Evaluation of efficacy and safety of doxofylline 800mg sustained release tablet in treatment of patients with COPD: an open label, prospective and RCT


  • Prakash Narayan Khandelwal Department of Pharmacology, Government Medical College, Aurangabad, Maharashtra, India
  • Syed H. Maaz Department of Pharmacology, Indian Institute of Medical Science and Research, Jalna, Maharashtra, India
  • Dhammraj M. Borade Medical advisor, Medical scientific affair, Wockhardt limited, Mumbai, Maharashtra, India




Chronic obstructive pulmonary disease, Doxofylline, Sustained release formulation


Background: COPD is a major cause of health care burden worldwide and leading cause of death that is increasing in prevalence. Methylxanthines are used in the treatment of patients with asthma and COPD. Doxofylline (methylxanthine) shows improved disease control, reduced total daily dose of inhaled b2 agonists and improved patient compliance.

Methods: This was a prospective, open labelled, randomized, two-arm, parallel group, controlled, clinical trial. 115 patients were randomized to two groups. Patients in group A received tablet doxofylline 400mg BD whereas patients in group B received tablet doxofylline 800mg SR for 4 weeks. Primary outcome measure of trial was change in FEV1 and secondary outcome measure were change in FVC/FEV1, change in symptoms score, effect on health-related quality of life (HRQOL) and safety of study medication.

Results: At 4 week the FEV1increase by 13.028% and 17.647% in group A and B respectively. In group A FEV1/FVC increase by 5.79% and in group B it increases by 9.57% at 4 weeks. The symptom score of cough decrease by 77.35% and 97.43% in group A and group B respectively at 4 weeks. In group A shortness of breath decrease by 77.60% and in group B it decreases by 95.90% at 4 weeks. Tightness in chest decrease by 86.29% and 98.40% in group A and group B respectively at 4 weeks.

Conclusions:Doxofylline 800mg sustained release tablet provided significantly greater improvement in FEV1, symptomatic control and health related quality of life compared to doxofylline 400mg.



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How to Cite

Khandelwal, P. N., H. Maaz, S., & Borade, D. M. (2018). Evaluation of efficacy and safety of doxofylline 800mg sustained release tablet in treatment of patients with COPD: an open label, prospective and RCT. International Journal of Basic & Clinical Pharmacology, 7(4), 644–649. https://doi.org/10.18203/2319-2003.ijbcp20181163



Original Research Articles