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 629 people with a breathing condition (316 in one group and 313 in the other). Participants were assigned to receive either an inhaled combination medicine called QMF149 or a comparator combination inhaler called Salmeterol Xinafoate/Fluticasone Propionate (a commonly used treatment for conditions like asthma or COPD). The trial ran for approximately 12 weeks (85 days) and its main focus was on measuring lung function using a breathing test called FEV1 — this measures how much air a person can forcefully breathe out in one second, recorded in litres. A higher number generally indicates more air being exhaled. By the end of the trial, 299 people in the QMF149 group and 288 in the comparator group had completed it. The reported data shows that the primary outcome — a lung function reading taken roughly 23–24 hours after a dose on Day 85 (called "trough FEV1", meaning the measurement at the point when the medicine's effect would be at its lowest) — was approximately 1.27 litres for the QMF149 group and approximately 1.22 litres for the comparator group. For the secondary outcomes, lung function readings taken at various earlier time points (including after the first dose and after four weeks) were also reported, with values ranging roughly between 1.14 and 1.29 litres across both groups and time points. Additional breathing measurements (FVC, which measures total air breathed out, and the ratio of FEV1 to FVC) were also recorded at multiple points; the reported data shows these figures were broadly similar between the two groups across the timepoints measured. 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 2 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 moderate to very severe COPD (a lung condition that makes it hard to breathe), based on recognised international guidelines.
- Breathing tests done after using a bronchodilator (an inhaler that opens the airways) show your lung function is below certain levels, confirming the severity of your COPD.
- You are a current smoker or ex-smoker with at least 10 "pack years" of smoking history — for example, smoking one pack of cigarettes a day for 10 years, or half a pack a day for 20 years.
- If you are an ex-smoker, you must have stopped smoking for at least 6 months before the screening visit.
Who may not be able to join:
- You have had a COPD flare-up (worsening of symptoms) in the last 6 weeks that needed antibiotics, steroid tablets, or a hospital stay.
- You have a COPD flare-up between your first screening appointment and the start of treatment, though you may be able to re-apply at least 6 weeks after fully recovering.
- You have had a chest or respiratory infection (such as a cold affecting your lungs) within the 4 weeks before your screening appointment.
- You develop a respiratory infection between your screening appointment and the start of treatment, though you may be able to re-apply 4 weeks after fully recovering.
- You need to use oxygen at home for more than 12 hours per day.
- You have ever been diagnosed with asthma, or your breathing problems started before you were 40 years old.
- There may be additional eligibility requirements not listed here (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: Novartis Pharmaceuticals, Novartis Pharmaceuticals
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
Mixed Model for Repeated Measures (MMRM): Between-treatment Comparisons for Trough FEV1 (L) on Day 85
Can't join this trial?
Data last synced from ClinicalTrials.gov: 16 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.