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PATIENT TRIALS

CURRENTLY ACTIVE ILD STUDIES AND STUDIES DUE TO START 2026

STUDIES OPEN TO RECRUITMENT
we are looking for patients now!

M25-268 ABBVIE

What is being tested?
An investigational drug called ABBV-142 that targets a receptor which plays a role in the formation of lung fibrosis.

Who is it for?
Adults with a confirmed diagnosis of IPF, who are either receiving stable antifibrotic treatment (nintedanib or pirfenidone) or are not currently receiving antifibrotic therapy.

What does it involve?
Participants receive an intravenous infusion of ABBV-142 or placebo every 4 weeks for up to 52 weeks, with regular outpatient visits for lung function tests, blood tests, ECGs, walking assessments, and safety monitoring.

Trial Objective?
To assess the safety, tolerability, and effectiveness of ABBV-142 and determine whether it can help slow the decline in lung function in people with IPF.


BEET-IPF

What is being tested?
The effect of nitrate rich beetroot juice on exercise capacity in people with IPF.

Who is it for?
Adults aged 18-85 with IPF.

What does it involve?
Participants will receive either nitrate-rich beet juice or nitrate-deplete beet juice (a placebo). Assessment of exercise capacity will be undertaken as well as lung function and blood tests. You will be asked to complete a food diary during the study. This will be followed by a one-week break before participants will crossover to receive the other type of beet juice and the process repeated.


BREEZE-2

What is being tested?
Whether a breathlessness management programme improves symptoms in people with pulmonary fibrosis.

Who is it for?
People who have been diagnosed with IPF of another fibrotic ILD who have significant breathlessness and have not undertaken pulmonary rehabilitation within the past 3 months.

What does it involve?
Breathlessness management training will happen in-person at Southampton General Hospital for two sessions and the third session will be by telephone. Participants will be randomised to start this programme within 1 week, or at 8 weeks. You will be followed up for up to one year via telephone to monitor symptoms, quality of life, and healthcare use.

Trial Objective?
To determine whether the breathlessness intervention can improve symptoms.


CHORUS

What is being tested?
The effectiveness of prednisolone (an oral steroid) in people with newly diagnosed fibrotic Hypersensitivity Pneumonitis (fHP).

Who is it for?
Adults who have recently been diagnosed with fibrotic hypersensitivity pneumonitis.

What does it involve?
Participants will be allocated to either receive oral prednisolone or placebo over a 6-month period and will attend scheduled clinic and telephone visits involving lung function tests, symptom questionnaires, and safety assessments.

Trial Objective?
To determine whether prednisolone improves lung function in people with newly diagnosed fibrotic hypersensitivity pneumonitis.


PROPEL-IPF

What is being tested?
An investigational oral medication called PIPE-791 that blocks a receptor within a pathway involved in the formation of lung fibrosis. Researchers will compare two doses of PIPE-791 with placebo to see if it can slow the loss of lung function.

Who is it for?
Adults with IPF who are either on stable treatment with nintedanib or pirfenidone, or who are not taking antifibrotic therapy.

What does it involve?
Participants take a daily tablet of PIPE-791 or placebo for 26 weeks and attend regular study visits for lung function tests, blood and urine tests, ECGs, CT scans, questionnaires, and safety assessments.

Trial Objective?
To evaluate the safety and effectiveness of PIPE-791 and determine whether it can reduce the decline in lung function in people with IPF compared with placebo.


INSMED PALM-ILD

What is being tested?
The study is testing an inhaled treatment called Treprostinil Palmitil Inhalation Powder (TPIP), designed to improve exercise capacity and symptoms in people with pulmonary hypertension associated with interstitial lung disease (PH-ILD).

Who is it for?
Adults with pulmonary hypertension caused by interstitial lung disease who meet specific heart and lung function criteria and are on stable treatment for their condition.

What does it involve?
Participants use a dry powder inhaler containing Treprostinil or placebo, once daily for 24 weeks. You would attend regular outpatient visits for walking tests, blood tests, ECGs, questionnaires, and monitoring of symptoms and side effects.

Trial Objective?
The aim of the study is to determine whether TPIP can improve exercise capacity, reduce disease worsening, and provide a safe treatment option for people with pulmonary hypertension associated with ILD.


ZAPPHIRE

What is being tested?
An intravenous drug called zampilimab that targets a protein thought to contribute to lung fibrosis in IPF.

Who is it for?
Adults diagnosed with IPF who are either receiving stable antifibrotic treatment (e.g. nintedanib or pirfenidone) or not currently on any antifibrotic treatment.

What does it involve?
Participants receive an intravenous infusion of zampilimab or placebo every 3 weeks for a total of 8 infusions over 21 weeks. Regular assessments include lung function tests, blood and urine tests, and monitoring for any side-effects.

Trial Objective?
To determine whether zampilimab can slow the decline in lung function in people with IPF, while evaluating its safety and any side-effects.


PATHOLOGICAL MECHANISMS

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

Who is it for?
People 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.

UPCOMING STUDIES
we will need patients soon, get on the waiting list!

OCEAN-1

What is being tested?
A tablet medication called Nalbuphine Extended-Release (NAL ER), designed to reduce chronic cough in people with IPF. This is a Phase 3 study, following promising results from the previous Phase 2 study (CORAL) in reducing cough in people with IPF.

Who is it for?
Adults with a diagnosis of IPF who have been experiencing chronic cough for at least 8 weeks. Participants may continue current antifibrotic treatment such as nintedanib or pirfenidone during the study.

What does it involve?
Participants take NAL ER tablets or placebo for up to 54 weeks. You would attend regular study visits and complete cough monitoring, questionnaires, lung function tests, blood tests, and safety assessments.

Trial Objective?
To determine whether NAL ER can safely reduce the frequency and severity of chronic cough and improve quality of life in people with IPF.


CLI-010073AA1-02

What is being tested?
An inhaled medication called CHF10073 that blocks proteins involved in lung fibrosis.

Who is it for?
Adults with a diagnosis of IPF who may be receiving stable antifibrotic treatment or may not be receiving any antifibrotic treatment.

What does it involve?
Participants inhale CHF10073 or placebo via a dry powder inhaler once daily for 28 days and attend regular study visits for lung function testing, blood tests, questionnaires, and safety monitoring.

Trial Objective?
To evaluate the safety, tolerability, and how the body processes CHF10073, while also collecting preliminary information on its effects on cough and lung disease in people with IPF.

CLOSED
these studies are still running but we do not need any more patients!

TIPAL

What is being tested?
Lansoprazole, a commonly used drug that reduces stomach acidity. Although many people 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?
People with IPF not on long-term oxygen therapy. Those already taking lansoprazole or similar medications can participate if drug can be stopped prior to enrolment (medical exclusions apply). People 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.


FIBRONEER OPEN LABEL EXTENSION

What is being tested?
The study is investigating a medication called nerandomilast, a type of medication called a PDE4 inhibitor. The research trial will determine the safety and efficacy of nerandomilast long-term.

Who is it for?
Adults diagnosed with Progressive Fibrosing Interstitial Lung Diseases (PF-ILDs) who were on the parent (placebo-controlled) trial and completed the trial.

What does it involve?
Participants will receive nerandomilast and have regular assessments as an outpatient. Assessments include blood and urine tests, questionnaires, physical exams, ECGs, spirometry, DLCO. Nerandomilast will be evaluated both as a stand-alone treatment and alongside antifibrotic treatments like nintedanib.

Trial Objective?
The purpose of this trial is to determine to long term tolerability, safety and efficacy of nerandomilast in people with IPF and other PF-ILDs.