imPACT – July 2023
Message from the Chair
Welcome to the July issue of imPACT for 2023, the official newsletter of the Pulmonary Fibrosis Australasian Clinical Trials (PACT) network. In each edition, we provide an update on clinical trial activity in interstitial lung disease, publicise relevant research grants, and highlight other events of interest.
One of the primary aims of PACT is to increase clinical trial accessibility for people with Interstitial Lung Disease (ILD). One of the methods we use to help achieve this is our website, which apart from being an important general resource for patients, researchers/clinicians and sponsors, provides a list of currently recruiting trials for ILD within the Australasian region. The list of current trials can be accessed and bookmarked here. For each study listed on the website, a study synopsis is provided summarising the inclusion and exclusion criteria as well as listing study sites.
Currently, we have eight clinical trials listed as actively recruiting, with six trials for patients with idiopathic pulmonary fibrosis, five for those with fibrotic ILD and one for those with silicosis. Five of these trials are investigator-driven, whilst three are sponsored pharmaceutical studies. An important point to note is that all studies are based at hospitals or clinics in large metropolitan centres, highlighting the need to develop methods of bringing trials to patients with difficulty accessing those sites.
Many of you may have been involved in recruiting patients for the FIBRONEER-IPF study. This study recruited at a far greater rate than anticipated and has closed recruitment, highlighting the demand for such studies globally. Patients can still be recruited to its sister study, FIBRONEER-ILD, focused on non-IPF progressive fibrotic interstitial lung disease.
I hope each of you had the opportunity for a mid-year break. I hope you find this edition of imPACT useful.
Best wishes,
Associate Professor Ian Glaspole
PACT Chair
Message from the CRE-PF
Having only commenced in March, we have hit the ground running with progress well underway in terms of planning, priorities and enhancing collaborations across all projects that form the Centre of Research Excellence in Pulmonary Fibrosis (CRE-PF) Program.
In this issue of imPACT, we continue to introduce and highlight the work of the newest members of our CRE-PF investigator team. This week, we would like to introduce A/Prof Natasha Smallwood. A/Prof Smallwood is the Head of the Chronic Respiratory Disease laboratory and Respiratory Research Training Lead at Monash University and leads a Breathlessness and Advanced Respiratory Disease Clinic at the Alfred Hospital in Melbourne.
A/Prof Smallwood’s research focuses on understanding how people experience symptoms like breathlessness, or psychological distress associated with severe lung disease. This enables her team to investigate and test new treatments, management approaches or models of care to address symptoms and provide holistic, patient-centred care.
One of the aims of the new CRE-PF is to transform the diagnosis and management of interstitial lung disease through individualised care for better patient outcomes. A/Prof Smallwood’s research will contribute to this by helping to generate robust evidence for new treatments to improve symptoms and quality of life through clinical trials of oxygen therapy and supportive care as well as providing the building blocks for future trials addressing self-management and palliative care.
I look forward to sharing some exciting updates and highlighting research developments in coming issues.
Yours sincerely,
Prof Tamera Corte (CIA for CRE-PF)
Trials Update
Australasia continues to be at the forefront of pulmonary fibrosis clinical trials. There are many early and late phase interventional studies currently in the pipeline as well as large pharmaceutically sponsored interventional studies focused on IPF on the near horizon. We will update our website as soon as study information comes to hand. Sponsors and researchers wishing to list their studies on the website can contact the pact coordinator via pactcoordinator@cre-pf.org.au or submit an online form here. Below is an update of the newest clinical trials to be listed on our website as well as reported trial results.
The latest clinical trial to be featured on the PACT website is Boehringer Ingelheim 1305-0023, a trial that will evaluate the efficacy, safety, and tolerability of the oral medication BI 1015550 9 mg and 18 mg taken twice a day compared to placebo. This study is running at 16 sites across Australia and New Zealand and is currently recruiting patients with progressive fibrosing ILDs to take the protein PDE48 inhibitor with anti-inflammatory and antifibrotic properties. The study arm recruiting patients with IPF has recently closed for recruitment. We look forward to seeing the results of this study.
In other trials news, a recent press release from a previously featured study on BMS-986278 showed twice-daily dose of 60mg of the study drug over 26 weeks resulted in a 62% relative reduction in the rate of decline in percent predicted forced vital capacity. This is wonderful news and supports the study’s progression into Phase 3.
Grants
The 2023 PACT Grant-in-Aid will open for applications in August 2023. Keep an eye on our website for application dates and the application form, which will be available soon.
The CREATE Hope Clinical Fellowship applications are now open. CREATE Fellows have been emailed further information and instructions.
Other current grant opportunities relevant to pulmonary fibrosis clinical research and trials include:
- NHMRC 2023 Clinical Studies and Cohort Studies Grants – support high-quality clinical trials and cohort studies of any size that address important gaps in knowledge, leading to relevant and implementable findings for the benefit of human health. Applications close 28th August 2023.
- MRFF 2023 International Clinical Trial Collaborations Grants – support projects that promote Australian involvement in international collaborative investigator-initiated clinical trials research through the establishment and co-ordination of clinical trial site/s in Australia; and provide high-quality evidence of the effectiveness of novel health treatments, drugs or devices in ‘usual care’ settings, which will support a decision on whether to deliver the intervention in an Australian setting. Applications close 7 Feb 2024.
- MRFF 2023 Clinical Trials Activity – anticipated opening Quarter 3 2023.
Upcoming Events of Interest
