Phase 4
Completed N=1,670
Theophylline and Steroids in Chronic Obstructive Pulmonary Disease (COPD) Study
Source: ClinicalTrials.gov NCT02261727 ↗Enrolled (actual)
1,670
Serious AEs
16.2%
Results posted
Aug 2021
Primary outcomePrimary: Total COPD Exacerbation Rate — 1.00; 0.86; 0.89 Exacerbations per participant year
◆ Published Evidence
Established
35citations · ~7 / year
The effect of low-dose corticosteroids and theophylline on the risk of acute exacerbations of COPD: the TASCS randomised controlled trial.
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.
Linked Publications
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The effect of low-dose corticosteroids and theophylline on the risk of acute exacerbations of COPD: the TASCS randomised controlled trial.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Total COPD Exacerbation Rate |
1.00; 0.86; 0.89 | — |
| SECONDARY Time to First COPD Exacerbation |
137; 150; 151 | — |
| SECONDARY Quality of Life Measured by St. George's Respiratory Questionnaire (SGRQ) |
-4.95; -6.85; -6.48 | — |
| SECONDARY Post Bronchodilator FEV1 |
-0.02; -0.01; -0.02 | — |
| SECONDARY Change in COPD Assessment Test (CAT) Score |
-2.29; -2.77; -2.57 | — |
Eligibility Criteria
Inclusion Criteria
- Current or former smokers (> 10 pack years) or biomass exposure
- 40 - 80 years of age
- Clinical diagnosis of COPD
- Post-bronchodilator FEV1 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
Data sourced from ClinicalTrials.gov (NCT02261727) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.