phase II
enrolling now

The Moderate to Severe COPD Trial

For current or former smokers aged 40–80 with a diagnosis of moderate to severe COPD who have been on stable daily COPD treatment for at least 3 months. Conducted at our Vitality Village clinic in Birtinya on the Sunshine Coast.
Age 40-80
day visits
Up to $3450
About this trial

A potential new injection treatment for people living with moderate to severe COPD

Chronic obstructive pulmonary disease (COPD) is a progressive lung condition that causes the airways to narrow over time, making breathing increasingly difficult. It is a chronic disease, meaning there is currently no cure, but with the right treatments, many people with COPD continue to live long and fulfilling lives. Symptoms can be mild in the early stages and are sometimes mistaken for asthma, low fitness, or simply getting older. When symptoms do appear, they may include shortness of breath, recurring cough, phlegm or mucus, fatigue, and more frequent chest infections with longer recovery times.

COPD is the fifth leading cause of death and disease burden in Australia. About 1 in 13 people over the age of 40 are thought to have COPD, yet around 50% may not know they have it. In 2022, an estimated 496,000 Australians aged 45 and over were living with COPD, and in 2023–24 there were 69,200 hospitalisations where COPD was the principal diagnosis. Despite existing treatments helping to manage symptoms, there remains a continued need for more effective, safe, and accessible therapeutic options.

This trial is evaluating a new investigational treatment delivered by injection under the skin that may help improve outcomes for people living with moderate to severe COPD, offering a potential new option for those whose condition is not fully controlled by current therapies.
There is a 50% chance of receiving the investigational treatment rather than a placebo. Participants will also wear an Oura ring throughout the study, a wearable device that monitors sleep and activity levels, giving the research team valuable real-world health data between clinic visits.
Eligibility

Do you qualify?

Aged 40-80
Diagnosed with moderate to severe COPD for at least the last 12 months
Currently on stable daily COPD treatment for at least 3 months (medium or high dose ICS and LABA and/or LAMA)
Current or former smoker with at least 10 pack-years of smoking history (not sure of your pack-years? Calculate here)
Non-smoker or vaper (e-cigarettes), unfortunately not eligible for this trial
What's involved

Commitment and procedures

Visit type
day visits
total visits
15
duration
40 weeks
treatment
Subcutaneous Injection

procedures

ECG (electrocardiogram)
Blood and urine sample collection
Vital signs and physical examination
Sputum sample collection
CT scan (2 scans over the study period)
Oxygen saturation check (via pulse oximetry)
Spirometry and other respiratory tests
Subcutaneous injection (investigational treatment or placebo)
Questionnaires
Impulse oscillometry (IOS)

treatment design

Eligible participants will be randomly assigned to receive either the investigational treatment or a placebo, administered by injection under the skin, with a 50% chance of receiving either. Participants will attend up to 15 clinic visits at our Vitality Village clinic in Birtinya over 40 weeks. Two CT scans will be performed over the course of the study, alongside regular spirometry and respiratory function tests to monitor lung health. 

Participants will also wear an Oura ring throughout the study, a comfortable wearable device that tracks sleep and activity in real time, helping the research team build a fuller picture of each participant's health between clinic visits. All procedures will be explained clearly, and participants can ask questions at any time.
More information

Have questions? We're here to help.

Contact our recruitment team directly; they're happy to answer any questions before you apply to the moderate to severe COPD trial. Please do not send personal medical information by email.
Phone
+07 5409 8640
Hours
Mon–Fri, 8am–5pm
Trial at a glance
Status
enrolling
Phase
phase II
Therapeutic Area
Ages
40-80
Duration
40 weeks
Visits
15 visits
Location
Birtinya clinic
PROTOCOL
PRA-216-201-COPD
Remuneration
Up to $3450

Ready to check your eligibility?

Takes ~1 minute to enrol in our moderate to severe COPD trial.
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This trial has been reviewed by an independent human research ethics committee.

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