Airsonett Airshower in Allergic Asthma a Double-blind Randomized Multi-centre Trial
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Airsonett AB
- 入组人数
- 312
- 试验地点
- 20
- 主要终点
- miniAQLQ (Mini Asthma Quality of Life Questionnaire, Appendix 1) and the corresponding paediatric PAQLQ score.
研究概览
简要总结
The purpose of this study is to determine whether nocturnal environmental control with Temperature controlled Laminar Airflow (TLA) is effective as add on treatment in patients with perennial allergic asthma.
详细描述
Exposure to inhaled allergens is a pathogenetic factor in allergic asthma. However, physical, chemical and combined methods aiming to reduce airborne allergen levels have shown little or no effect in reducing asthma symptoms in people who are sensitive to perennial allergens.Aims and objectives: This study aims to investigate treatment with Temperature controled Laminar Airflow (TLA) with a very low particle concentration directed to the breathing zone in subjects with allergic asthma during night sleep. The hypothesis is that the decreased allergen exposure during the night will have an effect on quality of life and bronchial inflammation.
Method: This is a multicentre, double blind, randomized 52 week parallel trial comparing active TLA treatment with Placebo. For ethical reasons the randomization is 2 to 1 for active and placebo treatment, respectively. A 2 weeks run-in period is inserted between inclusion and randomization, during which the patient shall get familiar with the use of the patient asthma diary and to adhere to the requirements of the study participation. First 12 weeks an unchanged maintenance medication will be kept and week 13-52 medication will be modified to obtain asthma control according to international guidelines (GINA). After inclusion, run-in, randomization and baseline measurements active/placebo treatment with AA will be implemented over 52 weeks.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 7 Years 至 70 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Consent to participate voluntarily. Willing and able to comply with the study specific procedures. Signed Informed Consent prior to any study procedure.
- •Perennial allergic asthma, male and female, age 7 through 70 years, at time of randomization.
- •A miniAQLQ/PAQLQ score of ≤ 5.
- •Sensitive to pet allergen and/or house dust mites as demonstrated by changed to RAST 0.70 or positive skin prick test (wheal reaction similar to histamine control).
- •Daily maintenance dose of at least ICS ≥200µg/day of budesonide or ≥100µg/day of fluticasone since at least 6 months
- •Features of partly controlled asthma according to GINA
排除标准
- •Current smoker (Non-smoker is defined as abstinent since > 1 year). Children: Parents'indoor smoking.
- •Participation in another allergen avoidance program
- •Participation in drug trial the preceding 3 months
- •Multiple chemical sensitivity (e.g. paint, petrol, perfumes) as primary etiology
- •Allergen injection or sublingual treatment in the preceding 2 years
- •ICS ≥1200µg/day of budesonide or 1000µg/day of fluticasone
- •Significant cardiovascular disease
- •Participation in the present trial of a family member within the same household
- •Other protocol-defined exclusion criteria may apply
结局指标
主要结局
miniAQLQ (Mini Asthma Quality of Life Questionnaire, Appendix 1) and the corresponding paediatric PAQLQ score.
时间窗: Week -2, 0, 4, 12, 24, 36 and 52
次要结局
- FENO (Nitric Oxide in Exhaled Air)(Week -2, 0, 4, 12, 24, 36 and 52)
- Lung function assessed by forced expiratory volume (FEV1), PEF (Expiratory peak flow) and FEF50 (Predicted Forced Expiratory Flow Rate at 50 Percent of Vital Capacity)(Week -2, 0, 4, 12, 24, 36 and 52)
- Rhinitis symptoms assessed by questionnaire(Week 0 and 52)
- RAST value and eosinophil count.(Week 0 and 52)
- Asthma Control Test (ACT).(Week -2, 0, 12, 24, 36 and 52)
- Resource consumption(Week 0, 4, 12, 24, 36 and 52)