NCT02563197已完成1 期
An Open, Multi-center Study to Measure Inhaled Flow Rates Generated by Non-CF Bronchiectasis Patients for the T-326 Inhaler
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Bayer
- 入组人数
- 33
- 试验地点
- 10
- 主要终点
- Peak inspiratory flow (L/min)
研究概览
简要总结
Study should show feasibility of the device for drug delivery into the lung independently of the severity of impaired lung function.
详细描述
The aim of the study is to measure inspiratory profiles of patients with non-Cystic fibrosis bronchiectasis using the breath activated T-326 Inhaler.
The following parameters will be derived from the inspiratory profiles:
- Peak Inspiratory Flow (PIF, in L/min)
- Inspiratory Volume (V, in L)
- Inspiratory Time (t, in s).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- •Established diagnosis of non-cystic fibrosis bronchiectasis, confirmed and documented by high resolution computed tomography (HRCT) or magnetic resonance tomography (MRT)
- •Ability to reproducibly perform spirometry according to American Thoracic Society/European Respiratory Society criteria
- •Clinically stable in the opinion of the investigator at the time of the study visit.
- •Male and female patients ≥ 18 years of age.
排除标准
- •Pulmonary exacerbation (as judged by the investigator, based on the clinical condition of the subject and taking into account e.g., febrile infection of the lung, relevant decrease in Forced expiratory volume in the first second (FEV1) value, increased sputum production, sputum purulence, recent hospitalization) at study visit or within the preceding six (6) weeks.
- •History of lung transplant.
- •Recent significant hemoptysis (≥ 300 mL or requiring blood transfusion) in the preceding six (6) weeks before screening.
- •Established diagnosis of bronchial asthma.
- •Established diagnosis of cystic fibrosis.
- •Proof of any relevant medical finding or disease in the last three (3) months which might interfere with participation in the study or patient safety (e.g. pneumothorax, uncontrolled hypertension, uncontrolled cardiac arrhythmia, myocardial infarction, cerebral vascular accident).
- •A relevant disease that is considered to interfere with the study results is any disease that, except for the impairment of lung function, interferes with the patient's ability to inhale from the device. For example, COPD per se is usually not considered as a reason for patient exclusion, unless coughing or obliteration of the upper airways with sputum interferes with the patient's ability to inhale from the device.
- •Relevant surgical history in the last 3 months (e.g., but not limited to abdominal, thoracic, ocular or brain surgery).
- •History or evidence of lung resection, thoracotomy, known aneurysm and severe scoliosis.
- •Pregnancy.
结局指标
主要结局
Peak inspiratory flow (L/min)
时间窗: Visit 2 (1-14 days after screening visit 1)
次要结局
- Inspiratory volumes (V in L)(Visit 2 (1-14 days after screening visit 1))
- Inspiratory time (t in s)(Visit 2 (1-14 days after screening visit 1))
研究者
研究点 (10)
Loading locations...
相似试验
已完成
不适用
Comparative Study of Error Rates Between ELLIPTA® Dry Powder Inhaler (DPI) and Other DPIsPulmonary Disease, Chronic ObstructiveNCT03114969GlaxoSmithKline450
终止
2 期
Acute Effects of Inhaled Treprostinil in Fontan PatientsCongenital Heart DiseaseNCT02769624Children's Hospital Medical Center, Cincinnati15
已完成
不适用
COPD Aerosol Study Comparing the Efficacy of Nebulizers Versus Dry Powder InhalersCOPD ExacerbationNCT02291016University of Tennessee Graduate School of Medicine7
Unknown
不适用
Clinical and Medico-economic Validation of the HEPHAI Solution.Asthma COPDNCT06099145Hephai238
终止
2 期
Trimodal Lung-Sparing Treatment of Pleural MesotheliomaPleural MesotheliomaNCT00859495Columbia University9