Clinical Research

Current clinical trials

• Lung Cancer

  MySurvivorCare Scoping Survey: Study Description

  Some women cancer survivors experience menopausal symptoms from cancer and its treatments. This experience is well documented in the breast cancer population. However, little is known about the menopausal symptoms experienced by women survivors of other cancers, including those where the treatments used are known to cause menopause. There are effective ways to help manage menopausal symptoms after cancer treatment. Therefore, we need to understand the prevalence and experience of menopausal symptoms in women cancer survivors, their methods used and unmet needs to manage these symptoms. Our study findings are expected to inform the development of strategies to help a broad range of women cancer survivors.

  This study is being conducted by the University of Melbourne, and involves researchers from the Peter MacCallum Cancer Centre, the University of Melbourne, Royal Women’s Hospital, Royal Melbourne Hospital, and King Edward Memorial Hospital.

  Study Requirements

  Participation is all online. Those who take part will need to confirm their eligibility to participate in this study, provide consent and complete one anonymous survey. The survey is expected to take ~20-25 minutes to complete.

  Participant Eligibility

  Inclusion Criteria

  • Recorded female at birth;
  • Aged 18 years or above;
  • Living in Australia;
  • Able to read and write in English;
  • Able to access the internet;
  • Received at least one cancer diagnosis, and;
  • Satisfy at least one of the following cancer treatment criteria (for first cancer diagnosis):
    • Completed chemotherapy and/or received radiotherapy, surgery, or a stem cell transplant more than six months ago;
    • Used or are using long term cancer treatment (endocrine therapy, PARP inhibitor, Immunotherapy, Bevacizumab (e.g. Avastin)).

  Exclusion Criteria
  Diagnosis of non-melanoma skin cancer (as only cancer diagnosis).

  For Further Information Please Contact:

  Ms Sherine Sandhu
  Study Coordinator
  P: 1800 925 330
  E: sherines@unimelb.edu.au

  A/Prof Michelle Peate
  Lead Investigator
  P: +61 3 8345 3792
  E: mpeate@unimelb.edu.au

• Chronic Obstructive Pulmonary Disease

  SINFONIA

  What is SINFONIA?

  SINFONIA is a randomised clinical trial of online guided group singing for people with chronic obstructive pulmonary disease or interstitial lung disease who are experiencing breathlessness. Carers of people participating in SINFONIA may also choose to participate. People participating in SINFONIA are randomly assigned to active (singing) or control (normal care) groups. Patients assigned to the control group will be given the option to attend 12-weeks of online guided group singing at the end of the trial period.

  Who can participate in SINFONIA?

  Patients aged over 18 with a confirmed diagnosis of COPD or ILD on stable treatment for at least 4 weeks (meaning no new or changed cardiorespiratory medications or hospital admissions for COPD or ILD) with breathlessness (mmrc ≥ 2) who are NOT currently participating in pulmonary rehabilitation and who are capable and willing to give informed consent are eligible to participate. Nominated carers aged over 18 years who are capable and willing to give informed consent may also participate.

  How long does SINFONIA run?

  SINFONIA runs for 12 weeks. Participants assigned to the control group will complete 12 weeks of normal care and then have the option to join the singing group for a further 12 weeks. No study assessments are collected during the second 12 week period.

  What do participants need to do?

  Participants in the singing group will need to attend a 90-minute online group singing session once a week, for 12 weeks. Participants in the control arm will continue normal care during this time. Participants will be contacted by a member of the research team at 4-weekly intervals throughout the trial and asked to complete some questionnaires about theirsymptoms and healthcare usage (4 times in total). If participants have not had a recent lung function or exercise tolerance test, they may need to attend on-site to complete these prior to the start of the trial. A member of the research team will organise these tests. Particpants may also be interviewed about their experiences with online singing classes prior to, during, or at the end of the study period. This interview will take approximately 30-60 minutes and may take place in person, over the phone, or via an online video conference.

  What is the recruitment target?

  We are aiming to recruit 60 patient participants per site over an 18 month period. This is equivalent to approximately 1 patient per site per week.

  If you are interested in participating or if you are a clinician who wants to refer a patient to the trial,  please contact The SINFONIA team’s research assistant Catherine Buchan:  c.buchan@alfred.org.au.

  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

  ENCORE

  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).

  Disease area: Nontuberculous Mycobacterial Lung Disease

  Study sponsor: Insmed

  Contact: Annette Thwaites (annette.thwaites@insmed.com)

  Title: Study to Evaluate ALIS (Amikacin Liposome Inhalation Suspension) in Participants with Nontuberculous Mycobacterial Lung Infection Caused by Mycobacterium avium Complex ENCORE

  Description: 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.

  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.

  For more information or to apply for this study please click here.