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Prednisolone oral solution plus inhaled procaterol for acute asthma in children: a double-blind randomized controlled
Li-Hsin Huang1, Shyh-Dar Shyur, Da-Chin Wen
1Allergy and Immunology Section, Department of Pediatrics, Mackay Memorial Hospital, Taipei, Taiwan.
Insights
Prednisolone sodium phosphate oral solution and tablets are equally effective for treating acute childhood asthma when combined with inhaled procaterol. Both treatments significantly improved lung function and symptoms over seven days.
Area of Science:
- Pediatric Pulmonology
- Clinical Pharmacology
- Asthma Management
Background:
- Acute asthma exacerbations in children require effective treatment strategies.
- Evaluating novel drug delivery systems for corticosteroids is crucial.
Purpose of the Study:
- To compare the efficacy of oral prednisolone sodium phosphate solution versus oral prednisolone tablets.
- Both formulations were administered with inhaled procaterol for acute childhood asthma.
Main Methods:
- A double-blind, randomized trial involved 43 children (6-12 years) with acute asthma.
- Patients received either oral solution or tablets, plus procaterol, for 7 days.
- Key outcomes included peak expiratory flow rate (PEFR), spirometry, and symptom scores.
Main Results:
- Both treatment groups showed significant improvements in PEFR, pulmonary index score (PIS), and symptom scores.
- No statistically significant differences were observed between the oral solution and tablet groups for any measured parameter.
- Lung function tests (FEV1, FEV1/FVC, FEF25-75%) also showed comparable improvements in both groups.
Conclusions:
- Prednisolone sodium phosphate oral solution is as effective as prednisolone tablets for managing acute pediatric asthma.
- The findings support the use of oral solutions as a viable alternative for corticosteroid delivery in children.
- Combined therapy with inhaled procaterol demonstrated efficacy in both formulations.
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.
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