NCT02261727

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

The Effect of Low-dose Corticosteroids and Theophylline on the Risk of Acute Exacerbations of COPD: the TASCS Randomised Clinical Trial

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 1,670 (actual)
• Sponsor: The George Institute · Academic / Other
• Sex: All
• Age: 40 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Detailed description

The investigators hypothesise that patients with COPD will have beneficial responses to low dose theophylline and prednisone, superior to placebo and low dose theophylline alone, reflected by a range of clinical outcomes. The study aims to demonstrate that treatment with low dose oral prednisone and low dose, slow release theophylline compared to low dose, slow release theophylline only or placebo will reduce COPD exacerbations and improve a range of secondary outcomes including quality of life, COPD Assessment Test (CAT) score, hospital admissions and lung function. Eligible participants will be randomised to one of three treatment arms in a DBRCT and will receive placebo OR low-dose theophylline (100 mg twice a day) OR low-dose theophylline 100 mg twice a day (BD) plus low-dose prednisone (5 mg once a day) Patients will be eligible for inclusion if all the following criteria are met: * Current or former smokers (\>10 pack years) or biomass exposure * 40 - 80 years of age * Clinical diagnosis of COPD * Post-bronchodilator forced expiratory volume at one second (FEV1) \<70% predicted * Post bronchodilator FEV1/forced vital capacity (FVC) ratio\<0.7

Conditions

• Chronic Obstructive Pulmonary Disease

Interventions

Type	Name	Description
DRUG	Theophylline	Theophylline is an oral methylxanthine which relaxes smooth muscle through its action as a phosphodiesterase inhibitor
DRUG	Prednisone	Prednisone is an oral glucocorticosteroid which has anti-inflammatory properties
DRUG	Placebo (for prednisone)	* 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
DRUG	Placebo (for Theophylline)	One tablet twice daily in arm 1 (theophylline placebo 1 BD + prednisone placebo 1 once daily)

Timeline

• Start date: 2014-06-01
• Primary completion: 2018-05-14
• Completion: 2018-05-14
• First posted: 2014-10-10
• Last updated: 2021-08-12
• Results posted: 2021-08-12

Locations

1 site across 1 country: Australia