A Multi-center, Longitudinal 12-week Pilot Study to Evaluate Cough Severity and Its Impact, Utilizing a Next Generation Cough Monitor, in Participants With Idiopathic Pulmonary Fibrosis (IPF) or Non IPF Pulmonary Fibrosis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 53
- 试验地点
- 26
- 主要终点
- Cough Count Per Hour (CC/hr) Measured Over a 24-hour Period at Baseline Visit, Week 4, Week 8, and at Day 82
研究概览
简要总结
This study is open to adults aged 18 years and older who have pulmonary fibrosis with or without a known cause (or other forms of pulmonary fibrosis).
The purpose of this study is to better understand coughing in people with pulmonary fibrosis. To do this, a wearable cough monitor called Strados Remote Electronic Stethoscope Platform (RESP) is used. This device will measure how often and how forceful coughing is in people with pulmonary fibrosis.
All participants in the study get the device. It is placed on their skin over the chest.
Participants are in the study for 3 months. During this time, they visit the study site 2 to 3 times. 4 visits are done at the participant's home by video call with the site staff.
During the study, the device measures coughing over 24 hours. This is done on 4 days. Participants fill in questionnaires about their coughing and doctors regularly check participant's lung function. A breathing test that measures how well the lungs are working is performed both in the office and during home visits. The doctors also regularly check participants' health and take note of any unwanted effects.
This study will also record patients' experiences using the cough monitor and video assisted breathing tests at visits 3, 4, 5 and 6 at home.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
Cough Count Per Hour (CC/hr) Measured Over a 24-hour Period at Baseline Visit, Week 4, Week 8, and at Day 82
时间窗: At baseline (Visit 2), Week 4 (Visit 4), Week 8 (Visit 5) and at Day 82 (Visit 6).
Cough count per hour (CC/hr) measured over a 24-hour period at baseline visit, Week 4, Week 8, and at Day 82.
次要结局
- Change From Baseline (CfB) in Cough Count Per Hour (CC/h) at Week 4, Week 8 and at Day 82(At baseline (Visit 2), Week 4, (Visit 4) Week 8 (Visit 5) and at Day 82 (Visit 6).)
- Forced Vital Capacity (FVC) at Baseline and at Week 12(At baseline (Visit 2) and at Week 12 (Visit 7).)
- Change From Baseline in Forced Vital Capacity (FVC) at Week 12(At baseline (Visit 2) and at Week 12 (Visit 7).)
- Percentage (%) of Analysable Cough Device Data Per 24-hour Recording (Feasibility of Remote Cough Data Capture)(At baseline (Visit 2), Week 4 (Visit 4), Week 8 (Visit 5) and at Day 82 (Visit 6).)
- Number of Successful Completion of All Elements of Remote Visit (Feasibility of Hybrid Study Design)(At Day 3 (Visit 3), Week 4 (Visit 4), Week 8 (Visit 5) and at Day 82 (Visit 6).)