Clinical trial NCT03313453: Effect of Air Cleaner on the Indoor Allergen Sensitized Allergic Rhinitis Patients
Official title: Effect of Air Cleaner on the Indoor Allergen Sensitized Allergic Rhinitis Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Allergic Rhinitis
Lead sponsor: Yonsei University
Sponsor class: OTHER
First posted: 2017-10-18
Enrollment: 44
Sex: ALL
Minimum age (years): 19
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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

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.

Eligibility criteria: 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

Primary outcomes:
measure: Daily symptom score of allergic rhinitis
timeFrame: 6 weeks
measure: Daily medication score of allergic rhinitis
timeFrame: 6 weeks
Secondary outcomes:
measure: Visual analog scale of allergic rhinitis
timeFrame: 6 weeks
measure: Quality of life score of allergic rhinitis
timeFrame: 6 weeks
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Division of Allergy and Immunology Department of Internal Medicine, Yonsei University College of Medicine
Study officials:
References:
citation: 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.
citation: 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.