UMIN-CTR Clinical Trial

Basic information
Public title	Effect of air purification and humidification on asthma.
Acronym	Effect of air purification and humidification on asthma.
Scientific Title	Effect of air purification and humidification on asthma.
Scientific Title:Acronym	Effect of air purification and humidification on asthma.
Region	Japan

Condition
Condition	asthma
Classification by specialty	Pneumology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	We are conducting a questionnaire survey onasthma symptoms before and after using a humidifi ed air purifi er. by comparing the results,we will examine how streamer air purifi cationtechnology and humidifi cation technology aff ect the asthma symptoms. In addition, we will also acquire air quality data in the living environment of the subjects andexamine the relationship between the occurrence of asthma and asthma symptoms and airquality.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Association of asthmatic symptoms with use of the air purifi cation alone and with humidifi cation function.
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Cross-over
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -no one is blinded
Control	No treatment
Stratification	YES
Dynamic allocation	NO
Institution consideration	Institution is not considered as adjustment factor.
Blocking	YES
Concealment	No need to know

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Other
Interventions/Control_1	use of air purifi cation
Interventions/Control_2	use of air purifi cation and humidifi cation
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	12 years-old <=
Age-upper limit	120 years-old >
Gender	Male and Female
Key inclusion criteria	1)Males and females aged 12 years or older attime of informed consent. 2)Informed written consent from patients or authorized guardians. 3)Patients who have not used an air purifi er orhumidifi er in the last 3 months. 4)Patients who have been diagnosed with asthma and have visited a medical institution within one year.
Key exclusion criteria	1)Patients who have a history of other respiratory disease(lung cancer, interstitial pneumonia, etc.). 2)Smokers, households with smokers. 3)Patients who have serious or unstable liver,kidney, digestive, respiratory, cardiovascular (including ischemic heart disease), endocrine, neuro logical, psychological, immune or blood disorders that may aff ect the study.
Target sample size	30

Research contact person
Name of lead principal investigator	1st name Tomohiro Middle name Last name Yabu
Organization	DAIKIN (CHINA) INVESTMENT CO., LTD. OPEN INNOVATION LAB. SHENZHEN
Division name	R&D DEPT.
Zip code	518052
Address	5/F BLOCK 1, VISEEN BUSINESS PARK, 43 GAOXIN SOUTH RING ROAD, NANSHAN DISTRICT, SHENZHEN, CHINA
TEL	+86-188-2691-1831
Email	tomohiro.yabu@daikin.co.jp

Public contact
Name of contact person	1st name Tomohiro Middle name Last name Yabu
Organization	DAIKIN (CHINA) INVESTMENT CO., LTD. OPEN INNOVATION LAB. SHENZHEN
Division name	R&D DEPT.
Zip code	518052
Address	5/F BLOCK 1, VISEEN BUSINESS PARK, 43 GAOXIN SOUTH RING ROAD, NANSHAN DISTRICT, SHENZHEN, CHINA
TEL	+86-188-2691-1831
Homepage URL
Email	tomohiro.yabu@daikin.co.jp

Sponsor
Institute	DAIKIN (CHINA) INVESTMENT CO., LTD. OPEN INNOVATION LAB. SHENZHEN
Institute
Department

Funding Source
Organization	DAIKIN (CHINA) INVESTMENT CO., LTD. OPEN INNOVATION LAB. SHENZHEN
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Japan Conference of Clinical Research
Address	1-13-23, Minamiikebukuro, Toshima-ku, Tokyo
Tel	03-6868-7022
Email	jccr-info@jccr.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	2021 Year 11 Month 02 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	No longer recruiting
Date of protocol fixation	2021 Year 10 Month 21 Day
Date of IRB	2021 Year 10 Month 21 Day
Anticipated trial start date	2021 Year 11 Month 01 Day
Last follow-up date	2022 Year 02 Month 28 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded	2022 Year 12 Month 31 Day

Other
Other related information

Management information
Registered date	2021 Year 11 Month 02 Day
Last modified on	2021 Year 11 Month 24 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052456