Comparing Prednisolone and Itraconazole for Allergic Bronchopulmonary Aspergillosis
A Randomized Trial Comparing the Role of Prednisolone, Itraconazole, or Their Combination in Patients with Acute Stage of Allergic Bronchopulmonary Aspergillosis
PHASE3 · Post Graduate Institute of Medical Education and Research, Chandigarh · NCT06174922
This study is testing whether prednisolone, itraconazole, or a combination of both can help adults with allergic bronchopulmonary aspergillosis feel better and reduce flare-ups over a year.
Quick facts
| Phase | PHASE3 |
|---|---|
| Study type | Interventional |
| Enrollment | 300 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Post Graduate Institute of Medical Education and Research, Chandigarh (other) |
| Locations | 1 site (Chandigarh, Chandigarh) |
| Trial ID | NCT06174922 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the effectiveness of prednisolone, itraconazole, and their combination in treating patients with acute allergic bronchopulmonary aspergillosis (ABPA). A total of 300 participants aged 18 and older will be randomized to receive one of the three treatments for four months. The study aims to assess the rate of exacerbations in these patients over a 12-month period following treatment. Participants will be monitored through regular follow-ups to collect data on their health status and treatment outcomes.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 and older who have been diagnosed with acute ABPA and have uncontrolled asthma or worsening symptoms.
Not a fit: Patients who have experienced multiple ABPA exacerbations in the past 18 months or have contraindications to the study medications may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a more effective treatment regimen for patients suffering from acute ABPA, potentially reducing exacerbation rates.
How similar studies have performed: Previous studies have shown that itraconazole and voriconazole can be effective in treating ABPA, suggesting that this combination approach may also yield positive results.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Chandigarh, Chandigarh
- Chest Clinic, Dept. of Pulmonary Medicine — Chandigarh, Chandigarh, India (RECRUITING)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Allergic Bronchopulmonary Aspergillosis