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Contact the study team using the details below to take part. If there are no contact details below please ask your doctor in the first instance.
Chris
Kosmidis
chris.kosmidis@manchester.ac.uk
Chris
Kosmidis
chris.kosmidis@manchester.ac.uk
Mycoses
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This study explores the role of treatment with interferon-gamma (IFNÎł) to improve outcomes in chronic pulmonary aspergillosis (CPA). CPA is a progressive infection caused by the fungus Aspergillus affecting patients with chronic lung disease like COPD or previously treated TB. It causes gradual destruction of lung tissue by slowly enlarging cavities ,frequent secondary infections and poor quality of life. Because of its indolent nature and non-specific x-ray findings, it often remains unrecognised for years. Around 3600 people live with CPA in the UK.
Mortality from CPA may be up to 40% in five years.
Treatment for CPA relies on antifungals for prolonged periods, but only around 60% of patients improve. It is often long-term or lifelong as the response is slow and some patients experience relapses. 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 for CPA.
We do not know why many patients do not respond to treatment. Maybe CPA patients have a weakened immune system and are more susceptible to Aspergillus. Our data suggest that CPA patients produce lower amounts of ΙFNγ,a substance that facilitates the immune system’s response against Aspergillus. We have also shown that, when given to patients with CPA who have failed to improve on antifungal treatment,IFNγ leads to improvement in important patient-centred outcomes like flares of lung disease or hospital admissions. 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 in CPA, we first need preliminary data in smaller numbers of patients.
We propose a randomised trial of IFNÎł in addition to antifungals in CPA. Patients with CPA starting antifungal treatment will be eligible. Participants (25 per group) will be randomly assigned to IFNÎł for 12 weeks (in addition to antifungals) or antifungals only. To test whether the treatment works, we will use measurements of the cavities on
chest CT scan and scores on a quality-of-life questionnaire. We will assess for tolerability of treatment at intervals similar to clinical practice. Criteria for progression to the large-scale study will be set based on the proportion of patients willing to participate, and on the proportion who complete the treatment. Data collected on those
parameters will allow us to determine the number needed for a definite study.
If the large-scale study confirms our observations that IFNÎł improves outcomes in CPA, then treatment duration can be shortened and relapses avoided. In addition,IFNÎł can then be explored in other chronic lung disease.
Start dates may differ between countries and research sites. The research team are responsible for keeping the information up-to-date.
The recruitment start and end dates are as follows:
Interventional type: Drug;
You can take part if:
You may not be able to take part if:
• 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,defined as receiving antimycobacterial treatment,or at least two positive sputum cultures with a clinically relevant (as assessed by the investigators) NTM isolate within the preceding year • 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
Below are the locations for where you can take part in the trial. Please note that not all sites may be open.
The study is sponsored by MANCHESTER UNIVERSITY NHS FOUNDATION TRUST and funded by NIHR Central Commissioning Facility (CCF) .
Your feedback is important to us. It will help us improve the quality of the study information on this site. Please answer both questions.
Read full details
for Trial ID: CPMS 55735
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