Trial results
AI generated results summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI
According to the results reported on ClinicalTrials.gov, this trial enrolled 1,670 people across three groups: one group received low-dose theophylline (a type of medication), one received a combination of theophylline and prednisone (a steroid), and one received a placebo (a dummy treatment with no active ingredient). All participants had COPD (a lung condition) and were followed for 48 weeks. The trial was primarily measuring how often participants had COPD flare-ups (called exacerbations) during that time. Not everyone finished the study — around 411–423 people per group completed it out of the 548–568 who started. The reported data shows that the placebo group had, on average, 1.00 flare-ups per person per year, compared to 0.86 in the low-dose theophylline group and 0.89 in the theophylline-and-prednisone group. For the secondary measures, the reported data shows that the median time (the midpoint — half of participants took longer, half took less time) before a first flare-up was 137 days in the placebo group, 150 days in the low-dose theophylline group, and 151 days in the combination group. On a quality-of-life questionnaire (where lower scores mean fewer limitations), all three groups showed a reduction in score from their starting point: −4.95 for placebo, −6.85 for low-dose theophylline, and −6.48 for the combination group. A separate symptom questionnaire (scored 0–40, with lower being better) also showed reductions from baseline in all groups: −2.29 for placebo, −2.77 for low-dose theophylline, and −2.57 for the combination. A breathing measurement (FEV1) changed only marginally in all three groups. The reported number of hospital admissions over 48 weeks was 120 in the placebo group, 101 in the low-dose theophylline group, and 122 in the combination group. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
These are the results as reported to ClinicalTrials.gov, not medical advice. Verify independently with the trial site and discuss what they mean for you with your doctor.
Phase 4 COPD Trial, Completed
Who may be able to join
AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI
Who might be able to join this trial:
- You are a current or past smoker (with a significant smoking history of more than 10 "pack years") or have had long-term exposure to smoke from burning wood, coal, or other solid fuels
- You are between 40 and 80 years old
- You have been diagnosed with COPD (a chronic lung condition that makes it hard to breathe)
- Your lung function test results show that your airways are significantly blocked, even after using a bronchodilator (an inhaler that opens up the airways) — specifically, two measurements from a breathing test (FEV1 and FEV1/FVC ratio) must meet certain levels (confirm with trial site)
Who may not be able to join:
- Your life expectancy is less than 12 months
- You have had a flare-up of your lung condition or a breathing-related infection in the 4 weeks before joining the trial
- You regularly take steroid tablets (such as prednisolone) by mouth and need to continue taking them
- You use oxygen at home on a regular basis
- You have previously had surgery to remove part of a lung
- You have had a bad reaction to, or cannot tolerate, a medicine called theophylline
- You have certain other serious health conditions, including epilepsy, chronic liver disease, unstable heart disease, diabetes, or active cancer
- You are unable to fill in a quality of life questionnaire
- You have another serious illness that would make it difficult to attend appointments or complete the study
- You have signs of liver disease, or your liver-related blood test results are above a certain level (confirm with trial site)
- Your blood sugar level from a routine test is above 8mmol/L
- Your doctor thinks it is unlikely that you would be able to stick to the treatment plan and attend follow-up appointments
Important: Always verify eligibility with the trial site directly before applying.
Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.
GP referral letter
Print a one-page summary to share with your doctor.
Trial details
Where this trial is recruiting
1 site(s) in Australia. Confirm current status and contact details directly with the trial site.
Primary endpoints
Total COPD Exacerbation Rate
Can't join this trial?
Data last synced from ClinicalTrials.gov: 2 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.