Patient Trials

Currently Active ILD Studies and Studies due to start 2021/early 2022

GALACTIC

What is being tested?  GB0139 an experimental inhaled anti-fibrotic drug

Who is it for?  Patients with IPF diagnosed within the last 5 years, not currently taking anti-fibrotic therapy. With lung function tests FVC>45% predicted and DLCO 30%-79% predicted.

What does it involve? Randomised to study drug or placebo for 12 months of treatment.  8 visits to research centre at Southampton over 1-year period for lung function and blood tests.

Studies due to start later this year

TR-12 CANAL

Provisional Start date October/November 2021

What is being tested? Nalbuphine a synthetic morphine like medication which has been used for many years, in an injectable form, to treat certain types of pain. In the TR-12 study Nalbuphine  is being tested in an extended release tablet form for cough related to IPF.

Who is it for? People with cough related to IPF. With lung function tests FVC>45% predicted not already taking long term morphine related medications.

What does it involve? Randomised to drug or placebo for 3 weeks of treatment. Cross over study design; all patients receive the study drug either in 1st or 2nd treatment cycle.  Participants wear a cough monitor for 24 hours at the start and end of each treatment cycle.  Total of 10 visits over 4-6 months including lung function and blood tests.

TIPAL

Provisional Start date December 2021/January 2022

What is being tested? Lansoprazole a commonly used drug that reduces stomach acidity.

Although many patients with IPF take lansoprazole (or similar medications) its effectiveness as a treatment for IPF has not yet been proven in a definitive research study. The TIPAL study aims to answer this research question.

Who is it for? Any patient with IPF not on long-term oxygen therapy. Patients already taking lansoprazole or similar medications can participate if drug can be stopped prior to enrolment (medical exclusions apply). Patients with cough related to IPF may also enrol in the TIPAL cough sub-study.

What does it involve? Randomised to 1 year of lansoprazole or placebo. Weekly home spirometry assessment. 4 visits to the hospital over 1-year period for lung function and questionnaires. 24-hour cough monitor at enrolment and at 3 months for those in the cough sub-study

PATHOLOGICAL MECHANISMS OF PULMONARY FIBROSIS

What is being tested? Laboratory based study researching into the cellular causes of pulmonary fibrosis.

Who is it for? Patients with any type of interstitial lung disease undergoing bronchoscopy at University Hospital Southampton as part of their standard  NHS care.

What does it involve? If you choose to participate in the study a small additional sample of lung washing fluid will be taken for research investigating into the causes of pulmonary fibrosis.

If you would like more information about these studies please see here

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  ILDresearch@uhs.nhs.uk or tim.wallis@uhs.nhs.uk