Safety and Effectiveness of the Alair® System for the Treatment of Asthma: A Multicenter Randomized Clinical Trial(Asthma Intervention Research (AIR2) Trial)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 297
- 试验地点
- 39
- 主要终点
- Integrated Asthma Quality of Life Questionnaire (AQLQ) Score (Change From Baseline)
研究概览
简要总结
The objective of this randomized, double blind, sham-controlled study is to demonstrate the safety and effectiveness of the Alair System in a population of subjects with severe asthma who are still symptomatic despite being managed on conventional therapy of high doses of inhaled corticosteroids and long-acting β2-agonists.
The primary efficacy endpoint will be the difference between Study groups in the change in Asthma Quality of Life Questionnaire (AQLQ) score from Baseline and the average score from the 6-, 9-, and 12-month follow-up visits.
All other outcome measures assessed at 12 months post-treatment.
This will be a multicenter, randomized, double-blind, sham-controlled study comparing the effects of treatment with the Alair System to conventional therapy of inhaled corticosteroids (ICS) and long-acting β2-agonists (LABA).
A Bayesian adaptive approach to sample size selection is used with a randomization scheme of 2:1 (two Alair Group Subjects for every one Control Group Subject).
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
- Double (Participant, Outcomes Assessor)
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
- 否
入选标准
- •Subject is an adult between the ages of 18 to 65 years.
- •Subject has asthma and is taking regular maintenance medication that includes Inhaled corticosteroid (ICS) AND long acting ß2-agonist (LABA).
- •Subject has a Pre-bronchodilator Forced Expiratory Volume in one second (FEV1) of greater than or equal to 60% of predicted after medication stabilization during the Baseline Period.
- •Subject has a PC20 < 8 mg/ml per methacholine inhalation test using standardized methods. PC20 is a provocative concentration of Provocholine® (a brand of methacholine chloride) resulting in a drop of FEV1 of 20% or more from Baseline.
- •Subject has at least two days of asthma symptoms during the 4-weeks of the Baseline Diary Period.
- •Subject is a non-smoker for 1 year or greater (if former smoker, less than 10 pack years total smoking history).
排除标准
- •Subject has a Post-bronchodilator FEV1 of less than 65%.
- •Subject has 3 or more hospitalizations for exacerbations of asthma in the previous year; OR a history of life-threatening asthma, defined by past intubations for asthma, or ICU admission for asthma within the prior 24 months.
- •Subject has a history of recurrent lower respiratory tract infections requiring antibiotics (more than 3 in the past 12 months).
- •Subject has a history of recurrent oral steroid use for asthma (4 or more pulses of oral steroids in the past 12 months).
- •Subject has a known sensitivity to medications required to perform bronchoscopy (such as lidocaine, atropine and benzodiazepines).
- •Subject has known systemic hypersensitivity or contraindication to Methacholine chloride or other parasympathomimetic agents.
- •Subject has other medical criteria.
研究组 & 干预措施
Alair
Treatment of airways with the Alair System
干预措施: Alair System (Device)
Sham
Sham treatment of airways
干预措施: Alair System (Device)
结局指标
主要结局
Integrated Asthma Quality of Life Questionnaire (AQLQ) Score (Change From Baseline)
时间窗: Baseline, 12 Months
Change between Baseline and the average of 6-, 9-, and 12-month Follow-Up Visits. The AQLQ consists of 32 questions (scale from 1 to 7, where 7 reflects a higher quality of life). An increase in the AQLQ score indicates a better quality of life. The average of the 6-, 9-, and 12-month differences in the AQLQ Score are referred to as the "Integrated AQLQ Score."
次要结局
- Percent Symptom-Free Days (Change From Baseline)(Baseline, 12 Months)
- Total Symptom Score (Change From Baseline)(Baseline, 12 Months)
- Number of Puffs of Rescue Medication Used (Change From Baseline)(Baseline, 12 Months)
- Percent Days Rescue Medication Used (Change From Baseline)(Baseline, 12 Months)
- Asthma Control Questionnaire (ACQ) Score (Change From Baseline)(Baseline, 12 Months)
- Morning Peak Expiratory Flow (amPEF) (Change From Baseline)(Baseline, 12 Months)
- Pre-Bronchodilator FEV1 (Percent Predicted) (Change From Baseline)(Baseline, 12 Months)
- Post-Bronchodilator FEV1 (Percent Predicted) (Change From Baseline)(Baseline, 12 Months)