NCT06174922 A Randomized Trial of Prednisolone, Itraconazole, or Their Combination in Allergic Bronchopulmonary Aspergillosis
| NCT ID | NCT06174922 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | Post Graduate Institute of Medical Education and Research, Chandigarh |
| Condition | Allergic Bronchopulmonary Aspergillosis |
| Study Type | INTERVENTIONAL |
| Enrollment | 300 participants |
| Start Date | 2023-12-01 |
| Primary Completion | 2026-06 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 300 participants in total. It began in 2023-12-01 with a primary completion date of 2026-06.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The investigators hypothesize that a combination of prednisolone and itraconazole would significantly reduce the exacerbation rate at one-year of patients with acute allergic bronchopulmonary aspergillosis (ABPA) compared to itraconazole or prednisolone monotherapy. In this study, 300 subjects aged ≥18 years with acute ABPA will be randomized to treatment with either prednisolone, itraconazole, or prednisolone plus itraconazole, all for four months each. After collecting baseline demographic, immunologic, and imaging data, the investigators will follow the patients every 2 months for the first two visits and then every four months for three visits. The primary outcome will be the proportion of subjects experiencing exacerbation (asthma or ABPA) 12 months after treatment completion.
Eligibility Criteria
Inclusion Criteria: Consecutive subjects of acute stage allergic bronchopulmonary aspergillosis (ABPA) complicating asthma per the revised ISHAM-ABPA working group criteria * newly diagnosed subjects with uncontrolled asthma or symptoms or radiology suggesting active lesions attributable to ABPA and meeting the diagnostic criteria of ABPA * those previously meeting the diagnostic criteria for ABPA and presenting with sustained (≥2 weeks) clinical or radiological worsening; and increase in serum total IgE by ≥50% of the last recorded IgE value during clinical stability. Exclusion Criteria: * occurrence of ≥3 ABPA exacerbations in the last 18 months before enrollment * contraindications to the use of either prednisolone or itraconazole * subjects who have received oral prednisolone (or equivalent) ≥30 mg for ≥2 weeks or itraconazole (or voriconazole or posaconazole or isavuconazole) for more than 2 weeks, in the last 3 months * chronic medical illnesses, including uncontrolled diabetes mellitus, chronic renal failure, chronic liver failure, chronic heart failure, and others * patient on immunosuppressive drugs * pregnancy * enrollment in another trial of ABPA * failure to provide informed consent * asthma exacerbation: worsening respiratory symptoms for at least 24 hours without immunological or radiological deterioration of ABPA * infective/bronchiectasis exacerbation: clinical deterioration for at least 24 hours with increase in cough; breathlessness; sputum volume or consistency; sputum purulence; fatigue, malaise, or fever; and hemoptysis without immunological or radiological deterioration of ABPA * serologic ABPA
Frequently Asked Questions
Who can join the NCT06174922 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Allergic Bronchopulmonary Aspergillosis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06174922 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 300 participants.
Is NCT06174922 currently recruiting?
Yes, NCT06174922 is actively recruiting participants. Visit ClinicalTrials.gov or contact Post Graduate Institute of Medical Education and Research, Chandigarh to inquire about joining.
Where is the NCT06174922 trial being conducted?
This trial is being conducted at Chandigarh, India.
Who is sponsoring the NCT06174922 clinical trial?
NCT06174922 is sponsored by Post Graduate Institute of Medical Education and Research, Chandigarh. The trial plans to enroll 300 participants.