RecruitingPHASE2INTERVENTIONAL

Interferon-gamma as Adjunctive Therapy in Chronic Pulmonary Aspergillosis: a Randomised Feasibility Study

We're exploring if adding a medication called interferon-gamma to standard antifungal treatment can improve the health of people living with chronic pulmonary aspergillosis (CPA). CPA is a long-lasting lung infection caused by a common fungus, often affecting those with other lung conditions like COPD or previous TB. Current treatments don't work for everyone, and we believe a weakened immune system might play a role. Interferon-gamma helps boost the immune system and has shown promise in earlier observations. This small study, called a feasibility study, will help us understand if a larger trial is possible, by looking at how many people are willing to take part and how well they tolerate the treatment. We'll also check if it helps reduce lung damage and improves how people feel day-to-day.

At a glance

Status

Recruiting

Phase

PHASE2

Sponsor

Manchester University NHS Foundation Trust

Enrolment target

Start

17 May 2024

Estimated completion

01 Dec 2026

Chronic Pulmonary Aspergillosis Aspergillosis

What is this study about?

This study is investigating a new approach for people with a long-term lung infection called chronic pulmonary aspergillosis, or CPA. CPA is caused by a common fungus and can slowly damage the lungs, often affecting those who already have other lung problems like COPD or have had tuberculosis. It can lead to worsening lung health and impact daily life, and is sometimes difficult to diagnose.

Current treatments for CPA involve taking antifungal medicines for a long time, sometimes for life. However, these treatments only help about 60% of patients, and there are limited options, which can have side effects. We believe that some people with CPA might have a weaker immune system, making it harder for their bodies to fight the infection. Our previous research suggests that people with CPA produce less of a substance called interferon-gamma, which is important for fighting off this fungus. We've also seen that giving interferon-gamma to some patients who weren't getting better with antifungals led to improvements in their lung health and reduced hospital visits.

Interferon-gamma is already used in the NHS for other conditions, so we want to see if it can also help people with CPA. Because CPA is quite rare, and we need to learn more about how well interferon-gamma is tolerated by these patients, we are starting with a small study. This initial study will help us work out if it's practical to carry out a bigger study in the future. We'll be looking at how many patients are interested in joining, how many complete the treatment, and if the treatment shows signs of helping improve their lung scans and quality of life.

Key takeaways

Exploring if a new treatment, interferon-gamma, can help people with CPA.
CPA is a long-term lung infection often impacting those with other lung diseases.
Current treatments for CPA don't work for everyone, highlighting a need for new options.
Interferon-gamma boosts the immune system and has shown early promise.
This is a small 'feasibility' study to see if a larger trial is possible.
Participation involves taking medication and regular check-ups, monitoring lung scans and quality of life.

Who may be eligible?

To join this study, you would need to have a confirmed diagnosis of chronic pulmonary aspergillosis (CPA). You should have started taking antifungal medication for your CPA within the last eight weeks, and shouldn't have been on any antifungal treatment for CPA in the eight weeks before that. We'd also need to see a recent CT scan of your chest from within the last six months.

There are a few reasons why you might not be able to take part. This includes if you have serious liver or kidney problems, or if you've recently had an active infection that might interfere with how we can assess the treatment. You also wouldn't be able to join if you are pregnant or breastfeeding, or if you've recently taken any interferon medication within the last six months. We also can't include individuals taking high doses of steroids or similar medications that suppress the immune system.

Finally, you would need to be able to give yourself the study medication by injection under the skin, or have a carer who can do this for you. All participants must be over 18 years old.

Quick self-check

Do I have a diagnosis of chronic pulmonary aspergillosis (CPA)?
Have I started antifungal treatment for CPA within the last 8 weeks?
Do I have any severe liver or kidney problems?
Am I pregnant or breastfeeding, or have I used interferon in the last 6 months?
Am I over 18 years old?
Can I, or a carer, give injections under the skin?

This is a guide only — the research team will confirm whether you can take part.

What does participation involve?

If you decide to take part in this study, you'll be randomly assigned to one of two groups: either you'll receive interferon-gamma injections for 12 weeks in addition to your usual antifungal medication, or you'll continue with your usual antifungal medication alone. This is decided by chance, like flipping a coin. You will be asked to give yourself (or have a carer give you) the interferon-gamma injections under the skin.

During the study, we will check your health at regular intervals, similar to what happens in standard clinic visits. This will help us understand how well you are tolerating the treatment. We will also perform chest CT scans to track changes in the lung cavities caused by CPA, and ask you to complete questionnaires about your quality of life to see how you are feeling day-to-day. The total duration of the interferon-gamma treatment would be 12 weeks, but we would continue to monitor your health and progress beyond this to see how you are doing.

Potential risks and benefits

Taking part in any study has potential benefits and risks. A potential benefit of this study is that adding interferon-gamma might improve your CPA, reduce the damage to your lungs, and enhance your quality of life. However, as this is a research study, there's no guarantee that you will personally benefit from the treatment. Interferon-gamma can have side effects, and we will be carefully monitoring your health to understand how well it is tolerated in people with CPA. You will be fully informed of all known side effects before making a decision. You are free to withdraw from the study at any time, for any reason, without it affecting your ongoing medical care.

Locations (1)

Manchester University NHS Foundation Trust
Manchester, United Kingdom· Recruiting

Common questions

What is chronic pulmonary aspergillosis (CPA)?

CPA is a long-term lung infection caused by a common fungus called Aspergillus. It can slowly damage your lungs and often affects people with other lung conditions.

What is interferon-gamma and how might it help?

Interferon-gamma is a natural substance that helps boost your immune system. We believe it might help your body fight the Aspergillus fungus more effectively.

Will I definitely get the new treatment?

No, this is a 'randomised' study. You will be randomly assigned to either receive interferon-gamma plus your usual medication, or your usual medication alone.

How long will the treatment part of the study last?

If you are in the interferon-gamma group, you will take the study medication for 12 weeks, alongside your usual antifungal treatment.

What if I change my mind about participating?

You are free to withdraw from the study at any time, for any reason, without telling us why. This will not affect your medical care.

How to find out more

Chris Kosmidis, MD

chris.kosmidis@manchester.ac.uk 01612915875 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.