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A clinical trial to study the efficacy of two different drug regimen in ABPA cases.

Efficacy of short course prednisolone in combination with itraconazole compared to prednisolone alone in treatment naive allergic broncho pulmonary aspergillosis; a randomized control trial - NIL

Status
Active, not recruiting
Phases
Phase 2Phase 3
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2024/12/077735
Enrollment
120
Registered
2024-12-06
Start date
Unknown
Completion date
Unknown
Last updated
2024-12-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: J708- Respiratory conditions due to other specified external agents

Interventions

Intervention1: Prednisolone,Itraconazole: Tablet Prednisolone(1 month)–Capsule Itraconazole(4month) (The dosage of prednisolone Would be 0.5 mg/kg for the first week, followed by 0.25 mg/kg for the s

Sponsors

Jisha G Panicker
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Treatment-naive acute-stage ABPA and included them if they met the following criteria: 1.Aspergillus fumigatus-specific IgE levels >0.35 kUA/L or immediate cutaneous hyperreactivity on Aspergillus skin test. 2.Elevated serum total IgE levels >500 IU/ML and two of the following a) Presence of precipitating antibodies (or IgG >27 mg/L) against Aspergillus fumigatus in serum. b)Peripheral blood eosinophilia >500 µL, c) Chest radiographic and/or computed tomography (CT) abnormalities consistent with Allergic Bronchopulmonary aspergillosis.

Exclusion criteria

Exclusion criteria: 1.Not giving consent for the study enrolment. 2.intake of systemic glucocorticoids or triazoles for morethan 3 weeks in the preceding 6 months 3.concomitant use of medications, including voriconazole, inhaled amphotericin B,omalizumab or other biological agents 4.uncontrolled diabetes mellitus 5.chronic renal failure, 6.chronic liver failure 7.patients on immunosuppressive drugs 8.Pregnant females.

Design outcomes

Primary

MeasureTime frame
To compare the remission rates at 3 and 6 months following the completion of a 4 month treatment course in each group.Timepoint: baseline, 6 weeks, 16 weeks, 28 weeks, 40 weeks

Secondary

MeasureTime frame
To compare treatment related adverse effects in both groups. Timepoint: 6 weeks, 4 months after starting treatment;To compare clinical response rates at 6 weeks and 4 months on both groupsTimepoint: 6weeks, 4months after starting treatment

Countries

India

Contacts

Public ContactJisha G Panicker

AIIMS Patna

drsomesht@aiimspatna.org9304907327

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026