UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000045958
Receipt number R000052456
Scientific Title Effect of air purification and humidification on asthma.
Date of disclosure of the study information 2021/11/02
Last modified on 2021/11/24 14:36:35

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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 or person

Institute

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

Institute

Department

Personal name



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

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052456