Clinical Research

Clinical research studies, such as clinical trials, are ways of testing how well treatments work and how safe they are. They play a key role in driving discoveries for new treatment, managing conditions and searching for a cure.

Clinical trials are usually developed to observe the effect of new treatments or new ways of using known treatments on humans – such as comb treatments. Before a new drug treatment can be made available widely, it will need to pass several stages of testing – this is where trials come in.

When a new treatment is undergoing a clinical trial, large numbers of people may be required to participate to produce meaningful results. A clinical trial may involve people both in Australia and overseas.

Current clinical trials

Lung Foundation Australia collaborates with a number of organisations to facilitate participation in the development, conduct, evaluation and reporting of clinical trials in lung disease.  These include:

Preventing Adverse Cardiac Events in Chronic Obstructive Pulmonary Disease

Heart disease is very common in people diagnosed with COPD and is often the cause of health-related sickness and hospitalisations. COPD and heart disease often have similar symptoms and it can be difficult to diagnose the difference. In this study, researchers will investigate whether long-term (two-year) drug treatment of heart disease in COPD can reduce cardiac events, such as stroke and heart attacks, occurring in the future. This is important for people with COPD with either known or unknown underlying heart disease. The study also aims to investigate whether this treatment reduces the number of episodes of worsening respiratory symptoms experienced, including the number of hospitalisations or increased medication.

Inclusion Criteria:

  1. Have provided written informed consent
  2. Have COPD defined by the 2019 Global Initiative for Chronic Obstructive Lung Disease (GOLD) diagnostic criteria
  3. Aged ≥40 and ≤85 years
  4. FEV1 ≥30% and ≤70% predicted post-bronchodilator
  5. FEV1/FVC <0.7 post-bronchodilator
  6. Have had a COPD exacerbation in the previous 24 months requiring OCS, antibiotics, or both
  7. If taking maintenance OCS, dosage is stable and ≤10 mg daily for 4 weeks prior to randomisation
  8. Resting Systolic BP (SBP) ≥100mmHg
  9. BP and spirometry criteria must be met after the test dose of bisoprolol of 1.25mg

Exclusion Criteria:

  1. Concurrent therapy with any other β-blocker
  2. Resting HR <60 beats per minute (bpm)
  3. Unstable left HF (i.e. symptomatic and/or necessary change in management in the last 12 weeks, or in investigator’s opinion)
  4. Clinically significant pulmonary hypertension, which in the investigator’s opinion would be a contra-indication for β-blocker therapy
  5. Severe end-stage peripheral vascular disease
  6. 2nd or 3rd degree heart block
  7. Currently using or have been prescribed long-term oxygen therapy (LTOT) or resting saturated oxygen level <90% when stable
  8. Expected survival is less than 12 months, or in the investigator’s opinion the person has such unstable disease (of any type) thatmaintaining 12 months’ participation would be unlikely
  9. Clinical instability since a MACE in the previous 12 weeks
  10. Lower respiratory tract infection or acute exacerbation of COPD (AECOPD) in the last 4 weeks
  11. COPD not clinically stable as determined by the investigator
  12. In the investigator’s opinion, have asthma-COPD overlap or co-existent asthma are present; or an improvement in FEV1 ≥400mLpost-bronchodilator is observed on two occasions
  13. Females of child-bearing age and capability who are pregnant or breastfeeding or those in this group not using adequate birthcontrol
  14. Coexistent illness which precludes participation in the study (e.g. poorly controlled diabetes, active malignancy)
  15. Severe end-stage liver disease defined by International Normalised Ratio (INR) >1.3 and albumin <30g/L or portalhypertension/ascites.
  16. High chance in the opinion of the investigator that the potential participant will not adhere to study requirements.

Recruitment period: 06/04/2021 to 31/12/2022

To find out more, email paceincopd@georgeinstitute.org.au

A randomised controlled trial of mask use in control of respiratory outcomes during bushfire season

There is a gap in evidence about the use of face masks, P2 masks or avoidance of outdoor air in reducing the physiological impacts of prolonged bushfire smoke exposure on exacerbations of asthma and other respiratory conditions. There is no clinical trial efficacy data to support the choice and use of facemasks, P2 masks or staying indoors for protection against bushfire smoke.

The aim of this research is to determine the impact effect of bushfire smoke exposure and of the use of surgical masks and P2 respirators on adverse respiratory outcomes during bushfire season in New South Wales, Victoria, Australian Capital Territory and South Australia.

Inclusion criteria:

  • Adults 18 years and over
  • Living in a bushfire prone area (as defined by fire services in NSW, Victoria, ACT, Tasmania and South Australia)
  • Living with asthma or COPD (emphysema, chronic bronchitis, bronchiectasis).

Exclusion criteria:

  • <18 years old
  • Facial hair – beard, moustache, stubble (due to fit of masks)

To find out more and register your interest click here. 

Get involved in a clinical trial

Lung Foundation Australia does not endorse any research study listed on this website. Participation in any trial is voluntary and it’s important you understand what is involved before you take part and are satisfied that your health and privacy will be protected. In Australia, clinical trials must follow the National Health and Medical Research Council guidelines and have approval from a registered Human Research Ethics Committee.

If you have concerns about a research project or clinical trial, you can make a complaint to the Human Research Ethics Committee that approved the study.