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
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 44
- 试验地点
- 1
- 主要终点
- Change of indoor total volatile organic compound concentration
研究概览
简要总结
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
详细描述
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
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Supportive Care
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 19 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
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.
干预措施: HEPA + VOC collecting filter purifier (Device)
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.
干预措施: fake air purifier (Device)
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.
干预措施: HEPA + VOC collecting filter purifier (Device)
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.
干预措施: fake air purifier (Device)
结局指标
主要结局
Change of indoor total volatile organic compound concentration
时间窗: up to 12 weeks
The indoor air collected through the air purifier is analyzed to evaluate the total indoor volatile organic compound concentration.
次要结局
- Change of indoor PM2.5 concentrations(up to 12 weeks)
- 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 PM1.0 concentrations(up to 12 weeks)
- Change of Allergic rhinitis symptom score (Total natal symtom score)(up to 12 weeks)
- Changes in the use of anti-allergic rhinitis medication (Rescue Medication Score)(up to 12 weeks)
- A change in Quality of Life by Allergic Rhinitis(up to 12 weeks)
- Change of odor score(up to 12 weeks)
- Change in the time required for indoor pollutants to decrease from maximum concentration to baseline(up to 12 weeks)
研究者
Park Kyung Hee
Clinical Associate Professor
Yonsei University