Actively Recruiting
Interferon-gamma as Adjunctive Therapy in Chronic Pulmonary Aspergillosis: a Randomised Feasibility Study
Led by Manchester University NHS Foundation Trust · Updated on 2025-03-03
50
Participants Needed
1
Research Sites
4 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the use of interferon-gamma as an additional treatment to improve outcomes in people with chronic pulmonary aspergillosis (CPA), a progressive lung infection caused by the fungus Aspergillus. CPA mainly affects individuals with chronic lung diseases like COPD or those previously treated for tuberculosis. This condition causes gradual lung tissue damage, frequent infections, and reduced quality of life, often going unrecognized for years. Current treatment relies on prolonged antifungal use, but many patients do not respond well, and better treatment options are needed. This phase 2 study aims to gather preliminary data on interferon-gamma’s tolerability and potential benefits in CPA patients. Participants who have recently started oral antifungal treatment for CPA are randomly assigned to receive either antifungals alone or antifungals plus interferon-gamma injections three times a week for 12 weeks. The interferon-gamma dose is 50 micrograms per square meter of body surface area given subcutaneously. Both groups will continue antifungal therapy as per routine care. The study will assess changes in lung cavity size using chest CT scans and quality of life through questionnaires. Treatment tolerability will be monitored at intervals similar to regular clinical practice. During the study, participants will undergo chest CT scans and complete quality-of-life assessments at various time points up to six months. Researchers will track lung disease flare-ups and hospital admissions. The primary outcomes include the number of participants who complete the intervention and changes in cavity wall thickness on CT scans. Secondary outcomes include changes in respiratory health questionnaire scores and frequency of lung exacerbations. Study participation may last up to one year, with data collected to inform a larger future trial if results are promising.
CONDITIONS
Brief Title
Interferon-gamma as Adjunctive Therapy in Chronic Pulmonary Aspergillosis: a Randomised Feasibility Study
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosis of chronic pulmonary aspergillosis (CPA)
- Started antifungal treatment for CPA within the last 8 weeks and no antifungal treatment for CPA in the 8 weeks prior
- Chest CT scan available within the 6 months prior to enrollment
- Individuals of childbearing potential agree to have a pregnancy test and use highly effective contraception
You will not qualify if you...
- Moderate to severe liver dysfunction (Child-Pugh Class B or C)
- Renal failure with eGFR less than 30 mL/min
- Clinically diagnosed active depression
- Active tuberculosis or non-tuberculous mycobacterial lung disease
- Acute infection or other event within the preceding 4 weeks that might interfere with treatment assessment
- Use of any interferon formulation within the preceding six months
- Active viral hepatitis infection
- Pregnancy or breastfeeding
- Immunosuppression with more than 15mg prednisolone per day for at least four weeks within the preceding six months
- Inability to self-administer subcutaneous medications and no carer to assist
- Participants lacking capacity to consent
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 3 months
Participants receive oral antifungal treatment for chronic pulmonary aspergillosis, with some also receiving interferon-gamma injections three times weekly for 3 months.
Weekly visits for up to 12 weeks
Duration - Up to 6 months
Participants are monitored for treatment outcomes and safety for up to 6 months after treatment.
Visits at 3 and 6 months post-treatment
Trial Site Locations
Total: 1 location
1
Manchester University NHS Foundation Trust
Manchester, United Kingdom, M23 9LT
Actively Recruiting
Research Team
C
Chris Kosmidis, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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