Patient Trials

Current ILD studies recruiting

- AT UNIVERSITY HOSPITAL SOUTHAMPTON FEB 2019

MA39189

What is being tested? Pirfenidone, an anti-fibrotic drug used to treat IPF.

Who is it for? Patients with unclassifiable pulmonary fibrosis (i.e. the lung fibrosis does not fit neatly into any particular diagnosis and so was deemed by clinicians to be unclassifiable) which is progressive (as determined by lung function or scoring of breathlessness).

What does it involve? Treatment with either pirfenidone or placebo for 24 weeks followed by an open label trial (i.e. all patients get pirfenidone) for 12 months. 10 hospital visits at least.

Exercise in IPF

What is being tested? An 8 week tailor-made cycle-based fitness regimen.

Who is it for? Patients with a diagnosis of IPF who are NOT actively on other trials

What does it involve? Twice weekly cycle-based exercise training, with monitoring on cardiopulmonary exercise training (CPET) machines, blood tests and lung function for 8 weeks.

Celegene

What is being tested? CC-90001, an experimental drug which may stop a protein that is thought to be involved in the IPF process.

Who is it for? Patients with IPF not currently on anti-fibrotic treatment, who have mild to moderate IPF (FVC >45% and DLCO 30-85%)

What does it involve? Randomised to drug or placebo and treated initially for 24 weeks and then possibly another 28 weeks. Between 9 and 15 hospital visits. Blood tests, lung function and CT scan.

TRAIL1

What is being tested? Pirfenidone, an anti-fibrotic drug used to treat patients with IPF

Who is it for? Patients with Rheumatoid Arthritis-associated Interstitial Lung Disease (RAILD). RAILD has many similar characteristics to IPF and this study will see if pirfenidone is effective in RAILD.

What does it involve? Randomised to drug versus placebo. 12 months of treatment involving 8 hospital visits, lung function a CT scan and blood tests

Time to diagnosis in IPF

What is being tested? How the length of time taken to reach a diagnosis and treatment may affect the tolerance and duration of treatment as well as other outcome like lung transplant and mortality.

Who is it for? All patients diagnosed with IPF in the past 5 years.

What does it involve? Nothing required from participants. The ILD team will look at referring dates from all patients with IPF and clinical information relevant to their IPF journey. The information collected will be de-identified (no information that is analysed can be traced back to the patient) and the research will be performed with the usual confidentiality of the NHS (no-one outside of the treating ILD team will see the medical records).

Phase 1 IPF – BI

What is being tested? The safety and tolerability of a new drug anti-fibrotic drug ‘BI 1015550’  in IPF

Who is it for? Part 1: All patients with IPF not currently taking nintedanib or pirfenidone. Part 2: All patients with IPF

What does it involve? BI 1015550 is an experimental drug not currently licensed for treatment. Early phase studies on new medications are standard procedure and are very closely monitored to ensure safety. This drug has previously been tested in animals and healthy subjects. Your participation in the study may last up to 17 weeks and requires 13 visits to Southampton General. The study will require you to stay overnight at during at least one of the visits. During the study you will be assigned by random to take either small increasing doses of BI 1015550 or placebo. The study requires adherence to a specific diet and to refrain from alcohol for a period during the study.

RECITAL

What is being tested? Comparing two injectable treatments for Connective tissue disease – ILD: rituximab and cyclosphosphamide

Who is it for? Patients with a diagnosis of systemic sclerosis, idiopathic inflammatory myopathy or mixed connective tissue disease and ILD

What does it involve? 4 weekly injections for 20 weeks. Lung Function. 6 Minute Walk Test. Health Questionnaires.

Read more about the clinical trails: Current ILD studies Feb 2019.pdf

trials coming to southampton soon

The research team are currently in negotiation with pharmaceutical companies over participation in at least 4 additional trials in Pulmonary Fibrosis, and we will keep everyone updated as more details emerge.

For more info please email  [email protected]  or [email protected]