UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000059913 |
|---|---|
| Receipt number | R000068398 |
| Scientific Title | Efficacy and safety of short-course corticosteroid treatment with or without biologics for allergic bronchopulmonary aspergillosis complicating asthma-1 |
| Date of disclosure of the study information | 2025/12/01 |
| Last modified on | 2025/11/28 13:40:50 |
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Basic information
Public title
Efficacy and safety of short-course corticosteroid treatment with biologics for difficult-to-treat allergic bronchopulmonary aspergillosis complicating asthma
Acronym
CORTICOBIO-ABPA
Scientific Title
Efficacy and safety of short-course corticosteroid treatment with or without biologics for allergic bronchopulmonary aspergillosis complicating asthma-1
Scientific Title:Acronym
CORTICOBIO-ABPA
Region
| Japan |
Condition
Condition
Allergic bronchopulmonary aspergillosis complicating asthma
Classification by specialty
| Pneumology | Clinical immunology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The standard treatment for acute allergic bronchopulmonary aspergillosis (ABPA) consists of 4-6 months of oral corticosteroid therapy. Although the initial therapeutic response is generally favorable, tapering or discontinuation of treatment is often difficult, resulting in high treatment failure rate. 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 therapy combined with biologics (anti-IL-5 antibody/anti-TSLP antibody) in refractory ABPA cases through a multicenter randomized controlled trial.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
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).
Key secondary outcomes
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
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
YES
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Central registration
Intervention
No. of arms
3
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Standard corticosteroid treatment
Oral prednisolone administration for 16 weeks.
Interventions/Control_2
Short-course corticosteroid treatment + anti-IL-5 antibody
Oral prednisolone administration for 10 weeks, combined with mepolizumab (100 mg subcutaneous injection every 4 weeks, administered three times at weeks 2, 6, and 10).
Interventions/Control_3
Short-course corticosteroid treatment + anti-TSLP antibody
Oral prednisolone administration for 10 weeks, combined with tezepelumab (210 mg subcutaneous injection every 4 weeks, administered three times at weeks 2, 6, and 10).
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
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. 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.
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 sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Koichiro |
| Middle name | |
| Last name | Asano |
Organization
Tokai University School of Medicine
Division name
Division of Pulmonary Medicine, Department of Medicine
Zip code
2591193
Address
143 Shimokasuya, Isehara Kanagawa 2591193, Japan
TEL
81463931121
koasano@gmail.com
Public contact
Name of contact person
| 1st name | Koichiro |
| Middle name | |
| Last name | Asano |
Organization
Tokai University School of Medicine
Division name
Division of Pulmonary Medicine, Department of Medicine
Zip code
2591193
Address
143 Shimokasuya, Isehara Kanagawa 2591193, Japan
TEL
81463931121
Homepage URL
koasano@gmail.com
Sponsor or person
Institute
Tokai University
Institute
Department
Personal name
Koichiro Asano
Funding Source
Organization
Japan Agency for Medical Research and Development
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
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
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Tokai University Institutional Review Board for Clinical Research
Address
143 Shimokasuya, Isehara Kanagawa 2591193, Japan
Tel
81463931121
tokai-rinsho@ml.tokai-u.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
東海大学医学部付属病院（神奈川県）、大阪大学医学部（大阪府）、慶應義塾大学病院（東京都）、秋田大学医学部附属病院（秋田県）、浜松医科大学医学部附属病院（静岡県）、北里大学北里研究所病院（東京都）、磐田市立総合病院（静岡県）、聖隷三方原病院（静岡県）、さいたま市立病院（埼玉県）、国立病院機構相模原病院（神奈川県）、国立病院機構福岡病院（福岡県）、国家公務員共済組合連合会立川病院（東京都）
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 12 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
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 |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2025 | Year | 11 | Month | 28 | Day |
Last modified on
| 2025 | Year | 11 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000068398
