UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000035477 |
|---|---|
| Receipt number | R000040418 |
| Scientific Title | International Survey of Effects of Social and Environmental Factors on Respiratory Function |
| Date of disclosure of the study information | 2019/01/21 |
| Last modified on | 2025/01/26 16:49:33 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
International Survey of Effects of Social and Environmental Factors on Respiratory Function
Acronym
International Survey of Effects of Social and Environmental Factors on Respiratory Function
Scientific Title
International Survey of Effects of Social and Environmental Factors on Respiratory Function
Scientific Title:Acronym
International Survey of Effects of Social and Environmental Factors on Respiratory Function
Region
| Asia(except Japan) |
Condition
Condition
Respiratory Function
Classification by specialty
| Pneumology | Adult | Child |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
1. Investigating the effects of social factors such as job and environmental factors such as air pollutants on respiratory function in South Aisa
2. Evaluating the efficacy of mask for preventing the harmful influence.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Respiratory function
Key secondary outcomes
Fractional exhaled nitric oxide(FeNO), Health status related to air pollution
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Behavior,custom |
Interventions/Control_1
Using disposable mask
Interventions/Control_2
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Residents in Kolkata or the rural areas, West Bengal, India
Residents in Khulna, Bangladesh
Key exclusion criteria
Smoker
Having a serious past medical history
Having a disease
Having a serious injury
Taking currently medication
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Tomohiro |
| Middle name | |
| Last name | Umemura |
Organization
Aichi Medical University
Division name
School of Medicine
Zip code
480-1185
Address
1-1 Yazakokarimata, Nagakute, Aichi, Japan
TEL
0561-62-3311
ume@aichi-med-u.ac.jp
Public contact
Name of contact person
| 1st name | Tomohiro |
| Middle name | |
| Last name | Umemura |
Organization
Aichi Medical University
Division name
School of Medicine
Zip code
480-1185
Address
1-1 Yazakokarimata, Nagakute, Aichi, Japan
TEL
0561-62-3311
Homepage URL
ume@aichi-med-u.ac.jp
Sponsor or person
Institute
Aichi Medical University
Institute
Department
Personal name
Tomohiro Umemura
Funding Source
Organization
Japan Society for the Promotion of Science
The Asahi Glass Foundation
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
Ethical Committee of Aichi Medical University
Address
1-1 Yazakokarimata, Nagakute, Aichi, Japan
Tel
0561-62-3311
amu_ethics@aichi-med-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
Other administrative information
Date of disclosure of the study information
| 2019 | Year | 01 | Month | 21 | 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
| Delay expected |
Results Delay Reason
Because of the COVID-19 epidemic, foreign activities have been restricted.
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
Suspended
Date of protocol fixation
| 2018 | Year | 12 | Month | 19 | Day |
Date of IRB
| 2019 | Year | 01 | Month | 07 | Day |
Anticipated trial start date
| 2019 | Year | 01 | Month | 21 | Day |
Last follow-up date
| 2023 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
The aim of this study was to have individuals without a habit of wearing masks adopt mask-wearing and to evaluate its effects. However, after the baseline survey was completed and just before the mask-wearing phase, the COVID-19 pandemic emerged. Consequently, mask-wearing habits became widespread in the area, altering the local lifestyle compared to the pre-pandemic period. Therefore, we are currently suspending the intervention. Given these circumstances, we are moving towards either modifying or discontinuing the intervention for preventing air and indoor pollution (mask-wearing), and limiting our analysis to the comparison between the dry and rainy seasons of the baseline period.
Management information
Registered date
| 2019 | Year | 01 | Month | 07 | Day |
Last modified on
| 2025 | Year | 01 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040418
