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.

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:

Current clinical trials

  • Bronchiectasis

    PROMIS II

    A double-blind, placebo-controlled, multi-centre, clinical trial to investigate the efficacy and safety of 12 months of therapy with inhaled colistimethate sodium in the treatment of subjects with non-cystic fibrosis bronchiectasis chronically infected with pseudomonas aeruginosa (p. Aeruginosa).

    Inclusion criteria 

    Subjects are eligible if they:

    1. are able and willing to give informed consent following a detailed explanation of participation in the protocol and signed consent obtained;
    2. are aged 18 years or older of either gender;
    3. are diagnosed with NCFB by computerised tomography (CT) or high-resolution CT (HRCT) as recorded in the subject’s notes and this is their predominant condition being treated;
    4. had at least 2 NCFB pulmonary exacerbations requiring oral or inhaled antibiotics or 1 NCFB pulmonary exacerbation requiring intravenous antibiotics in the 12 months preceding the Screening Visit (Visit 1) and had no NCFB pulmonary exacerbation with or without treatment during the period between Visit 1 and Visit 2;
    5. have a documented history of P.aeruginosa infection;
    6. are clinically stable and have not required a change in pulmonary treatment for at least 30 days before the Screening Visit (Visit 1);
    7.  have pre-bronchodilator FEV1 ≥25% of predicted;8. had a positive sputum culture for P. aeruginosa from an adequate sample taken at the Screening Visit (Visit 1) or during the screening period.

    Exclusion criteria

    Subjects are not eligible if they have/are:

    1. known bronchiectasis as a consequence of cystic fibrosis (CF);
    2. known history of hypogammaglobulinaemia requiring treatment with immunoglobulin, unless fully replaced and considered immuno-competent by the Investigator;
    3. myasthenia gravis or porphyria;
    4. severe cardiovascular disease such as severe uncontrolled hypertension, ischaemic heart disease or cardiac arrhythmia and any other conditions that would confound the evaluation of safety, in the opinion of the Investigator;
    5. had major surgery in the 3 months prior to the Screening Visit (Visit 1) or planned inpatient major surgery during the study period;
    6. receiving treatment for allergic bronchopulmonary aspergillosis (ABPA);
    7. had massive haemoptysis (greater than or equal to 300 mL or requiring blood transfusion) in the preceding 4 weeks before the Screening Visit (Visit 1) or between Visit 1 and Visit 2;
    8. respiratory failure that would compromise patient safety or confound the evaluation of safety or efficacy of the study in the opinion of the Investigator;
    9. current active malignancy, except for basal cell carcinoma or squamous cell carcinoma of the skin without metastases;
    10. taking immunosuppressive medications (such as azathioprine, cyclosporine, tacrolimus, sirolimus, mycophenolate, rituximab),and/or anti-cytokine medications (such as anti-IL-6 and anti-tumour alpha necrosis factor products) in the preceding year before the Screening Visit (Visit 1);
    11. known history of human immunodeficiency virus (HIV);
    12. current treatment for non-tuberculous mycobacterial (NTM) lung disease or tuberculosis;
    13. known or suspected to be allergic or unable to tolerate colistimethate sodium (intravenous or inhaled) or other polymixins, includingevidence of bronchial hyper-reactivity following inhaled colistimethate sodium;
    14. treatment with long term (≥ 30 days) prednisone at a dose of greater than 15 mg a day (or equivalent dose of any other corticosteroid) within six months of the Screening Visit (Visit 1);
    15. new maintenance treatment with any oral macrolides (e.g. azithromycin/erythromycin/clarithromycin) started within 30 days of the Screening Visit (Visit 1) or started between Visit 1 and Visit 2;
    16. use of any intravenous or intramuscular or oral or inhaled anti-pseudomonal antibiotic (except chronic macrolides with a stable dose) within 30 days prior to the Screening Visit (Visit 1) and between Visit 1 and Visit 2;
    17. pregnant or breast-feeding or plan to become pregnant over the next year or of child-bearing potential and unwilling to use a reliable method of contraception for at least one month before randomisation and throughout their involvement in the trial;
    18. significant abnormality in clinical evaluations and/or laboratory tests (physical examination, vital signs, haematology, clinical chemistry, clinically relevant impaired renal function, defined as serum creatinine levels >2.0x upper limit of normal, ECG) endangering the safe participation of the patient in the study at the Screening Visit (Visit 1) and during the study;
    19. participated in another investigational, interventional trial within 30 days prior to the Screening Visit (Visit 1);
    20. in the opinion of the Investigator not suitable for inclusion for whatever reason.

    Click here for more information.

  • Chronic Obstructive Pulmonary Disease

    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

  • Bushfire

    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.