Evaluation of a sustained-release theophylline tablet in young asthmatics

Area of Science:

• Pediatric Pulmonology
• Pharmacokinetics
• Asthma Management

Background:

• Asthma is a common chronic respiratory disease in children.
• Effective long-term asthma management in young children requires appropriate pharmacotherapy.
• Sustained-release theophylline (SRT) offers a potential therapeutic option for pediatric asthma.

Purpose of the Study:

• To evaluate the efficacy and pharmacokinetic profile of a sustained-release theophylline (SRT) tablet in children aged 3-5 years with moderately severe asthma.
• To assess the safety and tolerability of SRT in this pediatric population.
• To determine optimal dosing schedules for SRT in young asthmatic children.

Main Methods:

• A study involving 15 children (3-5 years) with moderately severe asthma.
• Administration of a mean daily dose of 20.4 mg/kg of SRT every 12 hours (q12h) for at least 3 weeks.
• Monitoring of daily symptom scores, twice-daily peak flow rates (PFR), and serum theophylline levels (STL) at various time points (0-12 hours, with some 24-hour samples).

Main Results:

• The mean peak STL was 16.6 +/- 4.4, with a trough of 5.9 +/- 2.8, and a peak-trough difference of 10.6 +/- 3.9.
• The average time to peak theophylline level was 3.9 hours.
• Average weekly morning and evening PFRs showed improvement over the 3-week treatment period, indicating effective bronchodilation.

Conclusions:

• The SRT tablet demonstrates efficacy in managing moderately severe asthma in young children when administered on a 12-hour dosage schedule.
• For a subset of children exhibiting significant peak-trough differences in serum theophylline levels, an 8-hour dosing schedule may be more appropriate.
• SRT is a viable treatment option for pediatric asthma, with potential for dose-schedule individualization.