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Long-term treatment of children with sustained-release theophylline
Insights
Sustained-release theophylline (SRT) effectively manages severe childhood asthma long-term. After one year, SRT significantly improved asthma control compared to placebo, highlighting the need for ongoing patient assessment.
Area of Science:
- Pediatric Pulmonology
- Pharmacology
Background:
- Severe perennial asthma in children poses significant management challenges.
- Long-term efficacy of sustained-release theophylline (SRT) requires ongoing evaluation.
Purpose of the Study:
- To assess the long-term efficacy of sustained-release theophylline (SRT) in children with severe perennial asthma.
- To compare asthma control after one year of SRT treatment versus placebo.
Main Methods:
- A 6-week, randomized, double-blind, placebo-controlled crossover study involving 19 children.
- Asthma severity was evaluated before SRT treatment and during the SRT and placebo periods after one year.
Main Results:
- After one year, asthma parameters significantly improved during the placebo period compared to pre-treatment levels.
- Theophylline treatment significantly improved most parameters compared to placebo, with a mean serum theophylline level of 13.3 mg/l.
- Improvements were noted in lung function and reduced acute attacks, though not all parameters showed significant change.
Conclusions:
- Sustained-release theophylline (SRT) demonstrates sustained efficacy in managing severe childhood asthma after one year.
- Regular re-evaluation is crucial for children on continuous prophylactic asthma treatment.
Abstract:
After one year of sustained-release theophylline (SRT) treatment, 19 children with severe perennial asthma participated in a 6-week, placebo-controlled, randomized, double-blind cross-over study. The severity of their asthma was evaluated before SRT-treatment (pre-period) and one year later, both during the theophylline period and the placebo period of the double-blind study. Compared with the pre-period, all observed parameters, except the number of extra bronchodilators required, were statistically significantly improved in the placebo period of the double-blind trial performed after one year. In addition, except for peak expiratory flow measured at home and the number of acute attacks, all parameters were significantly improved during the theophylline period when compared with placebo treatment. During this study, mean serum theophylline level was 13.3 mg/l (range 7.8-19.4 mg/l). The results show that theophylline remains efficient after one year's administration. The much better control of the children's asthma following one year of treatment emphasizes the need for regular re-evaluation of children receiving continuous prophylactic treatment.