Steroid combo may improve tough lung fungus treatment

NCT ID NCT05444946

Disease control Sponsor: Post Graduate Institute of Medical Education and Research, Chandigarh Source: ClinicalTrials.gov ↗

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study looks at people with a mix of two lung conditions caused by the fungus Aspergillus: chronic pulmonary aspergillosis and allergic bronchopulmonary aspergillosis. Researchers want to see if adding steroid pills to the standard antifungal drug itraconazole works better than itraconazole alone. About 104 adults will be randomly assigned to one of the two treatments and followed for a year to check if their symptoms and lung scans improve.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance: Itraconazole (oral antifungal) and prednisolone (oral steroid)
What this could lead to: If successful, this could establish a better treatment plan for people with both chronic and allergic aspergillosis, potentially improving symptoms and lung health.
What could go wrong: This is a small, early-stage trial with only 104 participants, so results may not apply to everyone. Adding steroids also carries risks like infection and side effects.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 104 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jun 2022

Expected to finish

Feb 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

15 to 90 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: Subjects fulfil criteria for ABPA and CPA as below. The criteria for CPA would include the presence of all the following: (i) one or more clinical symptoms (persistent cough, recurrent hemoptysis, weight loss, malaise, fever and dyspnea) for ≥3 months; (ii) slowly progressive or persistent findings (one or more cavities and surrounding fibrosis, infiltrates, consolidation, with or without fungal ball or progressive pleural thickening) on computed tomography (CT) of the thorax; (iii) immunological (A.fumigatus-specific IgG \>27 mgA/L or positive Aspergillus precipitins) or microbiological evidence of Aspergillus infection (growth of Aspergillus in respiratory secretions) and, (iv) exclusion of other pulmonary disorders with similar presentation. The diagnosis of ABPA will be made based on the presence of all the following: (a) A.fumigatus specific IgE \>0.35 kUA/L; (b) total IgE ≥500 IU/mL; (c) eosinophil count ≥500 cells/µL); (d) A.fumigatus IgG\>27 mgA/L. Exclusion Criteria: (i) failure to provide informed consent; (ii) patients on immunosuppressive drugs, intake of prednisolone (or equivalent) \>10 mg for at least 3 weeks or a diagnosis of human immunodeficiency virus syndrome; (iii) intake of antifungal triazoles for \>3 weeks in the preceding three months; (iv) subjects with active pulmonary infection due to mycobacterium tuberculosis or mycobacteria other than tuberculosis (MOTT); (v) subjects with others forms of pulmonary aspergillosis (subacute and acute invasive aspergillosis); and, (vi) pregnancy.

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Conditions

The condition(s) this trial relates to.

allergic bronchopulmonary aspergillosis aspergillosis invasive aspergillosis pulmonary aspergilloma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Allergic bronchopulmonary aspergillosis Chronic pulmonary aspergillosis

How to take part

Only the study team decides who joins. These are the ways to reach them.

The places running it

1 site. The list below names each one and where it is.
The official record

ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

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A doctor treating you

A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Steroid combo may improve tough lung fungus treatment

What the study statuses mean