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 8,588 people across four treatment groups, all of whom had COPD (a lung condition). The four groups each received a different inhaled combination of medicines delivered by a pressurised inhaler: two groups received a triple combination called BGF MDI (at different doses), one group received a double combination called GFF MDI, and one group received a different double combination called BFF MDI. The trial's main focus was on measuring the rate of moderate or severe COPD flare-ups (called exacerbations — episodes where symptoms worsen significantly) over the course of the study. Between roughly 1,580 and 1,713 participants in each group completed the trial. The reported data shows that the adjusted rate of moderate or severe flare-ups per year was 1.08 for the higher-dose BGF group, 1.07 for the lower-dose BGF group, 1.42 for the GFF group, and 1.24 for the BFF group. For the secondary outcomes, the number of participants who experienced at least one moderate or severe flare-up was 1,026, 1,013, 1,056, and 1,085 across the four groups respectively (noting that the median time to a first flare-up was not reached during the study). Average daily use of a reliever inhaler (Ventolin) changed by −1.2, −1.0, −0.7, and −0.8 puffs per day from the start of the study across the four groups. The number of participants recording a meaningful improvement on a respiratory quality-of-life questionnaire (SGRQ) was 1,068, 1,024, 893, and 949. The rate of severe flare-ups was 0.13, 0.14, 0.15, and 0.16 per year across the groups. Deaths from any cause during the study were reported as 28, 39, 49, and 34 participants in each group respectively. 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 ↗
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:
- Women who cannot become pregnant, are at least 2 years past menopause, or who test negative for pregnancy at the first visit and agree to use reliable birth control throughout the study.
- People who have been formally diagnosed with COPD (a chronic lung condition) based on recognised medical guidelines.
- Current or past smokers who have smoked the equivalent of at least 10 packs of cigarettes per year over their lifetime.
- People whose lung function tests show a specific level of reduced airflow and lung capacity that meets the study's requirements (confirm exact values with trial site).
- People who have a history of COPD flare-ups (episodes where their COPD got significantly worse).
Who may not be able to join:
- People who have other serious illnesses or health conditions that, in the doctor's opinion, could put them at risk or affect the study results.
- Women who are pregnant, breastfeeding, planning to become pregnant, or not using an acceptable form of contraception.
- People who currently have a diagnosis of asthma.
- People who were hospitalised due to severe COPD symptoms within the 3 months before the first study visit.
- People whose COPD has recently flared up badly enough to need steroid tablets or antibiotics within the 6 weeks before the first study visit.
- People with a weakened immune system, serious nerve conditions affecting their airway, or other factors that could put them at a high risk of pneumonia (confirm with trial site).
- People diagnosed with a specific type of eye condition called narrow-angle glaucoma that has not been adequately treated.
- People who have had an allergic reaction to any of the types of medicines used in this trial, including certain inhaled medicines used to treat breathing conditions (confirm specific medicines with trial site).
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: Paul M Dorinsky, MD, Pearl Therapeutics
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
Adjusted Rate of Moderate or Severe Exacerbations
Can't join this trial?
Data last synced from ClinicalTrials.gov: 6 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.