Comparison of the Tolerability of Two Formulations of Hypertonic Saline in Cystic Fibrosis Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Comparison of the judgement on global pleasure of the inhalation between the two treatment groups
研究概览
简要总结
The purpose of this study is to compare the tolerability and acceptability of a formulation containing Hypertonic saline 7% (HS) alone and a formulation containing HS and Hyaluronic acid 0.1% in a population of Cystic Fibrosis (CF) patients who already showed poor tolerance to HS.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 8 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •diagnosis of Cystic Fibrosis (genotyping and sweat test)
- •> 8 year-old
- •clinically and therapeutically stable disease in the last 30 days;
- •Forced Expiratory Volume in one second (FEV1) ≥ 50% of predicted value;
- •intolerance (cough, throat irritation, saltiness) to previous administration of 5.8% hypertonic saline solution.
排除标准
- •decrease in FEV1 >15% after first inhalation of hypertonic saline;
- •Burkholderia cepacia infection;
- •infective exacerbation requiring antibiotic treatment in the 15 days preceding enrolment;
- •patient non compliant to standard therapy;
- •Lung transplant;
- •Patient unable to perform reproducible spirometry;
- •Intolerance to β2 bronchodilators;
- •Concurrent enrolment in other clinical trials;
- •Plasmatic creatinine and transaminases more than twice the normal values.
结局指标
主要结局
Comparison of the judgement on global pleasure of the inhalation between the two treatment groups
时间窗: The outcome measure was assessed at day 1, day 7, day 14, day 21, and day 28 of the four-weeks treatment period. For each time-point we operated a comparison between the two groups.
A judgment on acceptability and global pleasure of the inhalation was weekly reported by patients on a diary, expressed on a 1-10 scale: a score lower than 6 was considered unfavourable.
Comparison of the symptom cough between the two treatment groups
时间窗: The outcome measure was assessed at day 1, day 7, day 14, day 21, and day 28 of the four-weeks treatment period. For each time-point we operated a comparison between the two groups.
A judgement on the symptom cough, one of the most important causes of HS intolerance and poor compliance to HS treatment, was weekly reported by patients on a diary, as assessed on a scale of four grades (absent, mild, moderate, severe).
Comparison of the sensation of saltiness between the two treatment groups
时间窗: The outcome measure was assessed at day 1, day 7, day 14, day 21, and day 28 of the four-weeks treatment period. For each time-point we operated a comparison between the two groups.
A judgement on the sensation of saltiness, one of the most important causes of HS intolerance and poor compliance to HS treatment, was weekly reported by patients on a diary, as assessed on a scale of four grades (absent, mild, moderate, severe).
Comparison of the sensation of throat irritation between the two treatment groups
时间窗: The outcome measure was assessed at day 1, day 7, day 14, day 21, and day 28 of the four-weeks treatment period. For each time-point we operated a comparison between the two groups.
A judgement on the sensation of throat irritation, one of the most important causes of HS intolerance and poor compliance to HS treatment, was weekly reported by patients on a diary, as assessed on a scale of four grades (absent, mild, moderate, severe).
次要结局
- Comparison of Delta FEV1 between the two treatment groups(day 1 and day 28 of the four-weeks treatment)