Chronic Obstructive Pulmonary Disease Clinical Trial
— TASCSOfficial title:
The Effect of Low-dose Corticosteroids and Theophylline on the Risk of Acute Exacerbations of COPD: the TASCS Randomised Clinical Trial
Verified date | August 2021 |
Source | The George Institute |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 1670 |
Est. completion date | May 14, 2018 |
Est. primary completion date | May 14, 2018 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 40 Years to 80 Years |
Eligibility | Inclusion Criteria: - Current or former smokers (> 10 pack years) or biomass exposure - 40 - 80 years of age - Clinical diagnosis of COPD - Post-bronchodilator FEV1 < 70% predicted - Post bronchodilator FEV1/FVC ratio < 0.7 Exclusion Criteria: - Life expectancy of less than 12 months - Exacerbation or respiratory infection within 4 weeks prior to randomisation - Patient is taking and requires maintenance oral corticosteroids - Patient is on domiciliary oxygen - There has been previous pulmonary resection - Previous sensitivity to, or intolerance of theophylline - Coexistent illness precluding participation in the study (epilepsy, chronic liver disease, unstable cardiovascular disease, diabetes, active malignancy) - Inability to complete quality of life questionnaire - Concomitant major illness that would interfere with visits, assessments and follow-up - Have evidence of chronic liver disease, or transaminase or gamma-glutamyltransferase (GGT) elevation > 1.5 x upper limit of normal (ULN) - Random blood glucose level > 8mmol/L - High chance in the view of the treating physician that the patient will not adhere to study treatment and follow up |
Country | Name | City | State |
---|---|---|---|
Australia | The George Institute for Global Health | Sydney | New South Wales |
Lead Sponsor | Collaborator |
---|---|
The George Institute | National Health and Medical Research Council, Australia |
Australia,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Hospitalisations | The total number of hospitalisation events within 48 weeks | 48 weeks | |
Primary | Total COPD Exacerbation Rate | The total number of COPD exacerbations reported within 48 weeks | 48 weeks observation; rate annualised | |
Secondary | Time to First COPD Exacerbation | The median time (days) from randomisation to first exacerbation per participant | Median time (days) from randomisation to first exacerbation over a 48 week period per participant | |
Secondary | Quality of Life Measured by St. George's Respiratory Questionnaire (SGRQ) | THe St. George's Respiratory Questionnaire (SGRQ) is a disease-specific instrument designed to measure impact on overall health, daily life, and perceived well-being in patients with obstructive airways disease. Scores range from 0 to 100, with higher scores indicating more limitations. | Change over 48 week study duration | |
Secondary | Post Bronchodilator FEV1 | The change in post bronchodilator FEV1 from baseline to 48 weeks | Change at 48 weeks | |
Secondary | Change in COPD Assessment Test (CAT) Score | The COPD Assessment Test (CAT) is a patient-completed questionnaire assessing globally the impact of COPD (cough, sputum, dysnea, chest tighteness) on health status. The range of CAT scores from 0-40. Higher scores denote a more severe impact of COPD on a patient's life. The outcome measure is assessing the change in score from baseline to 48 weeks. A negative change denotes an improvement in health status. | 48 weeks |
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