UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000061192 |
|---|---|
| Receipt number | R000069710 |
| Scientific Title | Effects of HEPA filters in air purifiers on asthma control: A prospective, double-blind, multicenter, randomized clinical trial |
| Date of disclosure of the study information | 2026/04/08 |
| Last modified on | 2026/04/08 07:18:33 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Effects of HEPA filters in air purifiers on asthma control: A prospective, double-blind, multicenter, randomized clinical trial
Acronym
Air purifiers and asthma control
Scientific Title
Effects of HEPA filters in air purifiers on asthma control: A prospective, double-blind, multicenter, randomized clinical trial
Scientific Title:Acronym
Air purifiers and asthma control
Region
| Japan |
Condition
Condition
asthma
Classification by specialty
| Pneumology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To clarify the relationship between asthma control and air quality in home environments by verifying the effectiveness of HEPA filters in air purifiers
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Difference in change in FEV1 between patients using air purifiers with HEPA filters and those using air purifiers without HEPA filters
Key secondary outcomes
(1) Difference in FVC change between patients using air purifiers with HEPA filters and those using air purifiers without HEPA filters.
(2) Difference in ACT between patients using air purifiers with HEPA filters and those using air purifiers without HEPA filters.
(3) Difference in CAAT between patients using air purifiers with HEPA filters and those using air purifiers without HEPA filters.
(4) Difference in FeNO between patients using air purifiers with HEPA filters and those using air purifiers without HEPA filters.
(5) Difference in change in allergens obtained from petri dishes placed in bedroom between patients using air purifiers with HEPA filters and those using air purifiers without HEPA filters.
(6) Difference in change in allergens obtained from air purifier filters between patients using air purifiers with HEPA filters and those using air purifiers without HEPA filters.
(7) Difference in microbial changes obtained from air purifier filters between patients using air purifiers with HEPA filters and those using air purifiers without HEPA filters.
(8) Difference in microbial changes obtained from skin swabs between patients using air purifiers with HEPA filters and those using air purifiers without HEPA filters.
(9) Differences in changes in air quality sensor data between patients using air purifiers with HEPA filters and those using air purifiers without HEPA filters.
(10) Differences in changes in Th2-related inflammatory markers in blood tests between patients using air purifiers with HEPA filters and those using air purifiers without HEPA filters.
(11) Differences in changes in air quality sensor data between patients using air purifiers with HEPA filters and those using air purifiers without HEPA filters due to differences in outdoor environmental data.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
(1) The group using air purifiers with HEPA filters
(2) Intervention period: 3 months
(3) Observation period: 1 month before the intervention period to assess indoor air quality without air purifiers
Interventions/Control_2
(1) The group using air purifiers without HEPA filters
(2) Intervention period: 3 months
(3) Observation period: 1 month before the intervention period to assess indoor air quality without air purifiers
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
(1) Details of drug therapy are not restricted.
(2) One or more specific IgE antibodies must be positive.
Key exclusion criteria
(1) Patients cannot install air purifier at home because of this large size or other reasons.
(2) Patients with cognitive impairment.
(3) Patients with chronic pneumothorax.
(4) Patients with unstable conditions due to a new pneumothorax occurring within the past 4 weeks.
(5) Patients with unstable conditions due to asthma exacerbation or airway infection within the past 4 weeks.
(6) Patients with pre-existing plans to be away from home for 7 days or more during the observation and intervention periods.
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Susumu |
| Middle name | |
| Last name | Sato |
Organization
Graduate School of Medicine, Kyoto University
Division name
Department of Respiratory Care and Sleep Control Medicine
Zip code
606-8507
Address
54 Shogoin Kawahara-cho, Sakyo-ku, Kyoto
TEL
075-751-3852
ssato@kuhp.kyoto-u.ac.jp
Public contact
Name of contact person
| 1st name | Satoshi |
| Middle name | |
| Last name | Hamada |
Organization
Graduate School of Medicine, Kyoto University
Division name
Department of Advanced Medicine for Respiratory Failure
Zip code
606-8507
Address
54 Shogoin Kawahara-cho, Sakyo-ku, Kyoto
TEL
075-366-7689
Homepage URL
sh1124@kuhp.kyoto-u.ac.jp
Sponsor or person
Institute
Department of Advanced Medicine for Respiratory Failure, Graduate School of Medicine, Kyoto University
Institute
Department
Personal name
Satoshi Hamada
Funding Source
Organization
Daikin Industries Limited
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kyoto University Graduate School and Faculty of Medicine, Ethics Committee
Address
53 Shogoin-kawahara-cho, Sakyo-ku, Kyoto
Tel
075-366-7618
ethcom@kuhp.kyoto-u.ac.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
京都大学医学部附属病院（京都府）、綾部市立病院（京都府）、独立行政法人国立病院機構 京都医療センター（京都府）、大阪府済生会 中津病院（大阪府）、大阪府済生会 野江病院（大阪府）
Other administrative information
Date of disclosure of the study information
| 2026 | 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
Preinitiation
Date of protocol fixation
| 2026 | Year | 04 | Month | 08 | Day |
Date of IRB
Anticipated trial start date
| 2026 | Year | 09 | Month | 01 | 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
Other
Other related information
Management information
Registered date
| 2026 | Year | 04 | Month | 08 | Day |
Last modified on
| 2026 | 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=R000069710
