drugset / Trial / NCT02261727

Theophylline and Steroids in Chronic Obstructive Pulmonary Disease (COPD) Study

NCT02261727

RandomizedParallel-groupTriple-blindTreatment

Summary

The aim of this multi-centre, double blind, randomised, controlled trial (DBRCT) is to assess the effect of low dose theophylline, singly and in combination with low dose oral prednisone, on COPD (Chronic Obstructive Pulmonary Disease) exacerbations, quality of life and secondary clinical outcomes compared with usual therapy and placebo over 48 weeks of treatment. 1670 symptomatic patients with COPD will be recruited in China for comparison of low dose theophylline versus placebo and low dose theophylline + low dose prednisone The primary end-point for this study is the annualised COPD exacerbation rate between the treatment groups. Secondary outcomes included time to first severe exacerbation requiring hospitalisation or death, health status, and pre- and post-bronchodilator spirometry.

Timeline

Start
2014-06
Primary completion
2018-05-14
Completion
2018-05-14

Drugs

EvaluationDrugModalityDoseRoute
Comparator Prednisone Other / unclassified 5 mg Oral
Comparator Theophylline Small molecule 100 mg Oral