Allergic bronchopulmonary aspergillosis complicating asthma
Conditions
Interventions
Standard corticosteroid treatment Oral prednisolone administration for 16 weeks.
Short-course corticosteroid treatment + anti-IL-5 antibody Oral prednisolone administration for 10 weeks, combine
Sponsors
Tokai University
Osaka University Faculty of Medicine, Keio University Hospital, Akita University Hospital, Hamamatsu University School of Medicine, University Hospital, Kitasato Institute Hospital, Iwata City Hospital, Seirei Mikatahara General Hospital, Saitama City Hospital, National Hospital Organization Sagamihara Hospital, National Hospital Organization Fukuoka Hospital, Tachikawa Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
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. Refractory ABPA score (Allergy. 2025;80:2531) is 2 or more. Note: If enrollment in Refractory Group 1 fulfilling criteria 1-7 is insufficient, patients who also meet criteria 1-6 and experience an exacerbation of ABPA within six months after standard corticosteroid therapy may be enrolled as Refractory Group 2, with up to five cases permitted in each group. Randomization will be stratified by Refractory Group 1 and Refractory Group 2.
Exclusion criteria
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Time to treatment failure within 40 weeks after initiation of therapy (patients receiving anti-IL-5 antibody or anti-TSLP antibody will be analyzed collectively as the short-course corticosteroid with biologics treatment group). | — |
Secondary
| Measure | Time frame |
|---|---|
| Key Secondary Endpoints 1. Time to exacerbation of ABPA within 92 weeks after initiation of therapy 2. Safety within 92 weeks after initiation of therapy Other Secondary Endpoints 1. Longitudinal changes in asthma control (ACQ) 2. Changes in asthma-related quality of life (miniAQLQ) 3. Longitudinal changes in serum total IgE levels, peripheral blood eosinophil counts, and Aspergillus-specific IgE and IgG 4. Time to improvement in chest imaging findings 5. Changes in pulmonary function (FEV1, FeNO) 6. Post-treatment exacerbation of ABPA within 1.5 years after completion of therapy and risk factors associated with exacerbation 7. Time to treatment failure within 40 weeks: comparison between patients receiving anti-IL-5 antibody and those receiving anti-TSLP antibody Exploratory Secondary Endpoints 1. Changes in the plasma proteome before and after treatment and their association with post-treatment ABPA exacerbation 2. Changes in peripheral blood immune cell populations before and after treatment and their association with post-treatment ABPA exacerbation | — |
Countries
Japan
Contacts
Public ContactKoichiro Asano
Tokai University School of Medicine Division of Pulmonary Medicine, Department of Medicine
Outcome results
None listed