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

NCT03313453 | Completed

• 1 other identifier: 4-2017-0588
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

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

Conditions

Allergic Rhinitis

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (2)

• Visual analog scale of allergic rhinitis

  6 weeks

• Quality of life score of allergic rhinitis

  6 weeks

Study Arms (2)

Aircleaner group

EXPERIMENTAL

PuriCare (HEPA Air Cleaner) in active mode

Device: PuriCare (HEPA Air Cleaner)

Control comparator

PLACEBO COMPARATOR

Mock device of PuriCare in active mode

Device: Mock device of PuriCare

Interventions

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.

Aircleaner group

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.

Control comparator

Eligibility Criteria

• Age: 19 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Yonsei University: lead

Study Sites (1)

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

Seoul, 03722, South Korea

Location

Related Publications (2)

• 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.

  PMID: 27723364 RESULT

• 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.

  PMID: 32734732 DERIVED

MeSH Terms

Conditions

Rhinitis, Allergic

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Allocation of intervention arm and scoring of symptom and medication scire will be performed by a designated unblinded member of the study staff (i.e. a qualified person who is independent of the protocol-defined study assessments). Once prepared, active air-cleaner and mock device will be identical in appearance. The blinding of all those involved in the evaluation of the study treatment (e.g. physician/nurse as well as the subject) shall be maintained at all times.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 29, 2017
• First Posted: October 18, 2017
• Study Start: August 16, 2017
• Primary Completion: December 22, 2017
• Study Completion: December 22, 2017
• Last Updated: February 13, 2018

Record last verified: 2018-02

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)