Validation of the Efficacy of Air Purifiers in Indoor Environment and Allergic Symptoms in Allergic Rhinitis Patients

NCT06890572 | Recruiting

• 1 other identifier: 4-2024-1043
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

Brief Summary

This study targets adult patients between the ages of 19 and 60 who were diagnosed with allergic rhinitis caused by indoor inhalation antigens. Patients with moderate to severe and persistent allergic rhinitis who continue to require medication such as antihistamines and nasal spray steroids for allergic rhinitis are the subjects of this study. Patients who participate in the study will install air purifiers for a certain period of time and observe the objective and subjective improvement of rhinitis symptoms. The study is conducted on two separate occasions for four weeks, and there is a two-week period between the two periods of no use of air purifiers. There are two types of air purifiers: 1)It is an air purifier with a HEPA filter and a VOC filter, and 2) a fake air purifier without air cleaning function. Subjects are divided into Group A and Group B. Group A will receive a fake air purifier, and Group B will be assigned an air purifier with a HEPA + VOC collecting filter. After using the assigned air purifier for the first four weeks, you will have a period of not using it for two weeks, and then replace the air purifiers with each other and use it again for four weeks. When you first assign an air purifier, you will receive an air purifier with a certain filter It is randomly assigned without knowing whether both the researcher and the patient will receive a regular period. During the study period, patients need to visit three times, including when registering for the study, and the study period is screened It will take about 5 months from the end of the air purifier operation

Conditions

Rhinitis Allergic

Outcome Measures

Primary Outcomes (1)

• Change of indoor total volatile organic compound concentration

  The indoor air collected through the air purifier is analyzed to evaluate the total indoor volatile organic compound concentration.

  up to 12 weeks

Secondary Outcomes (10)

• Change of indoor formaldehyde concentrations

  up to 12 weeks

• Change of indoor NO2 concentrations

  up to 12 weeks

• Change of indoor PM10 concentrations

  up to 12 weeks

• Change of indoor PM2.5 concentrations

  up to 12 weeks

• Change of indoor PM1.0 concentrations

  up to 12 weeks

Study Arms (2)

pre-placebo/post-Intervention group

OTHER

Group A will receive a fake air purifier during study period 1, and during study 2, the HEPA+VOC filter air purifier will be operated.

Device: HEPA + VOC collecting filter purifier; Device: fake air purifier

pre-Intervention/post-placebo group

OTHER

Group A will receive the HEPA+VOC filter air purifier during study period 1, and during study 2, a fake air purifier will be operated.

Device: HEPA + VOC collecting filter purifier; Device: fake air purifier

Interventions

HEPA + VOC collecting filter purifier DEVICE

Subjects operate HEPA + VOC collecting filter purifier

pre-Intervention/post-placebo group; pre-placebo/post-Intervention group

fake air purifier DEVICE

Subjects operate fake air purifiers

pre-Intervention/post-placebo group; pre-placebo/post-Intervention group

Eligibility Criteria

• Age: 19 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• adults aged 19 to 60
• A person with moderate-severe persistent allergic rhinitis diagnosed by an allergy specialist or otolaryngologist and maintained without any change in treatment for more than one month
• Total nasal symptom Score ≥ 8
• Patients with allergic rhinitis caused by indoor inhalation antigen antigens (House dust mites ± If the wheal size of the pet skin test is greater than 3mm or the concentration of specific IgE measured by ImmunoCAP ≥ 0.35 kUA/L)
• A person who spends at least 8 hours/day per week in the home where the cleaner will be installed
• A person with a wi-fi installed in the home where the purifier will be installed
• A person who can read and write in Korean
• A person who fully explains the contents, decides to participate in the study according to his/her free will, and signs a written consent form approved by each agency IRB

You may not qualify if:

• Patients sensitized to seasonal antigens (tree, grass or weed pollen)
• Rhinitis patients caused by causes other than allergic rhinitis (drug rhinitis, vascular rhinitis, infectious rhinitis, etc.)
• Anyone who has required more than 2 weeks of systemic steroid use in the last 3 months
• A person taking antihistamines for reasons other than rhinitis (chronic urticaria, etc.)
• Those with anatomical abnormalities that cause nasal congestion, such as non-segmental curvature and non-segmental species
• A person who has a plan to move during the study period or is scheduled to leave where air purifiers are installed for at least five consecutive days (e.g., travel, business trip, etc.)
• A person who has already used an air purifier within the last three months
• Pregnant women, lactating women, persons lacking decision-making ability, persons accommodated in facilities
• A person whose researcher is deemed unfit to participate in clinical research due to other reasons

Sponsors & Collaborators

• Yonsei University: lead
• LG Electronics Inc.: collaborator

Study Sites (1)

Yonsei University

Seoul, 03722, South Korea

RECRUITING

MeSH Terms

Conditions

Rhinitis, Allergic, Perennial

Condition Hierarchy (Ancestors)

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

Study Officials

• Kyung Hee Park

  Yonsei University Health System, Severance Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Kyung Hee Park

CONTACT

+82-2-2228-1947; white182@yuhs.ac

Im Shin

CONTACT

+82-2-2228-5884; si1011@yuhs.ac

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Associate Professor

Study Record Dates

• First Submitted: February 26, 2025
• First Posted: March 24, 2025
• Study Start: March 11, 2025
• Primary Completion: May 23, 2025
• Study Completion: June 20, 2025
• Last Updated: March 24, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)