Prednisolone oral solution plus inhaled procaterol for acute asthma in children: a double-blind randomized controlled trial.
BACKGROUND
To evaluate the efficacy of prednisolone sodium phosphate oral solution plus inhaled procaterol in the treatment of acute asthma in children.


METHODS
Forty-three patients aged 6 to 12 years with an acute exacerbation of asthma were double-blind randomized into one of two treatment groups in a 1:1 ratio:1) prednisolone oral solution +placebo tablets + procaterol MDI or 2) prednisolone tablets +placebo oral solution + procaterol MDI, all given three times daily for 7 days. Peak expiratory flow rate (PEFR), 24-hour reflective asthma symptom scores, spirometry and pulmonary index score (PIS) were recorded before and after treatment. Net changes in PEFR, symptom score, PIS, Forced Expiratory Volume in the first second (FEV1), FEV1/forced vital capacity (FVC), forced expiratory flow between 25 and 75 percent of the forced vital capacity (FEF(25-75%)) (before and after treatment) and global assessment by the investigator and the subjects or their parents were analyzed.


RESULTS
The two groups were statistically similar at baseline values of these parameters. After a 7-day course of treatment, the net change of PEFR before and after treatment was significantly improved in both groups, but there was no significant difference in the net change of PEFR between the two groups (57.27+/-31.44 L/min vs. 54.29 +/-30.04 L/min, difference 2.99 +/-30.76 L/min, mean +/-SD, P=0.752). The net change in PIS and total symptom score did not differ between the two groups (P=0.091 and 0.827, respectively). Similarly, the FEV1, FEV1/FVC and FEF25-75% all improved with either treatment, and neither group was significantly superior to the other group (P=0.162, 0.48 and 0.081, respectively). Global assessment by the investigator and the subjects or their parents at the end of study indicated an essentially comparable result.


CONCLUSIONS
Prednisolone sodium phosphate oral solution plus inhaled procaterol is as efficacious as prednisolone tablets plus inhaled procaterol in the management of acute asthma in children.
Huang
Li-Hsin
LH
Allergy and Immunology Section, Department of Pediatrics, Mackay Memorial Hospital, Taipei, Taiwan.
Shyur
Shyh-Dar
SD
Wen
Da-Chin
DC
Chang
Yi-Chi
YC
Ma
Yi-Chun
YC
Lin
Sheng-Chieh
SC
Wu
Wen-Chiu
WC
Wu
Jiunn-Yi
JY
D000208:Acute Disease; D000280:Administration, Inhalation; D000284:Administration, Oral; D001249:Asthma / Q000188:drug therapy* / Q000503:physiopathology; D002648:Child; D002675:Child, Preschool; D004311:Double-Blind Method; D005260:Female; D005541:Forced Expiratory Volume / Q000187:drug effects; D006801:Humans; D008297:Male; D011239:Prednisolone / Q000008:administration & dosage*; D017265:Procaterol / Q000008:administration & dosage*
D011239:Prednisolone; D017265:Procaterol