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 (NCT01854645) enrolled 2,103 people across five groups to study the effects of different inhaled medicines on lung function in people with COPD (a chronic lung condition). The five groups were: GFF MDI (527 people), GP MDI (451 people), FF MDI (452 people), Spiriva® Handihaler® (453 people), and a placebo — an inactive treatment — (220 people). The main thing being measured was a change in lung function, specifically a breathing test called FEV1 (how much air a person can forcefully breathe out in one second), taken in the morning before any medication dose, after 24 weeks. The reported data shows that at 24 weeks, every group except the placebo group showed an increase in their morning FEV1 from where they started. The GFF MDI group's average result increased by 0.126 litres, the Spiriva® Handihaler® group by 0.105 litres, the GP MDI group by 0.066 litres, and the FF MDI group by 0.062 litres. The placebo group's average result decreased slightly by 0.024 litres. A secondary measure — looking at average lung function across the full 24 weeks — showed a similar pattern, with the GFF MDI group reporting the largest average increase of 0.150 litres. The reported data also shows that scores on a quality-of-life questionnaire (where lower scores mean better health status) decreased across all groups, with the GFF MDI group showing the largest reported change of -3.1 points. Additionally, the average number of puffs of rescue medication used per day decreased in all groups except the placebo group, which showed a small increase. 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 35815359) ↗
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 are between 40 and 80 years old
- You have been diagnosed with COPD (a long-term lung condition) based on recognised medical guidelines
- You are a current or former smoker with at least a 10 pack-year smoking history (for example, smoking one pack a day for 10 years, or two packs a day for 5 years)
- Your lung function test (a breathing test called an FEV1) shows your lungs are working at less than 80% of what would be expected for someone your age and size
- You are willing and able to make changes to your current COPD medications as required by the study, in the opinion of the study doctor
Who may not be able to join:
- You have another serious illness or condition that, in the study doctor's opinion, could put you at risk or affect the study results
- You currently have a diagnosis of asthma or a condition called alpha-1 antitrypsin deficiency
- You have another active lung disease, such as active tuberculosis, lung cancer, bronchiectasis, sarcoidosis, pulmonary fibrosis, pulmonary hypertension, or uncontrolled sleep apnea
- You were hospitalised due to a severe COPD episode within the 3 months before or during the screening period
- Your COPD has been poorly controlled recently, needing steroid tablets or antibiotics within the past 6 weeks before or during the screening period
- You had a lower respiratory tract infection requiring antibiotics within the past 6 weeks before or during the screening period
- You have unstable heart disease, poor heart pumping function, or had a heart attack within the past 12 months
- You have had a recent heart procedure or bypass surgery within the past 3 months
- You have moderate to severe heart failure (confirm with trial site)
- You have a clinically significant abnormal heart tracing (ECG)
- Your liver function blood tests are significantly above normal levels
- You have had cancer that has not been fully in remission for at least 5 years
- You have a known allergy or sensitivity to certain types of inhaled medicines used in this trial, including beta-agonists, anticholinergics, lactose, milk protein, or related ingredients (confirm 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: Colin Reisner, MD, Pearl Therapeutics, Inc.
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
12 site(s) in Australia. Confirm current status and contact details directly with the trial site.
Primary endpoints
Change From Baseline in Morning Pre-dose Trough FEV1 at Week 24
Can't join this trial?
Data last synced from ClinicalTrials.gov: 21 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.