Research Center: TrialsWest Osborne Park
Location: 226 Main Street, Osborne Park, 6017 Australia
Lead Researcher: Professor Peter Bremner
HREC: This study has been reviewed and approved by the Monash HREC

Breathing shouldn’t feel like a daily struggle, but for many people with COPD, it does. Flare-ups can happen without warning, making it harder to stay active and enjoy life. Each flare-up doesn’t just take away energy in the moment; it can affect independence over time.

This study is looking at AZD6793, a tablet that may help by reducing inflammation in the lungs, which is a big part of COPD. Researchers want to see if it can reduce the number of flare-ups, make breathing easier, and offer safer options for the future. Participants will also receive careful monitoring and support from medical professionals.

Could this study be a step toward easier breathing and a better life with COPD? Answer a few questions to see if you may qualify.

• Get a chance to try a new tablet being studied for COPD (3 in 4 participants will receive it).
• Even if placed in the placebo group, you’ll keep taking your regular COPD treatments; your current care won’t change.
• Receive regular health check-ups and support from medical professionals throughout the study.
• Play a role in helping researchers discover if this new treatment can reduce flare-ups and make breathing easier.
• Be compensated for your time and participation.
• Contribute to research that may lead to safer, more effective COPD treatments in the future.
• Join a study that values your experience and health, while contributing to future treatments

You will receive a detailed outline of all details of the study, including treatment, risks, and procedures, and you will be given the chance to ask study staff questions before you decide whether to participate.
If you decide to participate in the study and later feel that you no longer wish to be part of it, you can withdraw at any time
Your records relating to this study and any other information received will be kept strictly confidential, except as required by the law.

Eligible:

• Men and women aged 40 or older who have been diagnosed with COPD for at least 1 year.
• Have had at least 1 flare-up of your COPD in the last year that required you to take oral steroid tablets (such as prednisolone), antibiotics or be hospitalised for treatment
• Have been using inhalers containing 2 or 3 different medicines to treat COPD for at least 3 months (such as Trelegy, Enerzair, Trimbow, Breztri, Ultibro, Anoro, Spiolto, Brimica, Symbicort, Breo, or Fostair).
• Are a current or former smoker with a history of at least 10 pack-years (for example, smoking 1 pack a day for 10 years).
• Must be able to attend 9 study visits at the research site over approximately 6 months

Ineligible:

• Has another serious lung condition, such as:
  • Asthma (airways swell and make breathing difficult)
  • Pulmonary fibrosis (scarring of the lungs)
  • Cystic fibrosis (a genetic condition that causes thick mucus in the lungs)
  • Bronchiectasis (damaged airways that trap mucus)
  • Lung cancer
• Has certain serious heart problems, such as:
  • Severe heart failure
  • Recent heart attack
  • Uncontrolled irregular heartbeat (arrhythmia)
  • Severe valve disease
• Need more than 4 liters of oxygen per minute (unless oxygen levels stay at or above 89% while walking).
  • Has any of the following medical conditions:
  • Immune system problems
  • Inflammatory bowel disease
  • Ongoing liver problems (like hepatitis B, untreated hepatitis C, or chronic liver disease)
  • HIV infection
• Is pregnant, planning pregnancy, or planning to donate sperm/eggs during the study or within 2 weeks after.

TrialsWest
Established in 2012, TrialsWest is one of Australia’s most experienced and successful clinical research centres. TrialsWest, with locations in Spearwood, Osborne Park and Mandurah in Perth, Western Australia, partners with the world’s leading pharmaceutical and biotechnology companies to help bring new medicines and vaccines to the world.