A prospective study was undertaken to evaluate the efficacy of (sodium
) cromoglycate in the treatment of persistent wheezing in 31 children
between 4 and 12 months of age. The subjects were randomised to receiv
e either 40 mg of cromoglycate (n = 16) or physiological saline as pla
cebo (n = 15) three times a day by wet nebulisation in a double blind
fashion for a period of six weeks. The patients were evaluated with da
ily symptom scores expiratory flow at functional residual capacity (V(
max)FRC) before initiating treatment and upon completion. At baseline,
mean (SD) symptom scores between the two groups were comparable (crom
oglycate 99.5 (29.8), placebo 104.5 (29.7)) as were V(max)FRC expresse
d as per cent of predicted normals (cromoglycate 48 (28), placebo 46 (
20)). Upon completion of the treatment protocol, no significant differ
ence could be found between the two groups for either symptom score (c
romoglycate 67.6 (40.2), placebo 58.6 (41.4)), or V(max)FRC (cromoglyc
ate 52 (24), placebo 60 (32)). It is concluded, therefore, that 40 mg
of cromoglycate three times a day administered via facemask and wet ne
bulisation was no more effective than placebo in the treatment of our
sample of persistently wheezing infants under 1 year of age.