Clinical trial NCT06890572: Validation of the Efficacy of Air Purifiers in Indoor Environment and Allergic Symptoms in Allergic Rhinitis Patients
Official title: Clinical Validation of the Efficacy of Air Purifiers Equipped With Harmful Gas Filters in Improving Indoor Environment and Alleviating Allergic Symptoms in Allergic Rhinitis Patients
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Rhinitis Allergic
Lead sponsor: Yonsei University
Sponsor class: OTHER
Collaborators: name: LG Electronics Inc.
First posted: 2025-03-24
Enrollment: 44
Sex: ALL
Minimum age (years): 19
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: SUPPORTIVE_CARE

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.

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

Primary outcomes:
measure: Change of indoor total volatile organic compound concentration
timeFrame: up to 12 weeks
Secondary outcomes:
measure: Change of indoor formaldehyde concentrations
timeFrame: up to 12 weeks
measure: Change of indoor NO2 concentrations
timeFrame: up to 12 weeks
measure: Change of indoor PM10 concentrations
timeFrame: up to 12 weeks
measure: Change of indoor PM2.5 concentrations
timeFrame: up to 12 weeks
measure: Change of indoor PM1.0 concentrations
timeFrame: up to 12 weeks
measure: Change of Allergic rhinitis symptom score (Total natal symtom score)
timeFrame: up to 12 weeks
measure: Changes in the use of anti-allergic rhinitis medication (Rescue Medication Score)
timeFrame: up to 12 weeks
measure: A change in Quality of Life by Allergic Rhinitis
timeFrame: up to 12 weeks
measure: Change of odor score
timeFrame: up to 12 weeks
measure: Change in the time required for indoor pollutants to decrease from maximum concentration to baseline
timeFrame: up to 12 weeks
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Yonsei University
Study officials:
affiliation: Yonsei University Health System, Severance Hospital
name: Kyung Hee Park
role: PRINCIPAL_INVESTIGATOR
References: