UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000031902 |
|---|---|
| Receipt number | R000036317 |
| Scientific Title | Effects of the use of air purifier on indoor environment and respiratory system among healthy adults. |
| Date of disclosure of the study information | 2018/04/01 |
| Last modified on | 2020/09/25 10:08:05 |
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Basic information
Public title
Effects of the use of air purifier on indoor environment and respiratory system among healthy adults.
Acronym
Effects of the use of air purifier on indoor environment and respiratory system among healthy adults.
Scientific Title
Effects of the use of air purifier on indoor environment and respiratory system among healthy adults.
Scientific Title:Acronym
Effects of the use of air purifier on indoor environment and respiratory system among healthy adults.
Region
| Japan |
Condition
Condition
N/A (healthy adults)
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Evaluate the effects of using an air purifier on indoor environment and respiratory system among healthy adults.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Pulmonary function, exhaled nitric oxide
Key secondary outcomes
Indoor concentrations of particulate matter, endotoxin and ozone.
Respiratory symptoms.
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Other |
Interventions/Control_1
With air purifier filter
Interventions/Control_2
Without Air purifier filter
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
| 30 | years-old | <= |
Age-upper limit
| 60 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
The household without using air purifier and with living room size of 6 to 12 tatami.
Key exclusion criteria
Smokers, households with smokers and persons with respiratory symptoms.
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Yoshiko |
| Middle name | |
| Last name | Yoda |
Organization
Hyogo College of Medicine
Division name
Public health
Zip code
663-8501
Address
1-1, Mukogawa-cho, Nishinomiya, Hyogo, Japan
TEL
0798-45-6566
yoda-y@hyo-med.ac.jp
Public contact
Name of contact person
| 1st name | Yoshiko |
| Middle name | |
| Last name | Yoda |
Organization
Hyogo College of Medicine
Division name
Public health
Zip code
663-8501
Address
1-1, Mukogawa-cho, Nishinomiya, Hyogo, Japan
TEL
0798-45-6566
Homepage URL
yoda-y@hyo-med.ac.jp
Sponsor or person
Institute
Hyogo College of Medicine
Institute
Department
Personal name
Funding Source
Organization
Japan Society for the Promotion of Science.
Grants-in-Aid for Scientific Research.
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
The Ethics Review Board of Hyogo College of Medicine
Address
1-1, Mukogawa-cho, Nishinomiya, Hyogo, Japan
Tel
0798-45-6066
rinri@hyo-med.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
Other administrative information
Date of disclosure of the study information
| 2018 | Year | 04 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
Number of participants that the trial has enrolled
32
Results
In the present study, air purification slightly improved indoor environments in ordinary homes but without reaching statistical significance. Additionally, we were not able to clearly show the effect of air purification on health improvement. However, we successfully demonstrated that air purification can reduce indoor PM2.5 concentrations in single-person households relative to outdoors.
Results date posted
| 2020 | Year | 09 | Month | 25 | Day |
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
Completed
Date of protocol fixation
| 2018 | Year | 01 | Month | 26 | Day |
Date of IRB
| 2018 | Year | 03 | Month | 27 | Day |
Anticipated trial start date
| 2018 | Year | 05 | Month | 01 | Day |
Last follow-up date
| 2020 | 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
| 2018 | Year | 03 | Month | 26 | Day |
Last modified on
| 2020 | Year | 09 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036317
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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