A Multicenter, Human Factors Validation Study in Cystic Fibrosis Patients Aged 6 Years and Older to Evaluate the User Interface of TOBI® Podhaler™ (Tobramycin Inhalation Powder) Using Placebo Capsules
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- Mylan Inc.
- 入组人数
- 47
- 试验地点
- 9
- 主要终点
- Number of Participants With Critical Use Errors and Close Calls Associated With the Simulated Inhalation of One Dose Using TOBI Podhaler
研究概览
简要总结
The purpose of this study is to validate the user interface of TOBI Podhaler by establishing that the product can support safe and effective use for the intended users
详细描述
The objective is to conduct a human factors validation study to demonstrate that the user interface of TOBI® Podhaler™ can support safe and effective use for the intended users. The human factors validation study will be conducted in patients with cystic fibrosis aged 6 years and older under simulated yet representative of realistic use conditions where patients with no prior training or use of TOBI® Podhaler™ will be asked to inhale the contents of placebo capsules through the Podhaler device. Due to the use of placebo capsules, the study is considered an interventional clinical study and will be conducted accordingly. The study is an open label, un-blinded, non-randomized study which consists of one visit.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 6 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Written informed consent or, parent/guardian consent and where applicable pediatric assent, must be obtained before any assessment is performed
- •Male and female subjects aged 6 years and older
- •Confirmed diagnosis of CF by one or more of the following tests for CF as documented in the patient's medical history : (1) quantitative pilocarpine iontophoresis sweat chloride test of > 60 mmol/L or 60 mEq/L, (2) genotype with identifiable CF-causing mutations on both chromosomes, (3) an abnormal nasal transepithelial potential difference characteristic of CF
- •FEV1 value must be at least 25% of normal predicted values for age, sex, and height as documented in the patient's medical history (historical values within 3 months can be used for this criterion).
- •Able to comply with all protocol requirements
- •Clinically stable in the opinion of the investigator
排除标准
- •Subjects currently enrolled in studies that are not considered as observational non-investigational studies
- •Subjects or caregivers who have used the Podhaler device previously
- •Hemoptysis more than approximately 60 mL at any time within 30 days prior to enrollment
- •History of hypersensitivity to the inhaled placebo dry powder (DSPC and/or calcium chloride powder)
- •Signs and symptoms of acute pulmonary disease, e.g. pneumonia, pneumothorax, bronchospasm, acute respiratory infection
- •Clinically significant conditions or findings at enrollment that might interfere with the accurate and valid assessment of this study
- •Subjects or caregivers who are considered potentially unreliable or considered unlikely to be compliant within the trial
- •Pregnant women
研究组 & 干预措施
Open-Label Placebo
One dose (4 capsules) of placebo
干预措施: Placebo (Drug)
Open-Label Placebo
One dose (4 capsules) of placebo
干预措施: Tobi Podhaler (Device)
结局指标
主要结局
Number of Participants With Critical Use Errors and Close Calls Associated With the Simulated Inhalation of One Dose Using TOBI Podhaler
时间窗: 1 Day
Critical use errors and close calls for the following: placing of capsule into the top of the mouthpiece, failure to replace mouthpiece, failure to adequately pierce capsule, failure to release before inhaling, multiple piercing of capsule, exhalation into mouthpiece, inadequate seal around mouthpiece, inadequate inhalation technique, failure to use reserve device when capsule not adequately pierced, failure to administer 4 capsules per dose, swallowing of capsule
次要结局
未报告次要终点