Tokyo, Dec. 1 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000059914) titled 'Efficacy and safety of short-course corticosteroid treatment for mild allergic bronchopulmonary aspergillosis complicating asthma' on Dec. 1.

Study Type: Interventional

Study Design: Basic Design - Parallel Randomization - Randomized Blinding - Open -no one is blinded Control - Active

Primary Sponsor: Institute - Tokai University

Condition: Condition - Allergic bronchopulmonary aspergillosis complicating asthma Classification by malignancy - Others Genomic information - NO

Objective: Narrative objectives1 - The standard treatment for acute allergic bronchopulmonary aspergillosis (ABPA) consisting of 4-6 months of oral corticosteroid therapy results in high treatment failure rate. On the other hand, the high cumulative dose of corticosteroid is associated with a substantial risk of adverse events among mild cases who achieve successful treatment. In this study, acute ABPA will be stratified into refractory and mild cases using the difficult-to-treat ABPA score developed by the investigators. The primary objective is to evaluate the efficacy and safety of short-course corticosteroid monotherapy in mild cases through a multicenter randomized controlled trial. Basic objectives2 - Safety,Efficacy

Intervention: Interventions/Control_1 - Standard corticosteroid treatment Oral prednisolone administration for 16 weeks. Interventions/Control_2 - Short-course corticosteroid treatment Oral prednisolone administration for 10 weeks

Eligibility: Age-lower limit - 18 years-old <= Age-upper limit - Not applicable Gender - Male and Female Key inclusion criteria - 1. Age 18 years or older. 2. Patients receiving treatment for asthma with at least a medium dose of inhaled corticosteroids plus one or more additional long-term controller medications. 3. Fulfillment of 6 or more items of the Asano's diagnostic criteria for ABPA (J Allergy Clin Immunol. 2021;147:1261). 4. Serum Aspergillus fumigatus-specific IgE antibody level 0.35 UA/mL or higher. 5. At the time of initial onset or exacerbation of ABPA. 6. Written informed consent obtained after sufficient explanation, based on the participant's free will. 7. No exacerbation of ABPA within the past 12 months 8. Refractory ABPA score (Allergy. 2025;80:2531) is 1 or less. Key exclusion criteria - 1. Systemic corticosteroid administration within the past 1 month. 2. Treatment with immunosuppressive agents other than corticosteroids, antifungal agents (oral or intravenous), or biologics within the past 6 months. 3. Comorbidities precluding oral corticosteroid use (e.g., uncontrolled diabetes mellitus, glaucoma, active peptic ulcer disease, or active infection). 4. History of allergic reaction to mepolizumab (Nucala) or tezepelumab (Tezspire). 5. Currently undergoing treatment for malignancy, or history of treatment within the past year. 6. Severe cardiac disorders (e.g., heart failure, arrhythmia). 7. Any other condition deemed inappropriate by the principal investigator or study physician. Target Size - 20

Recruitment Status: Recruitment status - Preinitiation Date of protocol fixation - 2025 Year 10 Month 30 Day Date of IRB - 2025 Year 11 Month 05 Day Anticipated trial start date - 2025 Year 12 Month 01 Day Last follow-up date - 2030 Year 03 Month 31 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000068459

Disclaimer: Curated by HT Syndication.