Theophylline and Steroids in Chronic Obstructive Pulmonary Disease (COPD) Study
Status:
Completed
Trial end date:
2018-05-14
Target enrollment:
Participant gender:
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.
Phase:
Phase 4
Details
Lead Sponsor:
The George Institute
Collaborator:
National Health and Medical Research Council, Australia