Background: The effect of prophylactic nasal corticosteroids on wheezing episodes associated with colds was investigated in a 12 week parallel group, double blind, randomised controlled trial in preschool children.
Methods: Data were collected from 50 children aged 12-54 months with a history of at least three episodes of wheeze associated with colds over the previous winter, but few or no interval symptoms; 24 were given one dose of fluticasone aqueous nasal spray (50 micro g) into each nostril twice daily and 26 received an indistinguishable placebo spray. Episodes of lower respiratory illness occurring within 2 days of the onset of a cold were identified from daily symptom diaries. The main outcome was nocturnal symptom score during the first 7 days of an episode.
Results: The groups were well balanced on entry except that the treatment group had a history of more prolonged episodes. During the trial there was no significant difference in the number of episodes in the treatment and control groups (27 and 37, respectively), in the severity of nocturnal symptoms (mean score 1.33 and 1.22, respectively, confidence interval of difference -0.24 to +0.47) or in daytime symptoms, activity or total scores during episodes. Compliance was estimated to be over 50% in 43 of the children.
Conclusions: Nasal corticosteroid treatment does not prevent acute wheezy episodes associated with upper respiratory infections (common colds) in preschool children.