UMIN-CTR Clinical Trial

Basic information
Public title	A pilot study for the association between home environment and allergic symptom
Acronym	home environment and allergic symptom
Scientific Title	A pilot study for the association between home environment and allergic symptom
Scientific Title:Acronym	home environment and allergic symptom
Region	Japan

Condition
Condition	asthma, asthmatic bronchitis, allergic rhinitis, allergic conjunctivitis, pollinosis
Classification by specialty	Clinical immunology Pediatrics Child
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To estimate the risk of count concentration of particulate matter to allergic symptom exacerbation
Basic objectives2	Others
Basic objectives -Others	To present basic data for the evaluation of efficacy of the environmental maintenance advice by the professional of the cleaning
Trial characteristics_1	Others
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	Allergy Control Score during the study (Time-series analysis)
Key secondary outcomes	Pollen counts in house dust Count concentration of particulate matter

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -but assessor(s) are blinded
Control	Placebo
Stratification	NO
Dynamic allocation	NO
Institution consideration	Institution is not considered as adjustment factor.
Blocking	NO
Concealment	No need to know

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Behavior,custom
Interventions/Control_1	Advise of environment maintainance by professional cleaners
Interventions/Control_2	Advise nothing
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	1 years-old <=
Age-upper limit	15 years-old >=
Gender	Male and Female
Key inclusion criteria	Live in Kyoto city (within about 20km from Kyoto University School of Public Health) or in Kizu city Mother of 1~15 years old children who has at least one of the followings asthma, asthmatic bronchitis, allergic rhinitis, allergic conjunctivitis, pollinosis
Key exclusion criteria	Spend less than 12 hours at home (allergic child)
Target sample size	40

Research contact person
Name of lead principal investigator	1st name Takeo Middle name Last name Nakayama
Organization	Kyoto University School of Public Health
Division name	Health Informatics
Zip code	660-0000
Address	Yoshida Konoe-cho, Sakyo, Kyoto
TEL	075-753-4488
Email	nakayama.takeo.4a@kyoto-u.ac.jp

Public contact
Name of contact person	1st name Kumiko Middle name Tsuji Last name Kanatani
Organization	Kyoto University School of Public Health
Division name	Health Informatics
Zip code	660-0000
Address	Yoshida Konoe-cho, Sakyo, Kyoto
TEL	080-6186-9375
Homepage URL
Email	kosa-office@umin.ac.jp

Sponsor
Institute	Kyoto University School of Public Health Departement of Health Informatics
Institute
Department

Funding Source
Organization	Duskin
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization	Japan

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

IRB Contact (For public release)
Organization	Kyoto University Graduate School
Address	Shogoin-Kawahara-cho 53, Sakyo, Kyoto
Tel	075-751-4182
Email	kanatani.kumiko.2r@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	京都大学大学院医学研究科 健康情報学（京都府）

Other administrative information
Date of disclosure of the study information	2016 Year 01 Month 04 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	Completed
Date of protocol fixation	2015 Year 03 Month 27 Day
Date of IRB	2016 Year 01 Month 15 Day
Anticipated trial start date	2015 Year 04 Month 01 Day
Last follow-up date	2018 Year 09 Month 12 Day
Date of closure to data entry	2018 Year 09 Month 13 Day
Date trial data considered complete	2018 Year 12 Month 31 Day
Date analysis concluded	2019 Year 03 Month 27 Day

Other
Other related information

Management information
Registered date	2016 Year 01 Month 04 Day
Last modified on	2021 Year 07 Month 09 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000019677