- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03313453
Effect of Air Cleaner on the Indoor Allergen Sensitized Allergic Rhinitis Patients
This study aimed to assess the impact of air cleanser on allergic rhinitis patients and indoor air quality. Air cleaners will be installed in the bedrooms and living rooms of the mite allergic rhinitis patients who aged 18-60 years.
Main parameters:
- Symptom medication score of allergic rhinitis
Supportive parameters:
- Visual analog scale of allergic rhinitis
- Quality of life score of allergic rhinitis
- Indoor air quality measurement
- Indoor allergen level measurement
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
The most important principle in the treatment of allergic diseases is to avoid or reduce exposure to the causative antigen. Causative agents that induce allergic diseases or exacerbate symptoms are classified into indoor and outdoor allergens. House dust mites and pet's hair are typical indoor antigens. Air pollution as well as allergens are important deterioration factors, and environmental management is essential for alleviating symptoms of allergic diseases. Therefore, we are about to evaluate the impact of the air cleaner to the allergic rhinitis patients.
A total of 45 patients will be enrolled in the study and a real air cleaner and a mock-up air cleaner will be randomly installed at ratio of 1: 1 to measure rhinitis symptoms and the changes in indoor air quality after 6 weeks of operation.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Seoul, Korea, Republic of, 03722
- Division of Allergy and Immunology Department of Internal Medicine, Yonsei University College of Medicine
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Adults between 19 and 65 years of age
- Allergy specialist diagnosis of Moderate to severe persistent allergic rhinitis
- Retrospective Rhinoconjunctivitis total symptom score higher than 7
- Allergy against house dust mite: Skin prick test, with a more than 3 mm wheal, Serum specific IgE higher than 0.35 kUA/L measured by ImmunoCAP
- Who can read and write Korean
- Participants those who voluntarily agreed to this study
Exclusion Criteria:
- Allergy against seasonal allergens (tree, grass, weed pollens)
- Patients with rhinitis due to other causes (drug induced rhinitis or infectious rhinitis etc.)
- Patients with severe anatomical abnormality that may cause nasal blockage such as nasal septum deviation or nasal polyps
- Chronic systemic corticosteroids (≥ 3 months continuous use in past 12 months)
- Participants planning to move or change residence within the study period.
- Staying away from the home continuously for more than 5 days in the study period.
- Having air cleaner previously
- Having indoor smoker
- If pregnancy test is positive or pregnancy is possible during study period.
- Any other reason the participants is deemed unsuitable for participation in clinical trials
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: Aircleaner group
PuriCare (HEPA Air Cleaner) in active mode
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The active comparator group is a group that uses machines that have the same functions as those on the market.
In intervention group, two air-cleaners will be activated, one in the living room (covers 91 m2) and the other in the bedroom (covers 58 m2).
The air cleaner will be operated continuously for 6 weeks.
Inside the air cleaner, a device for measuring the quality of the indoor air is built in.
It will be used to compare indoor air quality before and after air cleaner operation.
In order to maintain the double-blind setting, a label for 'prohibition of opening' will be attached to the joint of the outer case, and a sticker to cover the air quality measurement display part built in the air cleaner itself will be attached.
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Placebo Comparator: Control comparator
Mock device of PuriCare in active mode
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The Control group operates the air-cleaner with the same appearance as the experiment group.
However, all the filters including HEPA filter will not be inserted in this group (mockup devices).
Two mockup air-cleaners will be activated, one in the living room (covers 91 m2) and the other in the bedroom (covers 58 m2).
The mockup devices will be operated continuously for 6 weeks.
Same as active comparator group, a device for measuring the quality of the indoor air is built in the mockup air cleaner.
It will be used to compare indoor air quality before and after air cleaner operation.
In order to maintain the double-blind setting, a label for 'prohibition of opening' will be attached to the joint of the outer case, and a sticker to cover the air quality measurement display part built in the air cleaner itself will be attached.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Daily symptom score of allergic rhinitis
Time Frame: 6 weeks
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Daily symptom score of allergic rhinitis:
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6 weeks
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Daily medication score of allergic rhinitis
Time Frame: 6 weeks
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Daily medication score of allergic rhinitis - Intranasal steroid
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6 weeks
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Visual analog scale of allergic rhinitis
Time Frame: 6 weeks
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0 to 10 score of VAS
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6 weeks
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Quality of life score of allergic rhinitis
Time Frame: 6 weeks
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questionnaire
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6 weeks
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Collaborators and Investigators
Sponsor
Publications and helpful links
General Publications
- Park HK, Cheng KC, Tetteh AO, Hildemann LM, Nadeau KC. Effectiveness of air purifier on health outcomes and indoor particles in homes of children with allergic diseases in Fresno, California: A pilot study. J Asthma. 2017 May;54(4):341-346. doi: 10.1080/02770903.2016.1218011. Epub 2016 Oct 10.
- Park KH, Sim DW, Lee SC, Moon S, Choe E, Shin H, Kim SR, Lee JH, Park HH, Huh D, Park JW. Effects of Air Purifiers on Patients with Allergic Rhinitis: a Multicenter, Randomized, Double-Blind, and Placebo-Controlled Study. Yonsei Med J. 2020 Aug;61(8):689-697. doi: 10.3349/ymj.2020.61.8.689.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 4-2017-0588
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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