus Diseases / Q000188:drug therapy*
D018927:Anti-Asthmatic Agents; D016210:Methacholine Chloride; D001507:Beclomethasone