Sputum Clearance Effects of Hypertonic Saline in Non-cystic Fibrosis Bronchiectasis: a Randomized, Double-blind, Crossover Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Wet sputum production
研究概览
简要总结
This study aims to analyze whether the hypertonic saline nebulization enhances sputum clearance effects, reduces the impact on cough severity and their level of safety and tolerability in a population with non-cystic fibrosis bronchiectasis (NCFBE). In addition, this trial aims to compare these health outcomes among 3 nebulized solutions: hypertonic saline (7%); hyaluronic acid + hypertonic saline (7%); isotonic saline (0,9%).
详细描述
The present study will be a randomized, double-blind, crossover trial. Each nebulized solution [hypertonic saline (7%); hyaluronic acid + hypertonic saline (7%); isotonic saline (0,9%)] will be administrated during 4 days. After each inhalation, all patients will carry out a bronchial drainage session (autogenic drainage technique). All patients recruited will perform the three arms of intervention. In this way, each patient will be able to act as his/her own control.
A 7 days washout period will be required among the different solutions to avoid carryover effects.
During the study period the patients' pharmacological treatment remained unchanged.
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
- Triple (Participant, Investigator, Outcomes Assessor)
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
- •Non-cystic Fibrosis bronchiectasis (NCFBE) diagnosed by High Resolution Computed Tomographic
- •Mean sputum production ≥ 10 ml /24h.
- •Clinical stability in the last 4 weeks
- •To be able to understand how to perform inhalation and the physiotherapy session.
- •To be able to provide written, informed consent
排除标准
- •Forced expiratory volume in 1 second < 30% pred. ; Total lung capacity < 45% pred.
- •Performing nebulization with any hyperosmolar agents, previously
- •Allergic bronchopulmonary aspergillosis diagnosis
- •Not to be able to overcome the safety test pre-intervention (oxygen saturation levels drop to < 90% and/or forced expiratory volume in 1 second decline more than < 12% from baseline during the nebulization process)
研究组 & 干预措施
Hypertonic saline solution
Hypertonic saline (7%) solution (5 ml) will be nebulized by all patients in a randomized order. Immediately after, patients will perform a bronchial drainage session. The airway clearance technique selected will be autogenic drainage (AD).
Both patients and physiotherapist will be blind to the intervention.
干预措施: Hypertonic saline solution (Other)
Hyaneb solution
Hyaneb (acid hyaluronic + hypertonic saline [7%]) solution (5 ml) will be nebulized by all patients in a randomized order. Immediately after, patients will perform a bronchial drainage session. The airway clearance technique selected will be autogenic drainage (AD).
Both patients and physiotherapist will be blind to the intervention.
干预措施: Hyaneb solution (Other)
Isotonic saline solution
Isotonic saline (0,9%) solution (5 ml) will be nebulized by all patients in a randomized order. Immediately after, patients will perform a bronchial drainage session. The airway clearance technique selected will be autogenic drainage (AD).
Both patients and physiotherapist will be blind to the intervention.
干预措施: Isotonic saline solution (Other)
结局指标
主要结局
Wet sputum production
时间窗: 1h wet sputum production (g)
Sputum collected during nebulization period and physiotherapy session
次要结局
- Lung function (Forced spirometry)(One week)
- Safety and tolerability (Adverse events)(20 minutes)
- Impact on cough severity (Leicester Cough Questionnaire)(One week)
- Wet sputum production(24h wet sputum production (g))
研究者
Eva Polverino
Post doctoral investigator
Hospital Clinic of Barcelona