search
Back to results

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

Primary Purpose

Allergic Rhinitis

Status
Completed
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
PuriCare (HEPA Air Cleaner)
Mock device of PuriCare
Sponsored by
Yonsei University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Allergic Rhinitis

Eligibility Criteria

19 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Aircleaner group

Control comparator

Arm Description

PuriCare (HEPA Air Cleaner) in active mode

Mock device of PuriCare in active mode

Outcomes

Primary Outcome Measures

Daily symptom score of allergic rhinitis
Daily symptom score of allergic rhinitis: Rhinorrhea Nasal itchiness Sneezing Obstruction
Daily medication score of allergic rhinitis
Daily medication score of allergic rhinitis - Intranasal steroid Anti-histamine Leukotriene modifier

Secondary Outcome Measures

Visual analog scale of allergic rhinitis
0 to 10 score of VAS
Quality of life score of allergic rhinitis
questionnaire

Full Information

First Posted
September 29, 2017
Last Updated
February 12, 2018
Sponsor
Yonsei University
search

1. Study Identification

Unique Protocol Identification Number
NCT03313453
Brief Title
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

2. Study Status

Record Verification Date
February 2018
Overall Recruitment Status
Completed
Study Start Date
August 16, 2017 (Actual)
Primary Completion Date
December 22, 2017 (Actual)
Study Completion Date
December 22, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Yonsei University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Allergic Rhinitis

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Masking Description
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.
Allocation
Randomized
Enrollment
44 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Aircleaner group
Arm Type
Experimental
Arm Description
PuriCare (HEPA Air Cleaner) in active mode
Arm Title
Control comparator
Arm Type
Placebo Comparator
Arm Description
Mock device of PuriCare in active mode
Intervention Type
Device
Intervention Name(s)
PuriCare (HEPA Air Cleaner)
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
Mock device of PuriCare
Intervention Description
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 Outcome Measure Information:
Title
Daily symptom score of allergic rhinitis
Description
Daily symptom score of allergic rhinitis: Rhinorrhea Nasal itchiness Sneezing Obstruction
Time Frame
6 weeks
Title
Daily medication score of allergic rhinitis
Description
Daily medication score of allergic rhinitis - Intranasal steroid Anti-histamine Leukotriene modifier
Time Frame
6 weeks
Secondary Outcome Measure Information:
Title
Visual analog scale of allergic rhinitis
Description
0 to 10 score of VAS
Time Frame
6 weeks
Title
Quality of life score of allergic rhinitis
Description
questionnaire
Time Frame
6 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
Division of Allergy and Immunology Department of Internal Medicine, Yonsei University College of Medicine
City
Seoul
ZIP/Postal Code
03722
Country
Korea, Republic of

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
27723364
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.
Results Reference
result
PubMed Identifier
32734732
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.
Results Reference
derived

Learn more about this trial

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

We'll reach out to this number within 24 hrs