UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000025330 |
|---|---|
| Receipt number | R000029137 |
| Scientific Title | Study on indoor cleaning effect by air purifier and the influence on asthma |
| Date of disclosure of the study information | 2017/01/24 |
| Last modified on | 2023/06/26 13:46:48 |
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Basic information
Public title
Study on indoor cleaning effect by air purifier and the influence on asthma
Acronym
Study on indoor cleaning effect by air purifier and the influence on asthma
Scientific Title
Study on indoor cleaning effect by air purifier and the influence on asthma
Scientific Title:Acronym
Study on indoor cleaning effect by air purifier and the influence on asthma
Region
| Japan |
Condition
Condition
Bronchial asthma
Classification by specialty
| Pneumology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Investigate the effect on airborne dust, mite antigen and fungus by using an air purifier, and examine the effect on asthma patients
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
airborne dust, mite antigen, fungus, pulmonary function and asthma control of the patients
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Cluster
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
With air purifier
Interventions/Control_2
Without air purifier
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
| 20 | years-old | <= |
Age-upper limit
| 65 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Patients with bronchial asthma patients visiting Ikebukuro Otania clinic
Key exclusion criteria
(1) Complicated patients with other respiratory diseases (lung cancer, interstitial pneumonia etc).
(2) Persons who have severe liver, kidney, heart, or blood disease, other serious complications.
(3) Person who the doctor judged unsuitable as the subject.
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Yuki |
| Middle name | |
| Last name | Sumi |
Organization
Tokyo Medical and Dental University
Division name
Department of Clinical information Applied Sciences
Zip code
113-8519
Address
1-5-45 Yushima Bunkyo-ku Tokyo 113-8519 Japan
TEL
03-3813-6111
ysumi.pulm@tmd.ac.jp
Public contact
Name of contact person
| 1st name | Yuki |
| Middle name | |
| Last name | Sumi |
Organization
Tokyo Medical and Dental University
Division name
Department of Clinical information Applied Sciences
Zip code
113-8519
Address
1-5-45 Yushima Bunkyo-ku Tokyo 113-8519 Japan
TEL
03-3813-6111
Homepage URL
ysumi.pulm@tmd.ac.jp
Sponsor or person
Institute
Tokyo Medical and Dental University
Institute
Department
Personal name
Department of Clinical information Applied Sciences
Funding Source
Organization
Tokyo Medical and Dental University
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
Tokyo Medical and Dental University, Bioethics Research Center
Address
1-5-45 Yushima Bunkyo-ku Tokyo 113-8519 Japan
Tel
03-3813-4085, 4724
info.bec@tmd.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
池袋大谷クリニック (東京都)
Other administrative information
Date of disclosure of the study information
| 2017 | Year | 01 | Month | 24 | Day |
Related information
URL releasing protocol
under submitting
Publication of results
Partially published
Result
URL related to results and publications
under submitting
Number of participants that the trial has enrolled
50
Results
Air purifiers significantly decreased the levels of PM0.3, 2.5, and 5.0 in closed bedrooms. However, there were no significant differences in the number of cultured fungal colonies and mite antigen level. Spirometry, FOT and FeNO measurements results did not significantly too. Hence, the patients consistently had good asthma control. The intervention group experienced a significant improvement in the ACT score. The changes in treatment steps between the two groups did not significantly differ.
Results date posted
| 2023 | Year | 06 | Month | 26 | Day |
Results Delayed
| Delay expected |
Results Delay Reason
under submitting
Date of the first journal publication of results
Baseline Characteristics
Fifty patients with asthma who presented with house dust-specific IgE antibodies were randomly assigned to the intervention (n = 30) and control (n = 20) groups. The intervention group used air purifiers in their bedrooms.
Participant flow
Fifty patients with asthma who presented with house dust-specific IgE antibodies were randomly assigned to the intervention (n = 30) and control (n = 20) groups. The intervention group used air purifiers in their bedrooms. The two groups continuously received regular asthma treatments according to their medical condition. Air purifiers were provided to the intervention group and were regularly used all day in the bedrooms. Further, the control group received air purifiers after the study. The indoor environment was examined. Next, the asthma control status of the participants was evaluated by the asthma control test (ACT) before installing the air purifier (pre-installation) in January, February, and March 2017, approximately 2-3 months after the air purifier was provided in April, May, and June 2017 (post-installation 1), after 6 months in July, August, and September 2017 (post-installation 2), and after 1 year in February, March, and April 2018 (post-installation 3). At each time point, all evaluations were performed almost simultaneously (within 1 month) to prevent seasonal effects. At all-time points, clinical data including prescribed drugs, ACT, and pulmonary function tests (PFTs) results were obtained. At pre-installation, post- installation 1, and post-installation 2, the level of house dust mite (HDM) antigens in the bedroom was measured. Next, at pre-installation and post-installation 1, the level of PM and fungi was measured by examining the indoor environment.
Adverse events
None
Outcome measures
Indoor environment examination. (The levels of PM with diameters of 0.3 (PM0.3), 2.5 (PM2.5), and 5.0 (PM5.0). Dermatophagoides pteronyssinus and Dermatophagoides farina antigen levels. Cultured colony number of fungi).
Pulmonary function tests (Spirometry, exhaled nitric oxide measurement, forced oscillation technique)
Clinical information (Asthma control status assessed using ACT, Treatment steps evaluated based on the Global Initiative for Asthma, use of medications prescribed, number of common cold)
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Main results already published
Date of protocol fixation
| 2016 | Year | 12 | Month | 20 | Day |
Date of IRB
| 2017 | Year | 01 | Month | 24 | Day |
Anticipated trial start date
| 2017 | Year | 01 | Month | 25 | Day |
Last follow-up date
| 2018 | Year | 05 | 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
| 2016 | Year | 12 | Month | 19 | Day |
Last modified on
| 2023 | Year | 06 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029137
