Effect of Air Cleaner on the Indoor Allergen Sensitized Allergic Rhinitis Patients

Study Overview
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Brief Summary
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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

Detailed Description
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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.

Official Title
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Effect of Air Cleaner on the Indoor Allergen Sensitized Allergic Rhinitis Patients

Conditions
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Allergic Rhinitis

Intervention / Treatment
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* Device: PuriCare (HEPA Air Cleaner)
* Device: Mock device of PuriCare


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 19 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Aircleaner group<br>PuriCare (HEPA Air Cleaner) in active mode | Device: PuriCare (HEPA Air Cleaner)<br>* 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.<br>|
| Placebo Comparator: Control comparator<br>Mock device of PuriCare in active mode | Device: Mock device of PuriCare<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Daily symptom score of allergic rhinitis | Daily symptom score of allergic rhinitis: Rhinorrhea Nasal itchiness Sneezing Obstruction | 6 weeks | 
| Daily medication score of allergic rhinitis | Daily medication score of allergic rhinitis - Intranasal steroid Anti-histamine Leukotriene modifier | 6 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Visual analog scale of allergic rhinitis | 0 to 10 score of VAS | 6 weeks | 
| Quality of life score of allergic rhinitis | questionnaire | 6 weeks |