Interferon-gamma in CPA
Research type
Research Study
Full title
Interferon-gamma as adjunctive therapy in Chronic Pulmonary Aspergillosis: a randomised feasibility study
IRAS ID
1006489
Contact name
Chris Kosmidis
Contact email
Sponsor organisation
Manchester University NHS Foundation Trust
Research summary
The study explores treatment with interferon-gamma (IFNγ) in chronic pulmonary aspergillosis (CPA). CPA causes destruction of lung tissue by slowly enlarging cavities, frequent secondary infections and poor quality of life. Standard treatment is antifungal drugs but only 60% improve. We will randomly assign patients into two groups: half will receive standard-of-care antifungals and the other half will receive antifungals with IFNγ. This feasibility study will assess acceptability of IFNγ in CPA patients leading to a larger definitive study.
Treatment relies on antifungals for prolonged periods, but only around 60% of patients improve. It is often long-term as the response is slow. In addition, only one class of oral antifungal drugs is licensed for CPA, and they are associated with side effects and high cost. Better treatments are needed.
We do not know why many patients do not respond to treatment. Maybe CPA patients have a weakened immune system. Data states the immune system’s response against Aspergillus. IFNγ is already in use in the NHS for other indications. Therefore, its use in CPA should be explored. However, CPA is a rare condition and the tolerability of IFNγ is not fully established in these patients. To understand whether a large-scale study is feasible, we first need preliminary data in smaller numbers of patients.
We propose a randomised trial of IFNγ in addition to antifungals in CPA. Patients with CPA starting antifungal treatment will be eligible. Participants (25 per group) will be randomly assigned to IFNγ for 12 weeks (in addition to antifungals) or antifungals only. To test whether the treatment works, we will use measurements of the cavities on imaging and quality-of-life scores. Criteria for progression to a full study will be set based on proportion who complete the treatment. Data collected will allow us to determine the number needed for a definite study.REC name
Yorkshire & The Humber - Sheffield Research Ethics Committee
REC reference
23/YH/0069
Date of REC Opinion
19 Oct 2023
REC opinion
Further Information Favourable Opinion