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 765 people in the roflumilast group and 758 people in the placebo group — a total of 1,523 participants — all of whom had a lung condition called COPD (chronic obstructive pulmonary disease). The trial was measuring two main things: changes in a breathing test called FEV1 (which measures how much air a person can forcefully breathe out in one second), and the rate at which participants experienced moderate or severe COPD flare-ups (called exacerbations) over the course of the study. Of those who started, 502 in the roflumilast group and 525 in the placebo group completed the trial. The reported data shows that, on average, participants taking roflumilast had a change of +46 millilitres in their pre-bronchodilator FEV1 breathing test from the start of the study, compared with +8 millilitres in the placebo group. For the post-bronchodilator FEV1 (measured after using a reliever inhaler), the reported figures were +57 millilitres for roflumilast and +8 millilitres for placebo. Regarding flare-ups, the reported rate was approximately 1.08 flare-ups per person per year in the roflumilast group, compared with approximately 1.27 in the placebo group. The reported data also shows results for several secondary measurements. The average time recorded until death from any cause was reported as approximately 214 days for the roflumilast group and approximately 208 days for the placebo group — though it is important to note this figure reflects a time-point within the study period, not overall survival. A blood marker of inflammation called C-reactive protein showed a reported change of 1.05 in the roflumilast group and 1.10 in the placebo group (measured on a mathematical scale). Breathlessness, measured using a questionnaire called the Transition Dyspnea Index (scored from −9 to +9, where higher scores suggest greater improvement), was reported as 0.66 for roflumilast and 0.43 for placebo. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View full results on ClinicalTrials.gov ↗ · Read the linked publication on PubMed (PMID 19716960) ↗
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 3 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 have been diagnosed with COPD (chronic obstructive pulmonary disease) and have had at least one flare-up (worsening of symptoms) in the past year
- Your breathing test results show a specific pattern of airflow limitation, with a ratio of two measurements (FEV1/FVC) at 70% or below, taken after using a bronchodilator (airway-opening medication)
- Another breathing test result (FEV1) shows your lung function is at 50% or less of what would normally be expected for someone of your age and size, taken after using a bronchodilator
Who may not be able to join:
- You are currently experiencing a COPD flare-up that has not yet cleared up by the time of your first study visit
- You have also been diagnosed with asthma or another significant lung condition
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.
Contact this trial
Principal Investigator: AstraZeneca AstraZeneca, AstraZeneca
Australian sites
Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.
GP referral letter
Print a one-page summary to share with your doctor.
Trial details
Where this trial is recruiting
11 site(s) in Australia. Confirm current status and contact details directly with the trial site.
Primary endpoints
Pre-bronchodilator Forced Expiratory Volume in First Second (FEV1); COPD Exacerbation Rate (Moderate or Severe)
Can't join this trial?
Data last synced from ClinicalTrials.gov: 26 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.