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

Launched by MANCHESTER UNIVERSITY NHS FOUNDATION TRUST · Dec 13, 2022

Keywords

ClinConnect Summary

This clinical trial is studying whether adding interferon-gamma to standard antifungal treatment can help improve outcomes for patients with chronic pulmonary aspergillosis (CPA), a long-lasting lung infection caused by a fungus. CPA often affects people with ongoing lung conditions, leading to worsening lung function and quality of life. Researchers believe that interferon-gamma may help boost the immune response against the fungus, especially since some patients don’t respond well to existing antifungal treatments.

To be eligible for the trial, participants need to have a confirmed diagnosis of CPA and have started antifungal treatment within the last two weeks. They should also have a recent chest CT scan to assess their condition. The trial will involve 50 participants who will be randomly assigned to receive either interferon-gamma along with antifungals or antifungals alone for 12 weeks. During this time, researchers will monitor how well the treatments work and check for any side effects. If successful, this study could lead to better treatment options for CPA and other chronic lung diseases in the future.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Diagnosis of CPA
• • Started antifungal treatment for CPA within the last 8 weeks and received no antifungals for CPA in the 8 weeks prior
• • Chest CT scan available within the 6 months prior to enrolment
• • Individuals of child bearing potential agree to have pregnancy test an use highly effective contraception
• Exclusion Criteria:
• • Moderate to severe liver dysfunction (Child-Pugh Class B or C)
• • Renal failure (eGFR \<30 mL/min)
• • Clinically diagnosed active depression
• • Active tuberculosis or non-tuberculous mycobacterial (NTM) lung disease
• • Acute infection or other event within the preceding 4 weeks which, as assessed by the investigators, might interfere with the assessment of response to treatment
• • Use of any interferon formulation within the preceding six months
• • Active viral hepatitis infection
• • Pregnancy or breastfeeding
• • Immunosuppression (\>15mg prednisolone/day for at least four weeks or equivalent) within the preceding six months
• • Inability to self-administer subcutaneous medications AND lack of a carer who can administer
• • Participants lacking capacity to consent