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Completed

NCT Number: 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

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Key information

Conditions

Allergic Rhinitis Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Nose Diseases Otorhinolaryngologic Diseases Respiratory Hypersensitivity Respiratory Tract Diseases Rhinitis Rhinitis, Allergic

Age range

19 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Division of Allergy and Immunology Department of Internal Medicine, Yonsei University College of Medicine

Seoul, 03722, South Korea

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

PuriCare (HEPA Air Cleaner)

Device

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

Device

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.

Primary outcomes

  1. Daily symptom score of allergic rhinitis

    Time frame: 6 weeks

    Daily symptom score of allergic rhinitis:

    • Rhinorrhea
    • Nasal itchiness
    • Sneezing
    • Obstruction

  2. Daily medication score of allergic rhinitis

    Time frame: 6 weeks

    Daily medication score of allergic rhinitis - Intranasal steroid

    • Anti-histamine
    • Leukotriene modifier

Secondary outcomes

  1. Visual analog scale of allergic rhinitis

    Time frame: 6 weeks

    0 to 10 score of VAS

  2. Quality of life score of allergic rhinitis

    Time frame: 6 weeks

    questionnaire

Sponsors and collaborators

Lead sponsor

Yonsei University

Other

Registry information

Important dates

Study start
2017
Primary completion
2017
Study completion
2017
First posted
Oct 18, 2017
Registry last updated
Feb 13, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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