Rhinitis AllergicNCT06890572
Validation of the Efficacy of Air Purifiers in Indoor Environment and Allergic Symptoms in Allergic Rhinitis Patients
A study testing HEPA + VOC collecting filter purifier and fake air purifier in people with Rhinitis Allergic, run by Yonsei University at 1 site in South Korea.
Trial 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… Read more about this study
- Who is it for?
- Ages 19 to 60 years
- Conditions the study is for
- Rhinitis Allergic
- What is being tested?
- HEPA + VOC collecting filter purifier and fake air purifier
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 1 siteSouth Korea
- Study dates
- 11 Mar 2025to 20 Jun 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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.)
Show all 9Show fewer
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
South Korea1 site, 1 recruiting
- Recruiting
Yonsei University
Seoul, 03722
Kyung Hee Park, 0222281947, white182@yuhs.ac
About this study
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
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:
Read more
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
Read the 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
- 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.
- 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.
- 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.
- 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
- Being tested
- HEPA + VOC collecting filter purifier, fake air purifier
- Medical subject headings
- Rhinitis, Allergic, Perennial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HEPA + VOC collecting filter purifierDevice
Subjects operate HEPA + VOC collecting filter purifier
fake air purifierDevice
Subjects operate fake air purifiers
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Device: HEPA + VOC collecting filter purifier; Device: fake air purifier |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: up to 12 weeks
Secondary outcomes (10)
Change of indoor formaldehyde concentrations
Measure the indoor formaldehyde concentration through the air purifier
Measured: up to 12 weeks
Change of indoor NO2 concentrations
Measure the indoor NO2 concentration through the air purifier
Measured: up to 12 weeks
Change of indoor PM10 concentrations
Measure the indoor PM10 concentration through the air purifier
Measured: up to 12 weeks
Change of indoor PM2.5 concentrations
Measure the indoor PM2.5 concentration through the air purifier
Measured: up to 12 weeks
Change of indoor PM1.0 concentrations
Measure the indoor PM1.0 concentration through the air purifier
Measured: up to 12 weeks
Change of Allergic rhinitis symptom score (Total natal symtom score)
TNSS has a total score of 12, and evaluate the degree of runny nose, sneezing, stuffy nose, and itchy nose. A score of 0 is no symptom, a score of 1 is mild (symptomatic/symptomatic but mild and easily tolerable), a score of 2 is moderate (symptomatic/symptomatic but tolerable), and a score of 3 is severe (symptomatic/symptomatic and difficult to bear and interfere with daily life or sleep). the higher the score, the more severe the rhinitis symptoms
Measured: up to 12 weeks
Changes in the use of anti-allergic rhinitis medication (Rescue Medication Score)
Rescue Medication Score is evaluated from 0 to 2. A score of 0 means no additional medication, a score of 1 means additional use of oral or nasal antihistamines, and a score of 2 means additional use of nasal steroids, and a higher score means more rhinitis symptoms
Measured: up to 12 weeks
A change in Quality of Life by Allergic Rhinitis
Evaluate using the quality of life questionnaire. The quality of life evaluation questionnaire is a questionnaire investigating the impact of allergic rhinitis on patients' lives for a week. The higher the score, with a total score of 60, the more severe the symptoms of rhinitis.
Measured: up to 12 weeks
Change of odor score
valuate the subjective level of smell that a subject feels in the home. A score of 0 is odorless (relatively odorless and usually unable to detect anything with his or her sense of smell), a score of 1 is a sensed smell (the smell is unknown but capable of feeling the smell), a score of 2 is a normal smell (the smell is strong enough to know what it is), a score of 3 is a strong smell (the smell is strong enough to detect easily), a score of 4 is an extreme smell (a strong smell, for example, from a conventional toilet in summer), and a score of 5 is an unbearable smell (the strong smell that is difficult to endure and feels like stopping breathing). A total of five points means that the higher the score, the more severe the smell is.
Measured: up to 12 weeks
Change in the time required for indoor pollutants to decrease from maximum concentration to baseline
Through the data collected by the air purifier, the time required for the indoor pollutant source to be reduced from the maximum concentration to the baseline is measured.
Measured: up to 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2025
- Study start11 Mar 2025
- Primary completion23 May 2025 (estimated)
- Study completion20 Jun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rhinitis AllergicStudies of the same condition, open and under way.
- More trials run by Yonsei UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 44 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yonsei University
- Sponsor type
- University, hospital or other
- Collaborators
- LG Electronics Inc.
- Responsible party
- Principal investigator, Park Kyung Hee, Yonsei University
- Investigators
- Kyung Hee Park, Principal investigator, Yonsei University Health System, Severance Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06890572
- Sponsor's protocol ID
- 4-2024-1043
- Status last verified
- Mar 2025
- First submitted
- 26 Feb 2025
- Last updated
- 24 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06890572
- Acronym / sponsor ID
- 4-2024-1043
- Conditions
- Rhinitis Allergic
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 44 participants (estimated)
- Lead sponsor
- Yonsei UniversityUniversity, hospital or other
- Collaborators
- LG Electronics Inc.
- Study start
- 11 Mar 2025 (actual)
- Primary completion
- 23 May 2025 (estimated)
- Study completion
- 20 Jun 2025 (estimated)
- First posted
- 24 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- 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.
- 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.
- 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.
- 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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| pre-placebo/post-Intervention group | Other | Device: HEPA + VOC collecting filter purifier, Device: fake air purifierGroup A will receive a fake air purifier during study period 1, and during study 2, the HEPA+VOC filter air purifier will be operated. |
| pre-Intervention/post-placebo group | Other | Device: HEPA + VOC collecting filter purifier, Device: fake air purifierGroup A will receive the HEPA+VOC filter air purifier during study period 1, and during study 2, a fake air purifier will be operated. |
Who may qualify
- Ages
- 19 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HEPA + VOC collecting filter purifierSubjects operate HEPA + VOC collecting filter purifier | Device | pre-Intervention/post-placebo group, pre-placebo/post-Intervention group |
| fake air purifierSubjects operate fake air purifiers | Device | pre-Intervention/post-placebo group, pre-placebo/post-Intervention group |
Primary outcome
Change of indoor total volatile organic compound concentration
Time frame: up to 12 weeks
The indoor air collected through the air purifier is analyzed to evaluate the total indoor volatile organic compound concentration.
10 secondary outcomes
Change of indoor formaldehyde concentrations
Time frame: up to 12 weeks
Change of indoor NO2 concentrations
Time frame: up to 12 weeks
Change of indoor PM10 concentrations
Time frame: up to 12 weeks
Change of indoor PM2.5 concentrations
Time frame: up to 12 weeks
Change of indoor PM1.0 concentrations
Time frame: up to 12 weeks
Change of Allergic rhinitis symptom score (Total natal symtom score)
Time frame: up to 12 weeks
Changes in the use of anti-allergic rhinitis medication (Rescue Medication Score)
Time frame: up to 12 weeks
A change in Quality of Life by Allergic Rhinitis
Time frame: up to 12 weeks
Change of odor score
Time frame: up to 12 weeks
Change in the time required for indoor pollutants to decrease from maximum concentration to baseline
Time frame: up to 12 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Mar 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Kyung Hee Park principal investigator
Yonsei University Health System, Severance Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing HEPA + VOC collecting filter purifier and fake air purifier in people with Rhinitis Allergic, run by Yonsei University at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 24 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Kyung Hee Park (+82-2-2228-1947, white182@yuhs.ac), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of indoor total volatile organic compound concentration (time frame: up to 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Mar 2025.