NCT00251056已完成2 期
A Phase IIa Randomised, Open Label, Dose Response Study to Determine the Optimum Dose of Dry Powder Mannitol Required to Generate Clinical Improvement In Patients With Cystic Fibrosis
Syntara12 个研究点 分布在 2 个国家目标入组 48 人开始时间: 2005年10月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 48
- 试验地点
- 12
- 主要终点
- FEV1
研究概览
简要总结
Many cystic fibrosis patients die of lung failure caused by repeated lung infections from thick, sticky mucus. Past studies have shown Bronchitol inhalation may help to facilitate the clearance of mucus by altering its rheology and replenishing the airway surface liquid layer in these patients, thereby enhancing the shift of stagnant mucus from the lungs. The study aim is to determine the optimal dose of mannitol to generate clinical improvement in patients with cystic fibrosis.
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
- None
入排标准
- 年龄范围
- 7 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 (sweat test/genotype)
- •7 years or older
- •FEV1 between 40% and 90% of predicted for height, age and gender.
- •Able to perform acceptable-quality spirometry
- •Clinically stable in the week up to study entry
- •No additional antibiotics or additional oral steroids for a period of 14 days before study entry (routine antibiotics permitted)
- •Exclusion Criteria
- •Currently active asthma
- •Subjects colonized with Burkholderia cepacia or MRSA
- •Considered "terminally ill" or listed for transplantation
- •Requiring home oxygen or assisted ventilation
- •Concurrent illness that in the investigators opinion may contribute to an increased and unacceptable risk if the subject was enrolled in the study (e.g. significant varicies, portal hypertension, cor pulmonale)
- •Significant episode of haemoptysis (>60 mLs) in the previous 12 months
- •Heart attack or stroke in last 3 months
- •Known aortic or cerebral aneurysm
- •Subjects who are breast feeding or pregnant.
- •At risk females unwilling to use appropriate contraception to prevent pregnancy during the course of the study
- •Subjects who have participated in another investigative drug study parallel to, or within 4 weeks of study entry.
- •Known intolerance to mannitol or unable to take any form of bronchodilator medications.
- •Uncontrolled hypertension, systolic BP > 200 or diastolic BP> than 100
- •Concurrent use of beta blocker medication
- •Concurrent use of hypertonic saline
- •Concurrent use of other pharmacological mucolytic agents other than Pulmozyme
- •Concurrent use of other pharmacological mucolytic agents including Pulmozyme
排除标准
- 未提供
研究组 & 干预措施
3
Active Comparator
干预措施: mannitol (Drug)
1
Active Comparator
干预措施: mannitol (Drug)
2
Active Comparator
干预措施: mannitol (Drug)
4
Active Comparator
干预措施: mannitol (Drug)
结局指标
主要结局
FEV1
时间窗: 2 weeks
FVC
时间窗: 2 weeks
次要结局
- sputum microbiology(2 weeks)
- safety(2 weeks)
- other measures of lung function(various)
- respiratory symptoms(2 weeks)
- sputum clearance and cough(2 weeks)
- QOL(2 weeks)
研究者
研究点 (12)
Loading locations...
相似试验
已完成
2 期
Efficacy and Safety Study of Inhaled Glutathione in Cystic Fibrosis PatientsCystic FibrosisNCT00506688Mukoviszidose Institut gGmbH153
终止
3 期
Tobramycin Inhalation Powder (TIP) in Cystic Fibrosis SubjectsCystic FibrosisNCT00125346Novartis98
已完成
不适用
Study About Complications of Totally Implanted Venous Access Devices (TIVADs) in People With Cystic Fibrosis (CF)Cystic FibrosisNCT00670579University of Florence80
已完成
1 期
Safety, Pharmacokinetic and Pharmacodynamic Study of MP-376 in Patients With Cystic FibrosisCystic FibrosisNCT00503490Amgen40
已完成
2 期
Safety, Tolerability and Efficacy of MP-376 Given for 28 Days to Cystic Fibrosis (CF) PatientsCystic Fibrosis (CF)NCT00677365Amgen151