UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000057550 |
|---|---|
| Receipt number | R000063736 |
| Scientific Title | Increasing number of Aspergillus fumigatus sensitized asthma or COPD patients, National survey |
| Date of disclosure of the study information | 2025/04/08 |
| Last modified on | 2025/04/08 12:08:46 |
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Basic information
Public title
Increasing number of Aspergillus fumigatus sensitized asthma or COPD patients, National survey
Acronym
Increasing number of Aspergillus fumigatus sensitized asthma or COPD patients, National survey
Scientific Title
Increasing number of Aspergillus fumigatus sensitized asthma or COPD patients, National survey
Scientific Title:Acronym
Increasing number of Aspergillus fumigatus sensitized asthma or COPD patients, National survey
Region
| Japan |
Condition
Condition
bronchial asthma, COPD
Classification by specialty
| Clinical immunology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Aspergillus fumigatus is a unique allergen that causes airway destruction, airway decompensation, and strong eosinophilic inflammation and is strongly associated with asthma and COPD refractoriness, and has a higher sensitization rate in adults than in children, especially in elderly patients with asthma. However, the sensitization status in asthma and COPD patients has rarely been studied. In a survey conducted by the National Hospital Organization Sagamihara Hospital, it was reported that Aspergillus-sensitized asthma has increased rapidly over the past 20 years, and that the use of high-dose inhaled steroids, advanced age, and decreased lung function are significant factors. Therefore, we aimed to clarify the current Aspergillus sensitization status and its risk background in adult asthma/COPD patients through a large-scale nationwide survey.
Basic objectives2
Others
Basic objectives -Others
Aspergillus fumigatus is a unique allergen that causes airway destruction, airway decompensation, and strong eosinophilic inflammation and is strongly associated with asthma and COPD refractoriness, and has a higher sensitization rate in adults than in children, especially in elderly patients with asthma. However, the sensitization status in asthma and COPD patients has rarely been studied. In a survey conducted by the National Hospital Organization Sagamihara Hospital, it was reported that Aspergillus-sensitized asthma has increased rapidly over the past 20 years, and that the use of high-dose inhaled steroids, advanced age, and decreased lung function are significant factors. Therefore, we aimed to clarify the current Aspergillus sensitization status and its risk background in adult asthma/COPD patients through a large-scale nationwide survey.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Positivity of serum Aspergillus and its specific allergen component, Asp f 1 specific IgE antibodies, etc.
Regional differences.
Aspergillus, and other allergen positivity in relation to background of asthma or COPD patients, espeicially lung function, severity of disease, and inhaled steroid medications.
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
The diagnostic criteria for asthma and COPD shall be patients clinically diagnosed by a respiratory physician, with or without complications.
Written consent for the study will be obtained for patients.
Patients who have undergone the specified IgE test within one year of consent and the results are obtained within the study period will be enrolled. However, some laboratory results (blood tests, lung function, etc.) within one year prior to the start of the study may also be substituted.
Key exclusion criteria
Patients with insufficient diagnostic evidence of asthma (e.g., coughing asthma, cough and breathlessness but poor type 2 inflammation and pulmonary hypofunction).
COPD with uncertain diagnosis.
Patients receiving steroids or immunosuppressive drugs other than for anticancer or asthma/COPD treatment purposes.
Patients who cannot give written consent.
Patients who cannot give consent for IgE blood collection.
Target sample size
1500
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 study
Target enrollment: 1000 adults with asthma and 500 adults with COPD
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=R000063736
