Clinical Trials Unit
Before any drug is made available to the public, manufacturers are required to ensure that it is safe to do so by undertaking clinical trials. Our clinical trials unit is one of the largest of its kind in Australia and is highly regarded, nationally and internationally, for its work in helping pharmaceutical companies test the safety and efficacy of drugs used to treat chronic lung disease.
The Unit undertakes clinical trials for respiratory conditions including asthma, COPD, alpha 1-antitrypsin deficiency, bronchiectasis, idiopathic pulmonary fibrosis (IPF) and cystic fibrosis. We also had experience in a healthy volunteer vaccine trial in 2019.
It has a reputation for providing precise quality data and adding value to trials through intelligent delivery. The Unit has been operating for all of the Institute’s 20 years and has an international reputation. The site is regularly in the top two recruiters globally for their clinical trials and has an outstanding record when it comes to expediting the setting up of each trial. We have participated in many sponsor and Ethics Committee initiated audits with no critical findings.
Each year our Clinical Trials Unit conducts around 20 clinical trials for chronic respiratory conditions which are sponsored by a range of Australian and international pharmaceutical and biotech companies. In addition to the extensive range of sponsored clinical studies, the Unit plays a pivotal role in supporting research being undertaken by other divisions within the Institute.
The Unit sees approximately 200 West Australians a year as part of their ongoing clinical trials and a large proportion of these have complex lung disease. Through regular contact with the respiratory physicians and nurses in the Unit, patients receive education about their disease and managing their condition in conjunction with their other comorbidities. The patients almost universally express their appreciation of the friendly, helpful and supportive care they receive from the staff.
The Unit makes a significant contribution to the State’s economy. It attracts, on average, almost $700,000 of contracted medical research to Western Australia each year. As a not-for-profit organisation, all profits are directed back into the Institute and are used to support further respiratory research activity here in Western Australia.
Several medications now commonly used in the community have been trialled within the Unit, including:
- In 2000 – Seretide (GSK) – For the regular treatment of asthma, where the use of a combination product is appropriate
- In 2002 – Symbicort (AstraZanica) – Symbicort is indicated for the symptomatic treatment of moderate to severe COPD (FEV1 ≤50% predicted normal) in adults with frequent symptoms despite long-acting bronchodilator use, and/or a history of recurrent exacerbations
- In 2002 – Spiriva (Boehringer ingelheim) – Spiriva is used to make breathing easier for people with chronic obstructive pulmonary disease (COPD)
- In 2003 – Xolair (Novartis) – Xolair is a recombinant DNA-derived humanised monoclonal antibody that selectively binds to human immunoglobulin E (IgE)
- In 2004 – Alvesco (AstraZenica) – ALVESCO is indicated as prophylactic treatment of asthma in adults, adolescents and in children 6 years of age and older
- In 2013 – Kalydeco (Vertex) – used to treat cystic fibrosis patients with the F508del/G551D. Kalydeco helps to improve breathing, exacerbations, and improve weight gain
- In 2014 – Ultibro Breezehaler (Novartis) – a once-daily maintenance bronchodilator treatment to relieve symptoms in patients with COPD, and for the reduction of exacerbations of COPD in patients with a history of exacerbations
- In 2017 – Mepolizumab (GSK) – Used to treat Severe Asthmatics with Eosinophils
- In 2016 – Prolastin C (Grifols – trials ongoing) – Alpha-1-proteinase inhibitor (Alpha1-PI) to treat alpha 1 antitrypsin deficiency
- In 2018 – Benralizumab (AstraZenica) –used to treat servere esophilic asthmatics and is a monoclonal antibody which works on the alpha-chain of the interleukin-5 receptor
- In 2018 – Okambi (Vertex) – used to treat cystic fibrosis with F508del/F508del. Okambi helps to improve breathing, reduce the risk of lung infections, and improve weight gain
- In 2018 – Trelegy Ellipta (GSK) – the first once-daily single inhaler triple therapy for the treatment of appropriate patients with COPD
- In 2019 – Symdeco (Vertex) – used to treat cystic fibrosis with F508del/F508del. Okambi helps to improve breathing, reduce the risk of lung infections, and improve weight gain
To contact the Clinical Trials Unit please phone 6151 0888 or email email@example.com.
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A Perth clinical trial may give you access to new, innovative treatments. People who take part in a trial are often the first to access and benefit from new and emerging treatments.