Guangdong Medtech Xinghua Pharmaceutical Co. Ltd (Guangzhou, Guangdong province of China) provided the theophylline and placebo for this study. However, Guangdong Medtech Xinghua Pharmaceutical Co. Ltd was not involved in the design of this study and no financial support was provided to the authors.
Positive benefits of theophylline in a randomized, double-blind, parallel-group, placebo-controlled study of low-dose, slow-release theophylline in the treatment of COPD for 1 year
Article first published online: 3 AUG 2006
Volume 11, Issue 5, pages 603–610, September 2006
How to Cite
ZHOU, Y., WANG, X., ZENG, X., QIU, R., XIE, J., LIU, S., ZHENG, J., ZHONG, N. and RAN, P. (2006), Positive benefits of theophylline in a randomized, double-blind, parallel-group, placebo-controlled study of low-dose, slow-release theophylline in the treatment of COPD for 1 year. Respirology, 11: 603–610. doi: 10.1111/j.1440-1843.2006.00897.x
- Issue published online: 3 AUG 2006
- Article first published online: 3 AUG 2006
- Received 12 December 2005; invited to revise 19 February 2006; revised 8 March 2006; accepted 15 March 2006 (Associate Editor: Toshihiro Nukiwa).
- drug therapy;
- pulmonary disease;
- randomized controlled trial;
- slow-release theophylline
Objective and background: Increasing evidence suggests that low-dose theophylline has anti-inflammatory benefits and is safe in the treatment of COPD. This study aims to evaluate the efficacy and safety of low-dose, slow-release oral theophylline administered over a 1-year period in patients with COPD.
Methods: A randomized, double-blind, parallel-group, placebo-controlled trial was carried out. In total, 110 participants with COPD were randomly assigned to receive slow-release theophylline (100 mg b.i.d.) or placebo for 1 year. Use of medicine and symptoms recorded by diary cards; pulmonary function, exacerbations of COPD, quality of life and the use of rescue medicine were evaluated. Superiority test was used to estimate the efficacy.
Results: Of 110 participants, 85 (77.3%) complied with the protocol, with 42 subjects in theophylline and 43 subjects on placebo. In both intention-to-treat and per-protocol population analysis, greater improvement in pre-bronchodilator FEV1 (P = 0.038 and P = 0.070, respectively), lower frequency of COPD exacerbations (P = 0.047 and P = 0.035, respectively), fewer days of COPD exacerbations (P = 0.045 and P = 0.046, respectively), lower frequency of clinical visits (P = 0.017 and P = 0.039, respectively), greater improvement in satisfaction with treatment (P = 0.014 and P = 0.004, respectively) were found in the theophylline group than in the placebo group. In per-protocol population, greater improvements in quality of life (P = 0.047) were also observed in the theophylline group and the mean time to the first exacerbation was delayed in theophylline group in comparison with placebo group (P = 0.047). Drug-related adverse events such as stomach discomfort (3.51%), headache (3.51%), insomnia (1.75%) and palpitation (1.75%) were found in the theophylline group.
Conclusions: Low-dose, slow-release oral theophylline is effective and well-tolerated in the long term treatment of stable COPD, although it does not improve post-bronchodilator lung function.