Efficacy of Nebulised 5% Hypertonic Saline in Children With Chronic Suppurative Lung Disease
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 46
- 试验地点
- 1
- 主要终点
- Change in the Short Parent-proxy cough quality of life (PC-QOL) score
研究概览
简要总结
To determine the efficacy of nebulized 5% hypertonic saline on cough severity and quality of life, in children with non-CF CSLD.
Secondary Aims:
To determine the:
- Efficacy of nebulized 5% hypertonic saline on airway microbiome, pulmonary exacerbation rate, healthcare utilization, and rescue antibiotics.
- Efficacy of nebulized 5% hypertonic saline on lung function
- Adverse effects of nebulized 5% hypertonic saline in children
详细描述
Primary Aim:
To determine the efficacy of nebulized 5% hypertonic saline on cough severity and quality of life, in children with non-CF CSLD.
Here the investigators will be using validated pediatric cough questionnaires to asses this. Patients will answer these questionnaires at first recruitment ( -1 mth), at randomization (0 month) and after 3 mths of use of the nebulized study drug (+ 3 mths)
Secondary Aims:
To determine the:
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
Double-blind
入排标准
- 年龄范围
- 3 Months 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients < 18 years old
- •Followed up in the paediatric respiratory clinic of UMMC with a diagnosis of CSLD
排除标准
- •Incomplete data or refusal to participate
- •Unwell and/or unable to stop HS and/or antibiotics of any preparation other than azithromycin ( EOD
- •On supplementary oxygen/home ventilation
- •Poorly controlled asthma (as in the GINA guidelines) or bronchoconstriction that precedes the use of hypertonic saline.
- •Oral antibiotics for less than 4 weeks before randomization for medication.
- •Fall in PEFR > 20% post 5% HS challenge test or a positive HS challenge test in young children, as mentioned below.
研究组 & 干预措施
5% Hypertonic saline
5% hypertonic saline nebuliser 4 mls twice in a day for 3 months
干预措施: Nebulized 5% Hypertonic saline (Drug)
Placebo
0.9% saline nebuliser 4 mls twice in a day for 3 months
干预措施: Nebulized 5% Hypertonic saline (Drug)
结局指标
主要结局
Change in the Short Parent-proxy cough quality of life (PC-QOL) score
时间窗: at -1 month of randomization, at day 1 of randomization, at 3 months of use of study drug
Short PCQOL: This is a validated cough quality-of-life(QoL) questionnaire for parents of children with chronic cough, with a translated Malay version. Minimal Important Difference(MID) of 0.9 has been found in the validation study. The answers are on a Likert scale from 1 (every time) to 7( none). A lower score denotes a lower quality of life. The patients will answer either the English or the translated Malay version
Change in the Chronic Cough-specific QoL(CC-QOL) score
时间窗: at -1 month of randomization, at day 1 of randomization, at 3 months of use of study drug
Chronic cough-specific QOL: This is a validated cough QoL questionnaire to be answered by children 7 years till 18 years old with a MID of about 1.1. The answers are in a Likert scale from 1 ( every time) to 7( none). A lower score denotes a lower quality of life. The patients will answer either the English or the translated Malay version
次要结局
- Cough diary(at -1 month of randomization, at day 1 of randomization, at 3 months of use of study drug)
- Number of Adverse events(At day 1 of randomization, at 3 months of use of study drug)
- Airway microbiome(At day 1 of randomization, at 3 months of use of study drug)
- Number of Exacerbations(at -1 month of randomization, at day 1 of randomization, at 3 months of use of study drug)
- Number of Unscheduled Health Care Visits(at -1 month of randomization, at day 1 of randomization, at 3 months of use of study drug)
- No of episodes of rescue antibiotics(at -1 month of randomization, at day 1 of randomization, at 3 months of use of study drug)
- FEV1(At day 1 of randomization, at 3 months of use of study drug)
- FVC(At day 1 of randomization, at 3 months of use of study drug)
- FEF 25-75%(At day 1 of randomization, at 3 months of use of study drug)
- PEFR ( pre and post), if possible(at -1 month of randomization, at day 1 of randomization, at 3 months of use of study drug)
研究者
Anna Marie Nathan
Consultant and Professor
University of Malaya