At a glance
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The Effect of Low-dose Corticosteroids and Theophylline on the Risk of Acute Exacerbations of COPD: the TASCS Randomised Clinical Trial
In Brief
A Phase 4 clinical trial evaluating Theophylline, Prednisone, and 2 other interventions for Chronic Obstructive Pulmonary Disease. Completed, enrolled 1,670 participants across 1 site.
Detailed 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.
Study Details
Timeline
Interventions
Theophylline is an oral methylxanthine which relaxes smooth muscle through its action as a phosphodiesterase inhibitor
Prednisone is an oral glucocorticosteroid which has anti-inflammatory properties
* Arm 1 : Theophylline Placebo 1 tab twice daily and Prednisone placebo 1 tab once daily * Arm 2 : Theophylline 100mg 1 tab twice daily and Prednisone placebo 1 tab once daily
One tablet twice daily in arm 1 (theophylline placebo 1 BD + prednisone placebo 1 once daily)