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

    Phase III Clinical Trial for Patents with Chronic Obstructive Pulmonary Disease (COPD) with Type 2 inflammation

    This study has the objective to investigate the efficacy and safety of dupilumab over one year in patients with COPD with Type 2 inflammation who are in need of an additional drug added to their current treatment. All patients will receive standard of care background medication throughout the study, meaning that patients can keep taking their current treatment with LABA, LAMA and inhaled corticosteroids. The proposed study provides the opportunity to assess the efficacy of dupilumab on multiple COPD domains including lung function, prevention of moderate and severe exacerbations, and symptom control.

    Inclusion criteria 

    Aged between 40 and 80 years Physician diagnosis of COPD who meet the following:

    • Current or former smoker including e‐cigarettes or vape
    • Moderate or severe COPD
    • History of signs and symptoms of chronic bronchitis (chronic productive cough) for three months
    • History of COPD exacerbation that required ICS/LAMA/LABA, antibiotics or hospitalisation in the last year
    • Background triple therapy (ICS + LABA + LAMA) or Double therapy (LABA + LAMA)

    Exclusion criteria

    • COPD diagnosis less than 12 months prior to study start
    • Evidence of right cardiac failure
    • Treatment with oxygen > 12 hours per day
    • History of or planned pneumonectomy or lung volume reduction surgery
    • Diagnosis of Alpha-1 Antitrypsin Deficiency
    • Female patients who are pregnant or are breastfeeding
    • History of HIV infection
    • Patients with active autoimmune disease or
    • Patients using immunosuppressive therapy for autoimmune disease

    Site locations 

    • Western Australia
    • Victoria

    The study will stop recruiting in July 2022.

    To see if you may be eligible to participate, a pre-screening questionnaire is available via the free call number (1800 041 548) or via a web form.

    If successful you will be provided contact details of the participating site closest to you.

    Optimising Maintenance Therapy in COPD Patients. Realworld observational study of peak inspiratory flow rate, inhalation technique and medication adherence

    This research will explore the relationship between peak inspiratory flow rate (PIFR), inhaler technique and COPD quality of life, exacerbations and medication adherence. Peak inspiratory flow rate (PIFR) has not been considered before, yet a minimal PIFR is required for dry powder devices to be used optimally (unique value for each device type) and deliver medicines to the lungs. The clinical significance of this research is that our understanding of the importance of considering PIFR when prescribing/choosing advice for maintenance therapy and its impact on clinical outcomes and health related quality of life of people with COPD.

    Inclusion criteria 

    • People living with COPD
    • Over 40 years old
    • Using dry powder inhalers for maintenance therapy for COPD for more than three months.

    Exclusion criteria

    • People with COPD that have had an exacerbation in the past 6 weeks.
    • People participating in another COPD related research project.
    • People with a short life expectancy.

    For information on participating centres, please contact the study coordinator Phone: 02 9114 0479 Email: woolcock.respimedicines@sydney.edu.au.

    Click here to visit the trial website for further information.

    The Multi-Care Study: Empowering carers of people with multimorbidity as partners in chronic disease care

    Informal family carers (a patient’s partner, family member, or friend) play a critical role in patient care. They commonly attend medical consultations and liaise with health professionals, provide emotional and informational support to patients, assist in treatment decision-making , support treatment adherence, provide home-based care including helping manage medications, symptoms, and side-effects, and can facilitate healthy lifestyle behaviours. However, reflecting their generally overlooked and under-supported position, carers tend to have greater unmet informational and psychosocial needs than patients themselves, as well as experiencing negative impacts on their physical health and quality of life . Research into facilitating optimal involvement of carers is increasing, however, it has typically focused on carers of individuals with a single-disease, most commonly cancer. A population of patients and carers that is beginning to receive increasing recognition as a growing challenge for health professionals and significant public health concern is individuals with multimorbidity.

    This project aims to explore the experiences and needs of carers of people with multimorbidity through qualitative interviews with stakeholders (carers, patients, health professionals).

    Inclusion criteria 

    Patients with multimorbidity i.e. are diagnosed with two or more of the most common chronic health conditions (including cardiovascular disease, diabetes, chronic obstructive pulmonary disease, kidney disorders, cancers, arthritis, anddepression). To be eligible, patient participants must have a family/friend carer involved in their ongoing health condition management.

