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

NCT ID: NCT06890572

Last Updated: 2025-03-24

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 44 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-03-11
• Study Completion Date: 2025-06-20

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

Detailed Description

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

A detailed chronological overview of the study is as follows

1. Screening and Baseline Visits (Visit 1) Before the process of the study begins, the study subjects are fully explained about the entire research process and checked whether they meet the selection and exclusion criteria. If the selection criteria are met, a written consent form will be written, basic demographic information (gender, age, medical history (including allergic disease-related and surgical history), and drug administration history (four weeks before registration). We will conduct a survey on subjective symptoms of allergic rhinitis, drug use scores, subjective score indicators, and quality of life evaluation indicators, and double-check the drugs currently being taken by the study subjects.

If you have previously used drugs for allergic rhinitis, you can maintain the medication without change and prescribe additional relief drugs if necessary.

2. Installation of air purifier and Study I after randomization Randomization is a method that is divided into groups A and B and is assigned based on a randomized list (random table) with statistician advice at a ratio of 1:1 respectively.

The first study (Study I) will run for four weeks. During this period, the air purifier will continue to operate, and no indoor ventilation will be performed for these four weeks to reduce other factors that may affect indoor air quality. After four weeks, the air purifier will be remotely controlled, and indoor air quality information will be continuously collected in the filter replacement.

3. Interim Visit (Visit 2) The subject of the study will visit the hospital with a journal written about the changes in symptoms and the use of drugs after the first operation of the purifier (Study I). During the first and second visits, the symptoms will be checked for differences and whether relief drugs have been used, and additional relief drugs will be prescribed if necessary, along with retraining on the next visit schedule.

4. Study II progress and end visit after replacement of air purifier filter (Visit 3) To proceed with the second study (Study II), LG Electronics installers revisit each home and install Dual Defense Filter (HEPA + VOC capture filter) in Group A. Conversely, Group B will remove the Dual Defense filter and attach void labels again each. Study II will also run for four weeks, during which the air purifier is continuously running and there is no indoor ventilation.

The subject of the study should visit the hospital with symptoms and drug use log even at the end of the visit, and the change in symptoms and the use of relief drugs will be confirmed. At the end of the study, we will disclose which group the study subjects were assigned to.

Conditions

Rhinitis Allergic

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: DOUBLE

Study Groups

pre-placebo/post-Intervention group

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.

Group Type: OTHER

HEPA + VOC collecting filter purifier

Intervention Type: DEVICE

Subjects operate HEPA + VOC collecting filter purifier

fake air purifier

Intervention Type: DEVICE

Subjects operate fake air purifiers

pre-Intervention/post-placebo group

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.

Group Type: OTHER

HEPA + VOC collecting filter purifier

Intervention Type: DEVICE

Subjects operate HEPA + VOC collecting filter purifier

fake air purifier

Intervention Type: DEVICE

Subjects operate fake air purifiers

Interventions

HEPA + VOC collecting filter purifier

Subjects operate HEPA + VOC collecting filter purifier

Intervention Type: DEVICE

fake air purifier

Subjects operate fake air purifiers

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• 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

• Minimum Eligible Age: 19 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

LG Electronics Inc.

INDUSTRY

Sponsor Role: collaborator

Yonsei University

OTHER

Sponsor Role: lead

Responsible Party

Park Kyung Hee

Clinical Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Kyung Hee Park

Role: PRINCIPAL_INVESTIGATOR

Yonsei University Health System, Severance Hospital

Locations

Yonsei University

Seoul, , South Korea

Site Status: RECRUITING

Countries

South Korea

Central Contacts

Kyung Hee Park

Role: CONTACT

white182@yuhs.ac

+82-2-2228-1947

Im Shin

Role: CONTACT

si1011@yuhs.ac

+82-2-2228-5884

Facility Contacts

Kyung Hee Park

Role: primary

white182@yuhs.ac

0222281947

Other Identifiers

4-2024-1043

Identifier Type: -

Identifier Source: org_study_id