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临床试验/NCT03627689
NCT03627689终止不适用

Molekule for Allergic Rhinitis/Asthma

Molekule2 个研究点 分布在 1 个国家目标入组 49 人开始时间: 2018年7月13日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
终止
发起方
入组人数
49
试验地点
2
主要终点
Control of Allergic Rhinitis and Asthma Test (CARAT) score

研究概览

简要总结

Exposure to airborne allergens and pollutants is linked to symptom severity of allergies, asthma and other respiratory problems. In this study an air purifier using photo-electrochemical oxidation technology (PECO) will be used in the home environment of study participants. The investigator will assess the reduction of symptoms from allergic rhinitis/conjunctivitis and asthma.

详细描述

The purpose of this study is to assess the efficacy of the portable PECO air purifier in reducing symptoms from allergic rhinitis and asthma. Using a randomized, double blinded placebo, controlled trial we will be then able to assess if there are any changes after the use of the PECO air purifier after completing an initial baseline survey & comparing to the exit survey. This is a double-blind study, which means that neither the participant nor the investigator knows which device is being used until after the trial is over.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Double (Participant, Investigator)

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Chronic allergic rhinitis and/or conjunctivitis by history
  • History of adult asthma requiring medications now or in the past
  • CARAT score less than 24

排除标准

  • Participant is <18 years-old
  • Use of systemic corticosteroids within 14 days of study initiation
  • Treatment with biologic agents or allergen immunotherapy
  • Treatment with other immunomodulators (cyclosporine, azathioprine, hydroxychloroquine, etc)
  • Sensitive to fan sound or blue/purple light at night time

研究组 & 干预措施

Active air purifier arm

Experimental

Active portable air purifier for 1 month at bedside

干预措施: Active air purifier in respiratory allergies/asthma (Other)

Sham air purifier arm

Sham Comparator

Placebo portable air purifier for 1 month at bedside

干预措施: Sham air purifier (Other)

结局指标

主要结局

Control of Allergic Rhinitis and Asthma Test (CARAT) score

时间窗: 4 weeks

CARAT will measure the change in control scores of respiratory allergies and asthma. Scale 0 (Worse control of allergy and asthma) to 30 (Best control of allergy and asthma). The higher score the better control of allergy and asthma. There are 10 individual questions, scoring from 0-3.

次要结局

未报告次要终点

研究者

发起方
Molekule
申办方类型
Industry
责任方
Sponsor

研究点 (2)

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