Is a Single Daily Session Combining Hypertonic Saline Nebulisation and Airway Clearance Techniques Sufficient to Obtain Long-term Clinical Benefits in People With Bronchiectasis? A Randomised Non-inferiority Trial.
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Impact of coughing on quality of life
研究概览
简要总结
The present study will aim to find out whether a home treatment in people with bronchiectasis consisting of a single daily session to facilitate expectoration (combining nebulization of hypertonic saline (HS) at 6% followed by airway clearance techniques) is at least as effective as performing two sessions per day following the same process in each of the sessions, during a period of 6 months.
详细描述
A non-inferiority randomised clinical trial (single-blind) will be conducted. At least 50 participants will be recruited from the outpatient clinics of the Hospital Clinic in Barcelona and the Clinical University Hospital in Zaragoza. The experimental group will nebulize once/day the hypertonic saline (HS) solution followed by airway clearance exercises (15 min) for 6 months. The control group will follow the same procedure, but the frequency of the sessions will be twice a day (reference as usual clinical practice). The main study outcomes will be: (1) cough severity (primary endpoint), symptoms and quality of life; (2) functional exercise capacity; (3) time to first exacerbation and total number of exacerbations; (4) indirect measures of mucociliary transport (rheology and concentration of solids in sputum samples); (5) inflammatory parameters; (5) tolerance, safety and adherence to treatment. Measurements will be taken at baseline (prior to randomization), at 1 month, 3 months, and 6 months. Finally, hypothesis testing will be performed using a linear mixed model (2x3) of repeated measures, establishing a priori a margin of non-inferiority.
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
- Single (Outcomes Assessor)
盲法说明
The assessors in charge of the measures will be blind to the group assignment of participants until the study has been completed
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
- •18 years or older
- •a total score less than 16 on the Leicester Cough Questionnaire
- •chronic daily expectoration over at least 3 months
- •being in a period of clinical stability during the previous 4 weeks
- •presenting a forced expiratory volume in 1 second (FEV1) value greater than 40% of predicted or >1 L
- •obtaining informed consent.
- •In addition, all participants will have had to satisfactorily pass the tolerability tests, which will be performed twice: i) on the first day; ii) and the following week.
排除标准
- •having received nebulised mucoactive treatment during the previous year
- •frequent haemoptysis (≥ 2 times/month)
- •diagnosis or suspicion of cystic fibrosis by genetic study or sweat test
- •being under active treatment for nontuberculous mycobacteria (NTM)
结局指标
主要结局
Impact of coughing on quality of life
时间窗: 6 months after starting the intervention
The Leicester Cough Questionnaire (LCQ) will be used to assess the daily cough impact
次要结局
- Impact of coughing on quality of life(Baseline point, 1 month and 3 months after starting the intervention)
- Disease-specific quality of life questionnaire(Baseline point, 1 month, 3 months and 6 months after starting the intervention)
- Biophysical properties of spontaneous sputum samples(Baseline point, 1 month, 3 months, 6 months)
- Exercise capacity(Baseline point)
- Exacerbations(From baseline point to the end of the intervention (6 months))
- Disease-specific symptoms questionnaire(Baseline point, 1 month, 3 months and 6 months after starting the intervention)
- Inflammation markers (airway inflammation and systemic inflammation)(Baseline point, 1 month, 3 months, 6 months)
研究者
Beatriz Herrero-Cortina
PhD Beatriz Herrero Cortina
Hospital Clínico Universitario Lozano Blesa