UMIN-CTR Clinical Trial

Recruitment status Completed
Unique ID issued by UMIN UMIN000031902
Receipt No. 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 (Ver. 9)

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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
Email 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
Email yoda-y@hyo-med.ac.jp

Sponsor
Institute Hyogo College of Medicine
Institute
Department

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
Email 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000036317