UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000048857 |
|---|---|
| Receipt number | R000055411 |
| Scientific Title | Effects of integrated environmental intervention on prevention of worsening of allergic bronchopulmonary aspergillosis |
| Date of disclosure of the study information | 2022/09/11 |
| Last modified on | 2023/09/11 05:54:01 |
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Basic information
Public title
Effects of integrated environmental intervention on prevention of worsening of allergic bronchopulmonary aspergillosis
Acronym
ENVIPAS study
Scientific Title
Effects of integrated environmental intervention on prevention of worsening of allergic bronchopulmonary aspergillosis
Scientific Title:Acronym
ENVIPAS study
Region
| Japan |
Condition
Condition
Allergic bronchopulmonary aspergillosis
Classification by specialty
| Pneumology | Clinical immunology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To test whether integrative environmental interventions improve patient and environmental outcomes
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Parallel-group comparative study: comparison of maximum total serum IgE levels in the first year after intervention in the control environmental intervention group and the integrated environmental intervention group
Before-and-after study: comparison of maximum serum total IgE levels in the first year after intervention with control and integrated environmental interventions
Key secondary outcomes
Comparison of maximum serum Aspergillus-specific IgE antibody titers in the first year after intervention
Rate of change in serum total IgE level and serum Aspergillus-specific IgE antibody level beforeand after 1 year of intervention
Changes in serum Aspergillus-specific IgG antibody titers before and after intervention
Change in ABPM relapse rate before and after intervention
Change in asthma exacerbation rate before and after intervention
Changes in room temperature and humidity before and after intervention
Changes in indoor fungal load before and after intervention
Changes in mite antigen content in house dust before and after intervention
(exploratory outcomes)
Changes in peripheral blood eosinophil counts
Changes in serum titers of IgE antibody to fungi other than Aspergillus
Changes in FeNO
Changes in miniAQLQ, ACQ5, CAT
Changes in radiographic findings in chest
Changes in VOC in residences
Changes in fungal species in residences
Changes in bacterial load and species in residences
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -but assessor(s) are blinded
Control
Active
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Other |
Interventions/Control_1
Integrated environmental intervention group
1. Room cleaning by professional cleaners
2. Cleaning guidance by a professional cleaning company
3. Air conditioner cleaning by professional cleaners
4. Regular recommendations for self-cleaning of the indoor environment
5. Indoor installation of air purifiers
Interventions/Control_2
Control environmental intervention group
1. Room cleaning by professional cleaners
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. Those who meet 5 points or more in the diagnostic criteria for allergic bronchopulmonary mycosis (2019, J Allergy Clin Immunol. 2021;147:1261)
2. Subjects with a total serum IgE level of 417 IU/mL or higher or an Aspergillus-specific IgE level of 1.0 UA/mL or higher
3. Subjects who have provided have obtained written consent of their own free will.
Key exclusion criteria
1. Patients with Aspergillus-related lung disease other than ABPM (chronic pulmonary aspergillosis, etc.)
2. Patients with with cystic fibrosis
3. Those who plan to move from their current residence within one year of the scheduled start date of the research
4. Persons whose current residence is less than 1 year old from the scheduled start date of research
5. Those who do not have an air conditioner installed in the living room or the bedroom in their current residence.
6. The air conditioner in the living room and the bedroom in the current residence has been purchased or cleaned by a professional within one year of the scheduled start date of research.
7. Complete remission in the past 3 years; no treatment with oral steroids, antifungal drugs, or antibody drugs, no clinical symptoms or no abnormalities in the laboratory and radiographic tests
8. Patients who have received medium to high-dose oral steroid therapy (more than 10 mg/day equivalent to PSL for 14 days or more) within the past month
9. Patients who have newly started antifungal drug or biologics within the past 6 months
Target sample size
130
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
259-1193
Address
Shimokasuya 143, Isehara, Kanagawa, Japan
TEL
0463-93-1121
ko-asano@tokai-u.jp
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
259-1193
Address
Shimokasuya 143, Isehara, Kanagawa2591193, Japan
TEL
0463-93-1121
Homepage URL
ko-asano@tokai-u.jp
Sponsor or person
Institute
Japan Agency for Medical Research and Development
Institute
Department
Personal name
Funding Source
Organization
Japan Agency for Medical Research and Development
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Institutional Review Board for Clinical Research, Tokai University
Address
Shimokasuya 143, Isehara, Kanagawa2591193, Japan
Tel
0463-93-1121
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）、国立病院機構相模原病院（神奈川県）、国立病院機構東京病院（東京都）、埼玉県立循環器・呼吸器病センター（埼玉県）、慶應義塾大学病院（東京都）、藤田医科大学ばんたね病院（愛知県）、浜松医科大学病院（静岡県）、国家公務員共済組合連合会立川病院（東京都）、さいたま市立病院（埼玉県）、北里研究所病院（東京都）、浜松ろうさい病院（静岡県）、聖隷浜松病院（静岡県）、聖隷三方原病院（静岡県）、磐田市立総合病院（静岡県）、藤枝市立総合病院（静岡県）、富山県立中央病院（富山県）、加古川中央市民病院（兵庫県）、山口大学医学部附属病院（山口県）、さいたま赤十字病院（埼玉県）、埼玉医科大学病院（埼玉県）、三菱京都病院（京都府）、北海道大学病院（北海道）、奈良県立医科大学（奈良県）、順天堂大学医学部附属順天堂医院（東京都）、東京医科歯科大学大学院医歯学総合研究所（東京都）、済生会宇都宮病院（栃木県）、防衛医科大学校（埼玉県）、独立行政法人国立病院機構東名古屋病院（愛知県）、名古屋大学医学部附属病院（愛知県）、公立陶生病院（愛知県）、鳥取大学医学部附属病院（鳥取県）、KKR札幌医療センター（北海道）、天理よろづ相談所病院（奈良県）、国立病院機構災害医療センター（東京都）、神奈川県立循環器呼吸器病センター（神奈川県）、自治医科大学（栃木県）、国立大学法人信州大学（長野県）、奈良医療センター（奈良県）、佐賀大学医学部附属病院（佐賀県）、独立行政法人国立病院機構金沢医療センター（石川県）、新潟大学大学院医歯学総合研究科（新潟県）、福島県立医科大学（福島県）、鹿児島大学病院（鹿児島県）、独立行政法人大阪刀根山医療センター（大阪府）、秋田大学大学院医学系研究科（秋田県）、国立病院機構福岡病院（福岡県）、京都大学大学院（京都府）、高知大学医学部附属病院（高知県）、東邦大学医療センター大橋病院（東京都）、長崎大学病院（長崎県）、豊田地域医療センター（愛知県）、坂総合病院（宮城県）
Other administrative information
Date of disclosure of the study information
| 2022 | Year | 09 | Month | 11 | 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
Enrolling by invitation
Date of protocol fixation
| 2022 | Year | 07 | Month | 15 | Day |
Date of IRB
| 2022 | Year | 07 | Month | 26 | Day |
Anticipated trial start date
| 2022 | Year | 09 | Month | 15 | Day |
Last follow-up date
| 2026 | Year | 09 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2022 | Year | 09 | Month | 05 | Day |
Last modified on
| 2023 | Year | 09 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000055411
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
