Theophylline and Steroids in Chronic Obstructive Pulmonary Disease (COPD) Study (NCT02261727) | Clinical Trial Compass
CompletedPhase 4
Theophylline and Steroids in Chronic Obstructive Pulmonary Disease (COPD) Study
Australia1,670 participantsStarted 2014-06
Plain-language 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.
Who can participate
Age range
40 Years – 80 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.