Once daily nebulized beclomethasone is effective in maintaining pulmonary function and improving symptoms in asthmatic children.
OBJECTIVE
Compliance with long-term inhaled therapy in asthma is often poor, but it is likely to be improved with a simplified administration, once daily. The present study was designed to assess whether, in childhood asthma, a single dose of nebulized beclomethasone dipropionate once daily was as effective and safe as the same total daily dose administered twice daily.


METHODS
Asthmatic children, not treated with inhaled steroids for at least a month preceding the study and using short-acting bronchodilators more than once a week were enrolled in a double-blind, double dummy, randomised, multicentric study. After a two week run-in period on nebulised twice daily 400 mcg beclomethasone dipropionate, patients were randomly assigned to twelve weeks of treatment with 800 mcg nebulised beclomethasone dipropionate daily, either in single dose (o.d. group) or divided into two 400 mcg doses (b.i.d. group).


RESULTS
65 children (mean age 8.6 years, mean FEV1 81% of predicted), were valuable for intention to treat. During the run-in period, a significant improvement in FEV1, FVC, morning and evening PEF values and clinical scores was observed. Children then entered the randomised trial: 32 were included in the o.d. group and 33 in the b.i.d. group. During the twelve week treatment period, the observed improvement in pulmonary function parameters was maintained in both treatment groups. Morning and evening PEF showed a progressive slight increase as well as PEF diurnal variability showed a progressive reduction in the two treatment groups during the whole study period without reaching statistical significance. Moreover, in both treatment groups a similar progressive increase in symptom free nights and days and in the percentage of children achieving total asthma symptoms control was detected. Finally, no significant changes in urinary cortisol/creatinine ratio were observed throughout the study period and between groups.


CONCLUSIONS
A daily dose of 800 mcg of beclomethasone, administered for twelve weeks with a nebuliser either once or twice daily provide similar efficacy in maintaining pulmonary function and symptoms of asthmatic children, with a good tolerability profile.
La Grutta
S
S
Children Hospital ARNAS, Palermo, Italy.
Nicolini
G
G
Capristo
C
C
Bellodi
S C
SC
Rossi
G A
GA
D018927:Anti-Asthmatic Agents / Q000008:administration & dosage* / Q000009:adverse effects / Q000378:metabolism; D001249:Asthma / Q000188:drug therapy* / Q000503:physiopathology*; D001507:Beclomethasone / Q000008:administration & dosage* / Q000009:adverse effects / Q000378:metabolism; D002648:Child; D002675:Child, Preschool; D002940:Circadian Rhythm / Q000187:drug effects; D003404:Creatinine / Q000652:urine; D004311:Double-Blind Method; D005260:Female; D005541:Forced Expiratory Volume / Q000187:drug effects*; D006801:Humans; D006854:Hydrocortisone / Q000652:urine; D008297:Male; D009330:Nebulizers and Vaporizers; D010349:Patient Compliance; D010366:Peak Expiratory Flow Rate / Q000187:drug effects*; D013147:Spirometry; D016896:Treatment Outcome; D014797:Vital Capacity / Q000187:drug effects*
D018927:Anti-Asthmatic Agents; D003404:Creatinine; D001507:Beclomethasone; D006854:Hydrocortisone