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A comparative trial of choline theophyllinate and controlled release aminophylline in chronic childhood asthma
Insights
Controlled-release aminophylline (Phyllocontin) demonstrated sustained plasma theophylline levels in children with asthma, significantly reducing nocturnal symptoms and improving daytime activity compared to standard oral theophylline (Choline Theophyllinate).
Area of Science:
- Pediatric Pulmonology
- Clinical Pharmacology
- Asthma Management
Background:
- Chronic asthma in children requires effective and consistent bronchodilator therapy.
- Standard oral theophylline preparations can exhibit variable plasma levels, potentially impacting therapeutic efficacy.
- Controlled-release formulations aim to provide more stable drug concentrations.
Purpose of the Study:
- To compare the pharmacokinetics and therapeutic effects of controlled-release aminophylline (Phyllocontin) versus standard oral theophylline (Choline Theophyllinate) in pediatric asthma.
- To evaluate the impact of different theophylline formulations on nocturnal symptoms and daytime activity.
- To assess the influence on peak plasma levels and the need for rescue bronchodilators.
Main Methods:
- Two parallel double-blind trials involving 25 children with chronic asthma.
- A subset of 14 children participated in a double-blind cross-over trial.
- Plasma theophylline levels, peak flow rates, symptom scores, and bronchodilator use were monitored.
Main Results:
- Controlled-release aminophylline achieved sustained plasma theophylline levels, unlike the low morning levels with Choline Theophyllinate.
- No significant differences were observed in peak theophylline levels, peak flow rates, or rescue bronchodilator use.
- Nocturnal asthma symptoms were significantly reduced, and daytime activity scores improved with controlled-release aminophylline (P < 0.05).
Conclusions:
- Sustained plasma theophylline levels from controlled-release aminophylline offer a modest but beneficial therapeutic advantage in pediatric asthma.
- Controlled-release formulations may improve symptom control and quality of life in children with chronic asthma.
- Further research into optimal dosing and long-term effects of controlled-release theophylline in pediatrics is warranted.
Abstract:
A comparison of pharmacokinetics and therapeutic effects of a standard oral theophylline preparation (Choline Theophyllinate) and controlled release aminophylline (Phyllocontin) was made in two parallel double blind trials in 25 children with chronic asthma. Fourteen children entered a double blind cross-over trial; the remaining 11 were allocated to a parallel trial with no change of theophylline preparation throughout. Sustained plasma theophylline levels were observed with the controlled release preparation in contrast to the low morning levels obtained with Choline Theophyllinate. No significant differences were found for peak theophylline levels, morning or evening peak flow rates or required access to other bronchodilators. However nocturnal symptoms were significantly reduced and daytime activity scores improved (P less than 0.05) on the controlled release preparation. The sustained plasma theophylline levels found in children taking the controlled release aminophylline may have provided a small but useful therapeutic advantage over the standard preparation.