UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000057551 |
|---|---|
| Receipt number | R000065756 |
| Scientific Title | Evaluation of the efficacy of immunotherapy with Aspergillus allergens |
| Date of disclosure of the study information | 2025/04/08 |
| Last modified on | 2025/04/08 12:41:28 |
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Basic information
Public title
Evaluation of the efficacy of immunotherapy with Aspergillus allergens
Acronym
Evaluation of the efficacy of immunotherapy with Aspergillus allergens
Scientific Title
Evaluation of the efficacy of immunotherapy with Aspergillus allergens
Scientific Title:Acronym
Evaluation of the efficacy of immunotherapy with Aspergillus allergens
Region
| Japan |
Condition
Condition
Aspergillus sensitized asthma
Classification by specialty
| Pneumology | Clinical immunology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Aspergillus-sensitized asthma accounts for more than 30% of adult asthma cases and is the most difficult airway disease to treat.
Unlike other fungi, Aspergillus is an airway decomposer, making environmental measures ineffective and more problematic in humid Japan. If allergen immunotherapy proves to be clinically useful and improves the airway fungal flora, it may become a less expensive curative treatment, leading to additional studies and guidelines in the future.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Comparison of Asthma Contorl Test scores before and 1 year after the start of allergen immunotherapy
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
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
All of the following must be met:
- Patients 18 years of age or older with a confirmed diagnosis of bronchial asthma and written consent
- Patients with an Aspergillus-specific IgE level (ImmunoCAP specific IgE test) of 0.70 UA/mL or higher (class 2 or higher)
- Aspergillus IgG negative, or Aspergillus sedimentation antibody negative (using the cutoff of Hamada Y, Futomi Y, Skiya K, and Taniguchi M, et al. Allergol Int. 2021) and do not meet the diagnostic criteria for allergic bronchopulmonary mycosis17)
-A history of at least 1 asthma exacerbation within the past 1 year or an ACT (Asthma Control Test) score of 20 or less
-Patients who are able to self-walk to the hospital on a regular basis for continued visits and plan to change their home environment
-Patients who plan to start allergen immunotherapy with Aspergillus allergen treatment extract in their usual insurance care
Key exclusion criteria
-Patients with insufficient diagnostic evidence of asthma (e.g., cough asthma, cough and breathlessness but lack of type 2 inflammation or lung function loss)
-COPD with uncertain diagnosis
-Patients receiving anticancer agents
-Patients receiving steroids or immunosuppressive agents other than for asthma/COPD treatment
-Patients without written consent
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | Sekiya |
| Middle name | |
| Last name | Kiyoshi |
Organization
National Hospital Organization Sagamihara National Hospital
Division name
Department of Allergy and Respiratory Medicine
Zip code
252-0392
Address
18-1 Sakuradai, Minami-ku, Sagamihara-shi, Kanagawa
TEL
042-742-8311
sekiya.kiyoshi.fe@mail.hosp.go.jp
Public contact
Name of contact person
| 1st name | Sekiya |
| Middle name | |
| Last name | Kiyoshi |
Organization
National Hospital Organization Sagamihara National Hospital
Division name
Department of Allergy and Respiratory Medicine
Zip code
252-0392
Address
18-1 Sakuradai, Minami-ku, Sagamihara-shi, Kanagawa
TEL
042-742-8311
Homepage URL
sekiya.kiyoshi.fe@mail.hosp.go.jp
Sponsor or person
Institute
National Hospital Organization Sagamihara National Hospital
Institute
Department
Personal name
Funding Source
Organization
Thermo Fisher Scientific
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
National Hospital Organization
Address
2-5-21, Higasigaoka, Meguroku, Tokyo, Japan
Tel
03-5712-5075
katsuno.takashi.jb@mail.hosp.go.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
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 04 | Month | 08 | 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
Open public recruiting
Date of protocol fixation
| 2025 | Year | 01 | Month | 07 | Day |
Date of IRB
| 2025 | Year | 02 | Month | 14 | Day |
Anticipated trial start date
| 2025 | Year | 02 | Month | 14 | Day |
Last follow-up date
| 2027 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
| 2027 | Year | 12 | Month | 31 | Day |
Other
Other related information
Observational studies (prospective cohort studies)
Management information
Registered date
| 2025 | Year | 04 | Month | 08 | Day |
Last modified on
| 2025 | Year | 04 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000065756
