Chronic Pulmonary AspergillosisPhase 2INCASNCT05653193
Interferon-gamma as Adjunctive Therapy in Chronic Pulmonary Aspergillosis: a Randomised Feasibility Study
A Phase 2 study of Chronic Pulmonary Aspergillosis and Aspergillosis, run by Manchester University NHS Foundation Trust at 1 site in United Kingdom.
Trial summary
This study explores the role of treatment with interferon-gamma 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 Chronic Obstructive Lung Disease (COPD) or previously treated tuberculosis… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Pulmonary Aspergillosis, Aspergillosis
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 17 May 2024to Dec 2026
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 11Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Manchester University NHS Foundation Trust
Manchester, M23 9LT
About this study
This study explores the role of treatment with interferon-gamma 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 Chronic Obstructive Lung Disease (COPD) or previously treated tuberculosis (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 nonspecific x-ray findings, it often remains unrecognised for years. Around 3600 people live with CPA in the United Kingdom. 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, interferon-gamma leads to improvement in important patient-centred outcomes like flares of lung disease or hospital admissions. Interferon-gamma is already in use in the National Health Service of the United Kingdom for other indications. Therefore, its use in CPA should be explored. However, CPA is a rare condition and the tolerability of interferon-gamma 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.
Read more
We are conducting a randomised trial of interferon-gamma in addition to antifungals in CPA. Patients with CPA starting antifungal treatment are eligible. Participants (25 per group) are randomly assigned to interferon-gamma 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 interferon-gamma improves outcomes in CPA, then treatment duration can be shortened and relapses avoided. In addition, interferon-gamma can then be explored in other chronic lung disease.
- Conditions
- Chronic Pulmonary Aspergillosis, Aspergillosis
- Being tested
- Interferon Gamma-1B 0.1 MG Per 0.5 ML Injection PLUS antifungals as standard of care, Antifungals as standard of care
- Keywords
- immunotherapy, interferon gamma
- Medical subject headings
- Aspergillosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Interferon Gamma-1B 0.1 MG Per 0.5 ML Injection PLUS antifungals as standard of careDrug
Patients starting oral antifungal treatment for chronic pulmonary aspergillosis will be randomised 1:1 to additional interferon-gamma for 3 months or no additional treatment.
Antifungals as standard of careDrug
Patients starting oral antifungal treatment for chronic pulmonary aspergillosis will be randomised 1:1 to additional interferon-gamma for 3 months or no additional treatment.
| Study group | Role | What they receive |
|---|---|---|
| Antifungal | Active comparator | Any oral triazole antifungal as per routine care Receives: Drug: Antifungals as standard of care |
| Antifungal plus inteferon gamma | Experimental | Any oral triazole antifungal as per routine care plus interferon-gamma three times weekly subcutaneously 50 micrograms/m2 for 3 months Receives: Drug: Interferon Gamma-1B 0.1 MG Per 0.5 ML Injection PLUS antifungals as standard of care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of participants retained in the intervention arm
Measured: 6 months
Proportion of target sample achieved
Measured: 3 years
Change in maximum cavity wall thickness on CT scan
Measured: 6 months
Secondary outcomes (2)
Change in St George's Respiratory Questionnaire (SGRQ) score
The SGRQ ranges from 0-100 with higher scores indicating worse quality of life
Measured: 3 and 6 months
Number of exacerbations requiring antibiotics or steroids in the six months before and after starting treatment
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Dec 2022
- Study start17 May 2024
- Primary completionNov 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Pulmonary AspergillosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Manchester University NHS Foundation Trust
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Chris Kosmidis, MD, Principal investigator, Manchester University NHS Foundation Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05653193
- Sponsor's protocol ID
- B01674
- Acronym
- INCAS
- Status last verified
- Aug 2026
- First submitted
- 29 Nov 2022
- Last updated
- 18 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Interferon-gamma as Adjunctive Therapy in Chronic Pulmonary Aspergillosis: a Randomised Feasibility Study
- ClinicalTrials.gov ID
- NCT05653193
- Acronym / sponsor ID
- INCAS / B01674
- Conditions
- Chronic Pulmonary Aspergillosis, Aspergillosis
- Keywords
- immunotherapy, interferon gamma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Manchester University NHS Foundation TrustOther government
- Study start
- 17 May 2024 (actual)
- Primary completion
- Nov 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 16 Dec 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study explores the role of treatment with interferon-gamma 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 Chronic Obstructive Lung Disease (COPD) or previously treated tuberculosis (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 nonspecific x-ray findings, it often remains unrecognised for years. Around 3600 people live with CPA in the United Kingdom. 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, interferon-gamma leads to improvement in important patient-centred outcomes like flares of lung disease or hospital admissions. Interferon-gamma is already in use in the National Health Service of the United Kingdom for other indications. Therefore, its use in CPA should be explored. However, CPA is a rare condition and the tolerability of interferon-gamma 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 are conducting a randomised trial of interferon-gamma in addition to antifungals in CPA. Patients with CPA starting antifungal treatment are eligible. Participants (25 per group) are randomly assigned to interferon-gamma 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 interferon-gamma improves outcomes in CPA, then treatment duration can be shortened and relapses avoided. In addition, interferon-gamma can then be explored in other chronic lung disease.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Antifungal | Active comparator | Drug: Antifungals as standard of careAny oral triazole antifungal as per routine care |
| Antifungal plus inteferon gamma | Experimental | Drug: Interferon Gamma-1B 0.1 MG Per 0.5 ML Injection PLUS antifungals as standard of careAny oral triazole antifungal as per routine care plus interferon-gamma three times weekly subcutaneously 50 micrograms/m2 for 3 months |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Interferon Gamma-1B 0.1 MG Per 0.5 ML Injection PLUS antifungals as standard of carePatients starting oral antifungal treatment for chronic pulmonary aspergillosis will be randomised 1:1 to additional interferon-gamma for 3 months or no additional treatment. | Drug | Antifungal plus inteferon gamma |
| Antifungals as standard of carePatients starting oral antifungal treatment for chronic pulmonary aspergillosis will be randomised 1:1 to additional interferon-gamma for 3 months or no additional treatment. | Drug | Antifungal |
Primary outcome
Proportion of participants retained in the intervention arm
Time frame: 6 months
Proportion of target sample achieved
Time frame: 3 years
Change in maximum cavity wall thickness on CT scan
Time frame: 6 months
2 secondary outcomes
Change in St George's Respiratory Questionnaire (SGRQ) score
Time frame: 3 and 6 months
Number of exacerbations requiring antibiotics or steroids in the six months before and after starting treatment
Time frame: 1 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Aug 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Chris Kosmidis, MD principal investigator
Manchester University NHS Foundation Trust
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study of Chronic Pulmonary Aspergillosis and Aspergillosis, run by Manchester University NHS Foundation Trust at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 18 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of participants retained in the intervention arm (time frame: 6 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Aug 2026.