Low‐dose theophylline in childhood asthma: a placebo‐controlled, double‐blind study

Abstract

Regular anti-inflammatory treatment is essential in treating persistent asthma. Most commonly, inhaled corticosteroids (ICS) are used. However, especially in children, there is concern about the long-term safety of ICS such that doses should be kept to a minimum. The use of theophylline has decreased because of frequent side-effects in therapeutic doses. In adults, there have been reports about an immunomodulatory effect of low-dose theophylline. To study the clinical and immunomodulatory effect in children, 36 patients (mean age 12.5 SD 2.4 years) with moderate, persistent asthma on regular ICS were recruited into a placebo-controlled, double-blind study. After a 6-week run-in period, patients received either theophylline 10 mg/kg bodyweight or placebo for 12 weeks. Diary cards, lung function, peripheral blood lymphocyte subpopulations and serum eosinophil cationic protein (sECP) were assessed. In the treatment group, mean serum theophylline was 7.1 mg/l. There was no change in symptoms or use of rescue medication. Mean (SD) peak expiratory flow (PEF) increased from 86% (24) to 95% (18) predicted. sECP decreased from 43.2 microg/l (32.5) to 26.5 microg/l (16.9) (p = 0.02). Lymphocyte subpopulations did not change. The study failed to show a beneficial clinical or an immunomodulatory effect of theophylline when used in low doses. These results do not support a more important role of theophylline in the long-term treatment of moderate childhood asthma.

Status of Research in Respiratory Pharmacology in India during the last Five Years (2012-2017)

“…Theophylline, although effective is considered as the third-line therapy in the treatment of bronchial asthma due to the drug's frequent side effects. The low-dose of theophylline in moderate childhood asthma is safe and well tolerated (Suessmuth, 2003). At low doses, the drug is easier to use, side effects are uncommon and the problems of drug interaction are less of an issue, thus making the clinical use of theophylline less complicated.…”

Pediatric Asthma

“…70, 71 One small trial showed that the addition of theophylline to inhaled corticosteroids resulted in improvement in peak expiratory flow, but did not improve FEV1 or bronchial reactivity. 72 Given the lack of substantial supporting evidence, potential toxicity, and need for frequent monitoring, theophylline is not part of first-line therapy for children with asthma and is not recommended for children under 5. 5 …”