UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000053190 |
|---|---|
| Receipt number | R000060687 |
| Scientific Title | Examination for the effects of air purifiers on allergic rhinitis symptoms |
| Date of disclosure of the study information | 2023/12/25 |
| Last modified on | 2023/12/22 07:00:26 |
* 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
Examination for the effects of air purifiers on allergic rhinitis symptoms
Acronym
Examination for the effects of air purifiers
Scientific Title
Examination for the effects of air purifiers on allergic rhinitis symptoms
Scientific Title:Acronym
Examination for the effects of air purifiers
Region
| Japan |
Condition
Condition
allergic rhinitis
Classification by specialty
| Medicine in general | Clinical immunology | Oto-rhino-laryngology |
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To verify whether the use of air purifiers is useful for alleviating allergic symptoms in patients with allergic rhinitis.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
If there is any improvement in the Japan Allergic Rhinitis Standard Quality of Life Questionnaire (JRQLQ): The JRQLQ includes questions about six areas: daily life, outdoor life, social life, sleep, physical, and mental health. The total score of each score is the primary outcome, and evaluate whether the score is decrease after using the purifier compared to before.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
Ten air purifiers A and B are randomly prepared with or without filters.
During the seven-week test period, air purifier A is operated for the first two weeks, followed by a three-week wash out period, and air purifier B is operated for the remaining two weeks.
Intervention 1 is first two weeks.
Interventions/Control_2
Ten air purifiers A and B are randomly prepared with or without filters.
During the seven-week test period, air purifier A is operated for the first two weeks, followed by a three-week wash out period, and air purifier B is operated for the remaining two weeks.
Intervention 2 is last two weeks.
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. Allergic rhinitis patients attending the Department of Otorhinolaryngology/Head and Neck Surgery, Kyoto University Hospital
2. Persons who are 18 years of age or older at the time of obtaining consent
3. Persons with specific IgE antibodies to class 3 or higher for leopard mites and Japanese cedar
4. Those who have nasal congestion, nasal discharge, sneezing, or any nasal symptom score of 2+ or higher and have persisted for more than 1 week.
5. Persons who have an air purifier, mobile router, environmental sensor, and petri dish installed in the room where they sleep and are able to operate them at night while sleeping.
Key exclusion criteria
1. Those who have participated in other clinical research/trials involving intervention within 3 months before consent was obtained.
2. People who are already using air purifiers at home
3. Have a history of substance abuse (drugs or alcohol) within the past 5 years or other factors (such as serious mental conditions) that may limit the ability to comply with the study procedures.
4. Those who have purchased a futon or bed more than half a year ago
5. Those who do not stay overnight for one week or more during the exam.
6. Persons using allergy-proof bedding
7. Any other person whose participation in this study is considered inappropriate according to the judgment of the physician participating in the study.
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Mami |
| Middle name | |
| Last name | Matsunaga |
Organization
Department of Otolaryngology, Head and Neck Surgery
Kyoto University
Division name
Department of Otolaryngology, Head and Neck Surgery
Zip code
6068507
Address
54 Shogoin Kawahara-cho, Sakyo-ku, Kyoto
TEL
0757513346
m_matsunaga@ent.kuhp.kyoto-u.ac.jp
Public contact
Name of contact person
| 1st name | Mami |
| Middle name | |
| Last name | Matsunaga |
Organization
Kyoto university
Division name
Center for Allergy, Kyoto University Hospital
Zip code
6068507
Address
54 Shogoin Kawahara-cho, Sakyo-ku, Kyoto
TEL
0757513346
Homepage URL
m_matsunaga@ent.kuhp.kyoto-u.ac.jp
Sponsor or person
Institute
Kyoto university
Institute
Department
Personal name
Mami Matsunaga
Funding Source
Organization
Daikin corporation
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kyoto university
Address
54 Shogoin Kawahara-cho, Sakyo-ku, Kyoto
Tel
0757534680
ethcom@kuhp.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
Other administrative information
Date of disclosure of the study information
| 2023 | Year | 12 | Month | 25 | 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
Enrolling by invitation
Date of protocol fixation
| 2023 | Year | 12 | Month | 20 | Day |
Date of IRB
| 2023 | Year | 12 | Month | 20 | Day |
Anticipated trial start date
| 2024 | Year | 01 | Month | 04 | Day |
Last follow-up date
| 2024 | Year | 12 | 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
| 2023 | Year | 12 | Month | 22 | Day |
Last modified on
| 2023 | Year | 12 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000060687
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
