Allergic RhinitisNCT03313453
Effect of Air Cleaner on the Indoor Allergen Sensitized Allergic Rhinitis Patients
A study testing PuriCare (HEPA Air Cleaner) and Mock device of PuriCare in people with Allergic Rhinitis, run by Yonsei University at 1 site in South Korea.
Trial 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. Read more about this study
- Who is it for?
- Ages 19 to 65 years
- Conditions the study is for
- Allergic Rhinitis
- What is being tested?
- PuriCare (HEPA Air Cleaner) and Mock device of PuriCare
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 44 participants
- Where
- 1 siteSouth Korea
- Study dates
- 16 Aug 2017to 22 Dec 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
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- 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
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Division of Allergy and Immunology Department of Internal Medicine, Yonsei University College of Medicine
Seoul, 03722
About this study
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
Read the 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.
- Conditions
- Allergic Rhinitis
- Being tested
- PuriCare (HEPA Air Cleaner), Mock device of PuriCare
- Medical subject headings
- Rhinitis, Allergic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PuriCare (HEPA Air Cleaner)Device
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.
Mock device of PuriCareDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Aircleaner group | Experimental | PuriCare (HEPA Air Cleaner) in active mode Receives: Device: PuriCare (HEPA Air Cleaner) |
| Control comparator | Placebo comparator | Mock device of PuriCare in active mode Receives: Device: Mock device of PuriCare |
What is being measured
The primary outcome is the main question the study is designed to answer.
Daily symptom score of allergic rhinitis
Daily symptom score of allergic rhinitis:
- Rhinorrhea
- Nasal itchiness
- Sneezing
- Obstruction
Measured: 6 weeks
Daily medication score of allergic rhinitis
Daily medication score of allergic rhinitis - Intranasal steroid
- Anti-histamine
- Leukotriene modifier
Measured: 6 weeks
Secondary outcomes (2)
Visual analog scale of allergic rhinitis
0 to 10 score of VAS
Measured: 6 weeks
Quality of life score of allergic rhinitis
questionnaire
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Oct 2017
- Study start16 Aug 2017
- Primary completion22 Dec 2017
- Study completion22 Dec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Allergic RhinitisStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yonsei University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03313453
- Sponsor's protocol ID
- 4-2017-0588
- Status last verified
- Feb 2018
- First submitted
- 29 Sep 2017
- Last updated
- 13 Feb 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 27723364Park 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.
PubMed 32734732
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Air Cleaner on the Indoor Allergen Sensitized Allergic Rhinitis Patients
- ClinicalTrials.gov ID
- NCT03313453
- Acronym / sponsor ID
- 4-2017-0588
- Conditions
- Allergic Rhinitis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- Yonsei UniversityUniversity, hospital or other
- Study start
- 16 Aug 2017 (actual)
- Primary completion
- 22 Dec 2017 (actual)
- Study completion
- 22 Dec 2017 (actual)
- First posted
- 18 Oct 2017 (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 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Aircleaner group | Experimental | Device: PuriCare (HEPA Air Cleaner)PuriCare (HEPA Air Cleaner) in active mode |
| Control comparator | Placebo comparator | Device: Mock device of PuriCareMock device of PuriCare in active mode |
Who may qualify
- Ages
- 19 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (10 listed)
- 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.
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 |
|---|---|---|
| PuriCare (HEPA Air Cleaner)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. | Device | Aircleaner group |
| Mock device of PuriCareThe 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. | Device | Control comparator |
Primary outcome
Daily symptom score of allergic rhinitis
Time frame: 6 weeks
Daily symptom score of allergic rhinitis: * Rhinorrhea * Nasal itchiness * Sneezing * Obstruction
Daily medication score of allergic rhinitis
Time frame: 6 weeks
Daily medication score of allergic rhinitis - Intranasal steroid * Anti-histamine * Leukotriene modifier
2 secondary outcomes
Visual analog scale of allergic rhinitis
Time frame: 6 weeks
Quality of life score of allergic rhinitis
Time frame: 6 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Feb 2018.
- Results publication: PubMed 27723364Park 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.
- Derived from this study: PubMed 32734732Park 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.
- 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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PuriCare (HEPA Air Cleaner) and Mock device of PuriCare in people with Allergic Rhinitis, 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 6 inclusion and 10 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: finished, as of the sponsor's last update on 13 Feb 2018. 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. Some participants in this study may receive a placebo. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Daily symptom score of allergic rhinitis (time frame: 6 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03313453, which also lists 2 linked publications.
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 13 Feb 2018.