A prospective clinical study of theophylline safety in 3810 elderly with asthma or COPD

Ken Ohta, Yoshinosuke Fukuchi, Lawrence Grouse, Ryuji Mizutani, Klaus F. Rabe, Stephen I. Rennard, Nan Shan Zhong

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50 Scopus citations


A large-scale prospective study was conducted in 3810 Japanese elderly (≥65 years old) patients with asthma or chronic obstructive pulmonary disease (COPD) who had been treated with sustained-release theophylline tablets (THEODUR®) at a dose of 400 mg/day for 1-6 months, in principle. Among 3798 protocol-complying patients (mean age: 73.8±0.10 years, 1997 with COPD), 261 theophylline-related adverse events were observed in 179 (4.71%) patients. The 5 most frequently observed adverse events were "nausea" (40 episodes, 1.05%), "loss of appetite" (22 episodes, 0.56%), "hyperuricemia" (16 episodes, 0.42%), "palpitation" (15 episodes, 0.39%), and "increased alkaline phosphatase" (11 episodes, 0.28%). No convulsions were reported. Six patients had serious adverse events. The incidence of theophylline-related adverse events was higher in patients with hepatic disease (odds ratio: 1:1.81) and in patients with arrhythmia (odds ratio: 1:1.88). Blood drug concentration measurements in 736 patients indicated that the drug levels were ≤15 μg/ml in 641 patients (87.1%), and no correlation was noted between dose and theophylline-related adverse events. These results suggest that sustained-release theophylline can be used safely in elderly patients with asthma or COPD.

Original languageEnglish (US)
Pages (from-to)1016-1024
Number of pages9
JournalRespiratory Medicine
Issue number10
StatePublished - Oct 2004


  • Adverse event
  • Bronchial asthma
  • Chronic obstructive pulmonary disease
  • Japanese elderly
  • Theophylline

ASJC Scopus subject areas

  • Pulmonary and Respiratory Medicine


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