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

Allergic Rhinitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03313453
• Other study ID #: 4-2017-0588
• Status: Completed
• Phase: N/A
• First received: September 29, 2017
• Last updated: February 12, 2018
• Start date: August 16, 2017
• Est. completion date: December 22, 2017

Study information

• Verified date: February 2018
• Source: Yonsei University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 44
• Est. completion date: December 22, 2017
• Est. primary completion date: December 22, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Allergic Rhinitis
• Rhinitis
• Rhinitis, Allergic

Intervention

Device:
• PuriCare (HEPA Air Cleaner)
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.
• Mock device of PuriCare
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.

Locations

Country	Name	City	State
Korea, Republic of	Division of Allergy and Immunology Department of Internal Medicine, Yonsei University College of Medicine	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Yonsei University

Country where clinical trial is conducted

Korea, Republic of, 

References & Publications (1)

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: 10.1080/0 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Daily symptom score of allergic rhinitis	Daily symptom score of allergic rhinitis: Rhinorrhea; Nasal itchiness; Sneezing; Obstruction	6 weeks
Primary	Daily medication score of allergic rhinitis	Daily medication score of allergic rhinitis - Intranasal steroid; Anti-histamine; Leukotriene modifier	6 weeks
Secondary	Visual analog scale of allergic rhinitis	0 to 10 score of VAS	6 weeks
Secondary	Quality of life score of allergic rhinitis	questionnaire	6 weeks