All issues > Volume 50(3); 2007

Original Article

Korean J Pediatr. 2007;50(3):284-291. Published online March 15, 2007.

Therapeutic comparison between low-dose sustained-release theophylline dry syrup and capsule in children with mild persistent asthma

Hyun Seung HS Lee¹, Hae Kyung HK Lee², Hi Jeong HJ Kwon², Jeong Hee JH Kim³, Yeong Ho YH Rha⁴, Jin Tack JT Kim¹, Young Ho YH Kim⁵, Hae Rhan HR Lee⁵, Bok Yang BY Pyun⁶

¹Department of Pediatrics, College of Medicine The Catholic University of Korea, Seoul , Korea
²Department of Pediatrics, College of Medicine The Catholic University of Korea, Seoul, Korea
³Department of Pediatrics, College of Medicine, Inha University, Incheon, Korea
⁴Department of Pediatrics, College of Medicine, Kyunghee University, Seoul, Korea
⁵Department of Pediatrics, College of Medicine, Hallym University, Seoul, Korea
⁶Department of Pediatrics, College of Medicine, Soonchunhyang University∥, Seoul, Korea

Correspondence Jin Tack JT Kim ,Email: jintackk@catholic.ac.kr

Abstract

Purpose
: Theophylline has recently been reported to have concurrent anti-inflammatory effects at low therapeutic plasma concentrations which are below the doses at which significants, clinically useful bronchodilatation is evident. Sustained-release formulation in capsule and dry syrup forms were developed to reduce its adverse effects and improve its clinical effects. We compared the therapeutic effects of theophylline dry syrup and capsules in children with mild asthma.
Methods
: Ninety children with mild asthma were randomized to receive either theophylline dry syrup (n=44) or theophylline capsules (n=46); 4 mg per kilogram of body weight, twice a day, for 12 weeks. Baseline and serial measurements of daytime and nighttime asthma symptom score were performed. Compliance scores, drug swallowing scores, and drug usability scores were measured every 4 weeks. Each scoring was rated on a scale of 0-4. Serum theophylline concentration were measured at 4 and at 12 weeks. To examine the anti-inflammatory effect of theophylline on asthma, Serum eosinophilic cationic protein as a marker of airway inflammation caused by eosinophil was measured 12 weeks pre- and post-administration.
Results
: The daytime and nighttime asthma symptom scores of the two groups after 4 weeks significantly improved over the baseline score. Daytime and nighttime asthma symptom scores in the dry syrup group were statistically lower at all time points except for the nighttime symptom scores at 4 weeks. Compliance scores, drug swallowing scores, and drug usability scores in the dry syrup group were significantly higher at the end time point. Only in the dry syrup group was the serum ECP at the end time point statistically lower than baseline.
Conclusion
: Low-dose sustained-release theophylline may be safe and effective in bronchial asthma and this effect may be mediated by its anti-inflammatory action mechanisms. Especially, when used in children with asthma, dry syrup formulation is recommended because of its higher compliance than capsule formulation.

Keywords :Theophylline , Dry syrup , Asthma