Chronic Obstructive Pulmonary Disease (COPD) is a progressive lung condition that causes breathing difficulties, a persistent cough, and reduced quality of life. It is most commonly caused by long-term smoking, though many people remain undiagnosed for years.
COPD affects an estimated 1 in 13 Australians over the age of 40. It is a leading cause of potentially preventable hospitalisations, yet around 50% of people living with the condition may not know they have it.
In 2023–24, Australia spent an estimated $1.8 billion managing COPD, accounting for 30% of all respiratory condition expenditure.
For people living with both COPD and high cardiovascular risk, the health burden is compounded. COPD places additional strain on the heart, and conditions like diabetes, high cholesterol, and heart disease can make managing COPD more challenging. This trial is evaluating a new investigational inhaler-based treatment to assess whether it can improve outcomes for this group, comparing a triple-therapy inhaler against a double-therapy inhaler, with all participants receiving an active treatment.
Unlike many trials, all participants receive an active treatment, there is no placebo. Participants are randomly assigned to either a triple or double inhaler therapy, both administered twice daily, giving everyone a meaningful chance of benefit.
treatment design
All eligible participants will be randomly assigned to receive either a triple or double inhaler therapy, each administered twice daily via inhaler, with a 50% chance of receiving either. There is no placebo in this trial. Participants will attend 8 clinic visits over 3 years at our Birtinya clinic, approximately every 3 months in the first year, then every 6 months for the following 2 years. All trial-related treatment is provided at no cost to participants.
