Characterization of Mucus Solids Concentration in Patients With Bronchiectasis: Cross-sectional Study
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 36
- 试验地点
- 1
- 主要终点
- Inter-sample variability of sputum concentration (% solids)
研究概览
简要总结
There is a need for biomarkers that can rapidly and sensitively detect therapeutic benefits of therapies designed to "rehydrate" airways and monitor disease severity and progression. In this study the investigators will evaluate the stability of mucus concentration in patients with bronquiectasis (CF and NCBF) and its ability to respond to acute exacerbations in order to assess whether it can be a good candidate for biomarker.
详细描述
Prospective cross-sectional study of repeated measurements. The recruitment will be performed in 3 different cities of Spain: Zaragoza, Barcelona and Murcia.
Subjects will be asked to repeatedly collect spontaneous and induced sputum samples in both stable and exacerbated conditions. All samples will be collected autonomously by patients in their homes after they have been instructed and supervised. Hypertonic saline nebulization will be used for sputum induction.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
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
- •Confirmed diagnosis of CF (confirmed genetics) or diagnosis of non-CF bronchiectasis through high resolution computed tomography.
- •Aged ≥ 18 years.
- •Clinically stable at the time of recruitment.
- •Chronic sputum production (able to produce spontaneous sputum daily).
- •Current hypertonic saline user.
- •Able to provide written informed consent and perform the trial.
排除标准
- •Current smoker or >10 pack-year history of tobacco use.
- •Patient in transplantation or retransplantation list.
结局指标
主要结局
Inter-sample variability of sputum concentration (% solids)
时间窗: 2 stable weeks
% solids will be calculated by measuring the wet to dry sputum weight ratio
次要结局
- Inter-sample variability of sputum concentration (% solids)(1 stable day (at 9:00 am, 12:00 am and 17:00 pm))
- Forced expiratory flow 25-75(Baseline)
- Quality of life related to cough(Baseline)
- Ease of coughing up(During the first exacerbation after recruitment)
- Sputum colour(During the first exacerbation after recruitment)
- Exacerbation frequency(12 months before enrollement)
- Sputum concentration (% solids) during the first exacerbation after recruitment(1 day)
- Impact of cough and sputum symptoms of everyday life(Baseline)
- Breathlessness(Baseline)
- Sputum concentration (% solids) one month after the first exacerbation after recruitment(1 day)
- Forced expiratory volume at 1 second(Baseline)
- Forced vital capacity(Baseline)