Clinical Effects of Purified Air Administered to the Breathing Zone in Allergic Asthma
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Airsonett AB
- 入组人数
- 28
- 试验地点
- 4
- 主要终点
- Quality of life assessed by mini Asthma Quality of Life Questionnaire (miniAQLQ)
研究概览
简要总结
The purpose of this study is to determine whether clean air administered to the breathing zone with Temperature controlled Laminar Airflow (TLA) during night is effective in the treatment of perennial allergic asthma.
详细描述
Background: Exposure to inhaled allergens is a pathogenetic factor in allergic asthma. However, most studies that previously looked at air cleaning devices have shown little or no effect on patients with perennial allergic asthma. Aims and objectives: This study aims to investigate a novel treatment, TLA, using temperature controlled laminar airflow with a very low particle concentration directed to the breathing zone of teenagers and adults with allergic asthma during night sleep. The hypothesis is that the decreased allergen exposure during the night will have an effect on bronchial inflammation and quality of life. Method: Patients are randomized to start with active or placebo treatment for 10 weeks. All patients receive both active and placebo treatment with unfiltered air, with a 2-week wash-out period in between treatments. Maintenance treatment with inhaled corticosteroids is unaltered during the trial period. Health related quality of life (miniAQLQ)is the primary effectiveness measure. Exhaled nitric oxide (FeNO) and spirometry are also investigated.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 12 Years 至 28 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosed for asthma for more than 1 year.
- •More than 12% reactivity in FEV1 on bronchodilating medication or less than 90% of the FEV1 reference value according to Hedenström.
- •Perennial allergy
- •At least 3-mm wheal reaction in a skin prick test to at least one of following: House dust, Mold spores, dust mites, animal hair and dander.
- •Little or no reactivity to other inhalant allergens.
- •No known allergy to another inhalant allergen or chemical to which there is exposure in winter time.
- •No allergen injection treatment in the preceding 2 years.
- •A history of a requirement for daily medication for asthma including;
- •400µg steroid medication (Pulmicort or equal) for children and 800µg for adults.
- •Beta agonist treatment on less than 4 days per week.
- •Willingness to follow the clinical trial protocol, including medications, baseline and follow-up visits and procedures.
排除标准
- •Inclusion in another Allergen avoidance program.
- •Smoking in the family
- •Participation in a drug trial
结局指标
主要结局
Quality of life assessed by mini Asthma Quality of Life Questionnaire (miniAQLQ)
时间窗: Every 2 weeks of the study period
次要结局
- Lung function (FeV1, PEF)(Every 5 week of the study period)
- Airway inflammation measurement assessed by Exhaled nitric oxide (FeNO)(Every 5 week of the study period)