ILD & Pulmonary Fibrosis Clinical Trials
Clinical trials have driven most of the meaningful treatment advances in pulmonary fibrosis over the past decade, and remain an important option for many patients — particularly where existing treatments are limited or a disease is progressing despite standard therapy. Dr Mackintosh is Principal Investigator on a number of Phase 1–3 ILD clinical trials in Brisbane and sits on the Steering Committee of PACT, the national network coordinating pulmonary fibrosis trials across Australia and New Zealand.
What is a clinical trial?
A clinical trial is a research study that tests whether a new treatment is safe and works, after it has already shown promise in the laboratory. Every participant's response is closely monitored, and every trial is reviewed and overseen by an independent Human Research Ethics Committee to protect participants' safety and rights. Taking part is always voluntary.
Many pulmonary fibrosis trials are randomised controlled trials, meaning participants are allocated by chance to either the new treatment or a comparison group, which may receive a placebo or the current standard of care. Where a placebo arm is used, participants can usually continue any antifibrotic therapy they are already taking, with the trial treatment added on top rather than replacing it — the participant information sheet for each specific trial explains exactly how that trial is structured.
Weighing up participation
Taking part in a trial can offer earlier access to emerging treatments, more frequent monitoring by your treating team, and the chance to contribute to better options for future patients. It can also mean more frequent clinic visits, additional tests such as blood draws, and the possibility of being allocated to a placebo or comparison group. Your care team can talk through how these trade-offs apply to a specific trial you're considering.
Before agreeing to take part, you'll be given a detailed participant information and consent form to review — worth reading closely, and discussing with family, your GP or your specialist. Useful questions to ask include: whether there is a placebo arm, how long the trial runs, how often you'll need to attend appointments, what extra tests are involved, and what happens to your treatment once the trial ends.
What to expect if you take part
After providing consent, the research team will assess your eligibility based on factors such as disease stage, age and other medical conditions. If eligible, you'll undergo baseline health assessments before starting treatment, followed by regular monitoring visits during and after the trial period to track your wellbeing and any side effects. You're free to withdraw at any time, for any reason, without it affecting your ongoing care.
Trials are conducted in different formats — some fully in-person, others incorporating telehealth visits or run as teletrials with assessments completed locally — which can make participation more practical for patients outside Brisbane. See Referrals for more on telehealth access to Dr Mackintosh's practice generally.
Trials with Dr Mackintosh
Dr Mackintosh is Principal Investigator on Phase 1–3 clinical trials in idiopathic pulmonary fibrosis and progressive pulmonary fibrosis, including recent studies of nerandomilast and inhaled treprostinil, and has led the TELO-SCOPE trial of danazol for short telomere-related pulmonary fibrosis. He also contributes to lung transplant outcomes trials, including the ASSIST CLAD study. See Research & Publications for further detail on trial involvement and publications.
Find a trial near you
Current pulmonary fibrosis trial opportunities across Australia and New Zealand, including those open in Queensland, can be searched through PACT — the Pulmonary Fibrosis Australasian Clinical Trials Network.
For a plain-language overview of what clinical trials in pulmonary fibrosis involve, see the "Clinical Trials in Pulmonary Fibrosis" fact sheet, published by Lung Foundation Australia and the NHMRC Centre for Research Excellence in Pulmonary Fibrosis.
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests whether a new treatment is safe and effective in people, after it has already been studied in the laboratory. Participants are volunteers, and every trial is reviewed and monitored by an independent Human Research Ethics Committee to protect participants' safety and rights.
Will I receive a placebo instead of active treatment?
It depends on the trial design. Some trials compare a new treatment against a placebo (an inactive look-alike), while others compare it against the current standard of care. Where a placebo arm exists, most pulmonary fibrosis trials still allow participants to continue their existing antifibrotic therapy, with the trial treatment added on top. The trial's participant information sheet will explain exactly how that trial is designed before you decide whether to take part.
Can I stop taking part in a trial at any time?
Yes. Participation in a clinical trial is entirely voluntary, and you are free to withdraw at any stage without it affecting your ongoing medical care.
For referring clinicians
Dr Mackintosh welcomes referrals to discuss clinical trial eligibility for patients with IPF, progressive pulmonary fibrosis or other fibrotic ILDs.
Related
Idiopathic pulmonary fibrosis and progressive pulmonary fibrosis — the conditions most often considered for current trial options.