Patient Trials

Current Trials - still recruiting

- AT UNIVERSITY HOSPITAL SOUTHAMPTON

RECITAL

A randomised, double blind controlled trial comparing rituximab against intravenous cyclophosphamide in connective tissue disease (CTD) associated interstitial lung disease.

What is being tested?
Two drugs (Rituximab and Cyclophosphamide) which work in different ways to suppress the abnormal immune response that may lead to connective tissue disease-associated interstitial lung disease (CTD-ILD). These drugs are both available on the NHS for other reasons however there it is unknown which one is most effective for CTD-ILD.

Who is it for?
atients with an interstitial lung disease AND one of the following connective tissue disease: systemic sclerosis, idiopathic inflammatory myopathy (e.g. polymyositis or dermatomyositis) or mixed connective tissue disease.

What does it involve?
Either rituximab or cyclophosphamide for 20 weeks . 10 patient visits to Southampton Hospital for blood tests, lung function tests, treatment and occasional other investigations.

EME-TIPAC

What is being tested?
Co-trimoxazole, a broad spectrum antibiotic which previous research has shown may improve quality of life and reduce hospital admission in patients with IPF.

Who is it for?
Patients with IPF that is moderate to severe (FVC < 75%). Patients can already be on other treatment (nintedanib/pirfenidone)

What does it involve?
12 – 42 months with hospital visits at 6 weeks, 3 months, 6 months, 9  months and then every 6 months

IPF – JES

What is being tested?
Occupational exposure to asbestos in patients with IPF. Absestos-ILD (asbestosis) can look similar to IPF and this study will investigate if a proportion of IPF is actually caused by occupational exposure to asbestos.

Who is it for?
All patients with IPF (even those already on other studies)

What does it involve?
A blood test (to look for genetic features which might relate to asbestos exposure) and a telephone interview

trials coming to southampton soon

B.I. 1305-0012 phase 1 study

Safety, tolerability, and pharmacokinetics of multiple rising oral doses of BI 1015550 in patients with idiopathic pulmonary fibrosis (IPF) on no background anti-fibrotic (Part 1) and safety and tolerability of BI 1015550 on top of Nintedanib and Pirfenidone (Part 2).

What is being tested?
A new drug (BI 1015550) which is believed to possess anti-fibrotic properties that may slow down the scarring process in Idiopathic Pulmonary Fibrosis. It has never been tested in these patients before.

Who is it for?
Patients with IPF and lung function (FVC) > 50%. The study has two parts:
1. For patients who are not currently on anti-fibrotic therapy
2. For patients who are currently on either pirfenidone or nintedanib

What does it involve?
Because this trial is phase 1 (new drug being tested for the first time in IPF), the study involves 5 – 13 weeks with 9 – 13 visits for blood tests, lung function, questionnaires, treatment and other investigations. At least 1 visit would require overnight stay in the hospital to test drug levels regularly.

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 (based on lung function – Forced Vital Capacity >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

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