    Carers of patients with multimorbidity will be recruited separately to patient participants. Linked patients and carers do not both have to participate in the study, i.e. carers can participate without the patient’s participation. A carer of a deceased person who had multiple chronic health conditions is also eligible to participate.

    ‘Carers’ can be any family member or friend who attends medical consultations and assists the patient with their illness.

    Exclusion criteria 

    Patient participants will be excluded if they are:

    • Receiving end of life care
    • Unable to provide informed consent due to insufficient English language, being under the age of 18, or having cognitive functioning limitations.
    • Carer participants will be excluded if they are unable to provide informed consent due to insufficient English language, being under the age of 18, or having cognitive functioning limitations.

    If you are interested in participating in this study, please contact Dr Rebekah Laidsaar-Powell atrebekah.laidsaar-powell@sydney.edu.au or on 0402 656 720.

  • 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. 

  • Primary Ciliary Dyskinesia

    REPEAT Study | Improving outcomes of children and young adults with primary ciliary dyskinesia

    A multi-centre, double-blind, double-dummy, 2×2 partial factorial, randomised controlled trial.

    Professor Anne Chang and the group of investigators are looking for people with PCD to consider taking part in the REPEAT study.
    The aim of the REPEAT study is to determine if improvements can be made to the health and/or quality of life of people with PCD (or suspected PCD) by taking erdosteine (mucolytic) and Azithromycin. We are also exploring a new way to diagnose PCD through a saliva sample.
    This clinical study is an Australia-wide collaborative project with the main recruiting hospitals located in Brisbane, Sydney, Melbourne, Darwin and Perth. The REPEAT Study team work in collaboration with the treating doctor where patients are not attending the recruiting hospital. We offer ‘remote’ participating options for people who are interested in participating but do not live close to these hospitals.
    Eligibility criteria
    Children and adults aged 2-65 years who:
    • Have a diagnosis of PCD (e recognise that PCD diagnosis is complex so are enrolling people to the study either with a proven diagnosis or a “suspected PCD” diagnosis based on their presenting picture.)
    • Have had at least 2 exacerbations (flare ups) in the last 18 months.

    Expectation on participants

    • Ability to provide informed consent (e-consent available)
    • Take two medications for the 12-month period (unless azithromycin, is already prescribed, then only one)
    • Complete monthly survey via online survey links
    • Saliva sample and nasal swabs when possible
    If you have any patients that may be interested in taking part in the study, please contact Project Manager Anne Cook (07) 3069 7283 or email kidslungresearch@qut.edu.au for more detailed information.
    Click here to view the trial website for more information.
  • Nontuberculous Mycobacterial (NTM) Lung Disease

    Arise

    Validation of Patient Reported Outcome Measures in Participants With Nontuberculous Mycobacterial Lung Infection Caused by Mycobacterium Avium Complex (ARISE)
    Study to Evaluate ALIS (Amikacin Liposome Inhalation Suspension) in Participants With Nontuberculous Mycobacterial Lung Infection Caused by Mycobacterium Avium Complex (ENCORE)

    A clinical study for people with nontuberculous mycobacterial (NTM) lung infections caused by Mycobacterium avium complex (MAC).

    Inclusion Criteria:

    • Male or female, ≥ 18 years of age
    • Current diagnosis of MAC lung infection. MAC or mixed infection with MAC as the dominant species is allowed, with MAC as the intended organism for treatment.
    • A chest computerized tomography (CT) scan, read locally, within 6 months prior to Screening to determine presence and size of pulmonary cavities. Participants who do not have a chest CT scan within 6 months prior to Screening will be required to obtain a chest CT scan, read locally, during Screening.

    Exclusion Criteria:

    • Diagnosis of cystic fibrosis (CF).
    • History of more than 3 MAC lung infections.
    • Received any mycobacterial antibiotic treatment for current MAC lung infection.
    • Refractory MAC lung infection, defined as having positive MAC cultures while being treated with a multidrug mycobacterial antibiotic treatment regimen for a minimum of 6 consecutive months and no documented successful treatment, defined as negative sputum culture for MAC and cessation of treatment.
    • Relapse of prior MAC lung infection, defined as positive sputum culture for MAC ≤6 months of cessation of prior successful treatment.

    For more information or to apply for this study please 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.

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