Multicenter, Pragmatic, Randomized, Controlled Trial to Assess the Efficacy and Safety of Nocturnal Humidification Therapy in Patients With Bronchiectasis: the AIRVO-BX Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 130
- 试验地点
- 26
- 主要终点
- Pulmonary exacerbations
研究概览
简要总结
The aim of the study is to investigate whether long-term heated humidification therapy (AIRVO) administrated for 1 year over-night on top of standard therapy can reduce the number of exacerbations in adults with non-cystic fibrosis bronchiectasis.
详细描述
Bronchiectasis is a chronic condition characterized by an abnormal widened airways, mucus retention, cough, daily sputum, and frequent respiratory infections. The management of bronchiectasis includes prevention of exacerbations and lung infections along with airway clearance techniques.
Mucus composition and hydration are crucial to allow mucus transport along airways during respiratory physiotherapy.
Previous studies showed that long term humidification therapy increased airway clearance (Hasani et al. 2008) and reduced the number of exacerbations in patients with both bronchiectasis and Chronic Obstructive Pulmonary Disease (COPD) (Rea et al. 2010). myAIRVO2 system can deliver high-flow warm and humidified gases through a nasal cannula.
The aim of the present study to assess the effect of long-term use over-night of myAIRVO2 warm humidification in adults with bronchiectasis who experience at least 3 exacerbations/year still with optimized clinical and respiratory therapies.
In addition to their usual therapy, the treatment group will receive a myAIRVO2 humidifier at home deliver every day for one year over-night.
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
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Radiological evidence of bronchiectasis evaluated through a CT-scan of the chest
- •Daily sputum production
- •Presence of at least 3 exacerbations requiring antibiotic therapy during the 12 months prior randomization
- •Absence of exacerbations during the 28 days prior randomization
- •Having the bronchiectasis management/therapy optimized according to international guidelines (ERS Polverino 2017) during the 12 months preceding randomization and no changes in therapy occurred during the 28 days prior randomization
- •Airways clearance physiotherapy optimized and unchanged during the 12 months prior randomization
- •Being able to use myAIRVO2 (assessed by study investigators)
- •Given consent to inclusion in the study
排除标准
- •Being enrolled in other intervention trials during the 12 months prior randomization
- •COPD or asthma recognized as main diseases by the study investigator
- •Active smoker or ex-smoker who underwent smoking cessation during the 4 weeks prior randomization
- •Any other disease or medical condition diagnosed during the 3 months prior randomization which can affect patients' safety
- •Long-term treatment with non-invasive ventilation (NIV)
- •Long-term night treatment with continuous positive airway pressure (CPAP)
- •Tracheostomy
- •Major haemoptysis (more than 300ml or requiring embolization or requiring blood transfusion) during the 6 weeks prior randomization
- •Cystic fibrosis
- •Traction bronchiectasis in the context of pulmonary fibrosis
- •Lung cancer in the last 5 years
- •Use of drugs that can modify mucus liquid content including mannitol, Hypertoinc saline, DNase, NAC
- •Changes in the rehabilitation/respiratory therapy program during the 28 days before randomization
- •Pregnant and brest-feeding women
结局指标
主要结局
Pulmonary exacerbations
时间窗: baseline - 12 months
Number of pulmonary exacerbations
次要结局
- Days with symptoms of exacerbation(baseline - 12 months)
- Non-use of AIRVO therapy(baseline - 12 months)
- Time to first pulmonary exacerbation(Up to 12 months. From date of randomization until the date of first documented pulmonary exacerbation)
- Pulmonary function as change in Forced Expiratory Volume in 1 Second (FEV1)(baseline - 6 and 12 months)
- Bronchiectasis Health Questionnaire, that measures health-related quality of life(baseline - 6 and 12 months)
- Pulmonary exacerbations requiring hospitalization(baseline - 12 months)
- St.George Respiratory Questionnaire, that measures health-related quality of life(baseline - 6 and 12 months)
- Adverse events(baseline - 12 months)
- Leicester Cough Questionnaire, that measures health-related quality of life(baseline - 6 and 12 months)
- Time to first hospitalization for exacerbation(Up to 12 months.From date of randomization until the date of first documented hospitalization for pulmonary exacerbation)
- Days of anibiotic treatment for exacerbation(baseline - 12 months)
- Patients requiring de novo oxygen therapy(baseline - 12 months)
- Quality-of-Life-Bronchiectasis Questionnaire, that measures health-related quality of life(baseline - 6 and 12 months)
- Pulmonary function as change in Forced Vital Capacity (FVC)(baseline - 6 and 12 months)
- Mortality(baseline - 12 months)
- Mortality due to respiratory causes(baseline - 12 months)