A Pilot Study to Evaluate the Use of the MN4000 for Treatment of Cystic Fibrosis (CF) and Motor Neuron Disease (MND) Patients in the Home Setting
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Patient / Caregiver Satisfaction Scores
研究概览
简要总结
The study was a non-randomized open label pilot study. It was an observational design conducted at one (1) site in the US. All enrolled subjects received treatment with the MN4000.
This pilot study evaluated subject satisfaction with the therapy and adherence to the therapy during the 90-day treatment period, and also collected clinical outcome data. Outcomes were assessed before, during and after the MN4000 treatment period.
详细描述
The study was a non-randomized open label pilot study. It was an observational design conducted at one (1) site in the US. All enrolled subjects received treatment with the MN4000.
This pilot study evaluated subject satisfaction with the therapy and adherence to the therapy during the 90-day treatment period, and also collected clinical outcome data. Outcomes were assessed before, during and after the MN4000 treatment period. The study did not include a control group. This pilot study was designed to provide initial information that could inform decisions for future larger-scale studies.
Ten (10) patients total were enrolled from CF and NMD clinics. Eligible subjects were adult patients who were able to perform MN4000 therapy using a mouthpiece and who met all inclusion and none of the exclusion criteria.
All patients received therapy with the MN4000 following the labeled instructions for the device.
The MN4000 is an airway clearance and lung expansion therapy device that has been cleared to market by the FDA as The MetaNeb® System for Homecare environment, for clearance of pulmonary secretions and for treatment or prevention of pulmonary atelectasis. It is a Class II device, cleared to market on March 17, 2016 under premarket notification 510(k) K151689 as The MetaNeb® 4 System with application for homecare environment. It is commercially marketed as the MN4000. The device consists of a pneumatic compressor and an air pulse generator that delivers CHFO and CPEP to;
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
- •Documented diagnosis of CF or MND
- •Age ≥ 18 years
- •Signed informed consent
排除标准
- •Requirement for continuous mechanical ventilation
- •Anticipated requirement for hospitalization within the next three months
- •History of pneumothorax within past 6 months
- •History of hemoptysis requiring embolization within past 12 months
- •Inability to perform MN4000 therapy using a mouthpiece (e.g. inability to create adequate mouth seal)
- •Inability to perform MN4000 therapy as directed
- •Inability or unwillingness to complete study visits or provide follow-up data as required by the study protocol
研究组 & 干预措施
Home based airway clearance with Metaneb
Patients with CF and MND who required regular home airway clearance therapy were enrolled to use the Metaneb device in the home setting.
The MN4000 is an airway clearance and lung expansion therapy device that has been cleared to market by the FDA as The MetaNeb® System for Homecare environment, for clearance of pulmonary secretions and for treatment or prevention of pulmonary atelectasis. It is a Class II device, cleared to market on March 17, 2016 under premarket notification 510(k) K151689 as The MetaNeb® 4 System with application for homecare environment.
干预措施: MN 4000 (Device)
结局指标
主要结局
Patient / Caregiver Satisfaction Scores
时间窗: 90 days
The primary efficacy variable was patient and/or caregiver satisfaction with therapy, as evaluated using a Therapy Use Rating Questionnaire. The questionnaire was used to assess change in satisfaction or effectiveness on a variety of parameters. The satisfaction score was completed by the patient, if possible. Some of the patients in this study had Motor Neuron Disease. This disease can compromise the ability of the patient to interact and to respond to questions. In situations where patients could not respond, caregivers were asked to respond on their behalf.
次要结局
- ALS-Functional Rating Scale (ALS-FRS)(90 days)
- Number of Participants With Exacerbation of Pulmonary Disease(90 days)
- Mean Percentage Adherence to Prescribed Treatment Regimen(90 days)
- PCF(90 days)
- Cystic Fibrosis Questionnaire - Revised (CFQ-R)(90 days)
- FEV1 (% Predicted)(90 days)
- FVC (% Predicted)(90 days)
- FVC (Actual)(90 days)
- FEV1 (Actual)(90 days)
- FEV1/FVC Ratio(90 days)
- SVC (Actual)(90 days)
- SVC (% Predicted)(90 days)
- SpO2(90 days)
- Maximal Inspiratory Pressure (MIP)(90 days)