Digital Auscultation Tool - Development of an Innovative Approach - Using Modern Technologies - to Improve the Diagnosis of Rare Lung Diseases - Expanded Data Collection Idiopathic Pulmonary Fibrosis
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 274
- 试验地点
- 20
- 主要终点
- Main Study - The Percentage of Collected Auscultation Points
研究概览
简要总结
The aim of this study is the data collection for patients with IPF and symptom matched controls to create a database of lung auscultation sounds and basic patient characteristics.
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
- 45 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female patients
- •Age ≥ 45 years at the day of the study visit
- •Diagnosis:
- •For patients with confirmed Idiopathic Pulmonary Fibrosis (IPF) diagnosis - a clinical diagnosis of IPF within the last 24 months from the day of the study visit, according to the American Thoracic Society (ATS)/ European Respiratory Society (ERS) 2011 guideline [P11-07084] or
- •For the symptom matched control - patients without a IPF diagnosis but with one of the confirmed current conditions as:
- •asthma diagnosed according to GINA guidelines,
- •COPD diagnosed according to GOLD guidelines,
- •pneumonia,
- •upper respiratory tract infection, or
- •acute bronchitis.
- •Signed and dated written informed consent in accordance with Good Clinical Practice (GCP) and local legislation prior to admission to the study
排除标准
- •Any other current respiratory condition other than the pulmonary disease which qualified the patient eligibility based on inclusion criterion 3
- •Any condition, according to investigator's assessment, which will not allow the patient to comply with protocol assessments or need a legal representative
- •Patients with a history of lobectomy, pneumonectomy or lung transplant
- •Patients with a Body Mass Index (BMI) >30,0 kg/m²
- •Previous enrolment in this study
- •Women who are pregnant
结局指标
主要结局
Main Study - The Percentage of Collected Auscultation Points
时间窗: Day 1 (Visit 1)
For each participants the auscultation sound files were collected at 12 points of the body. In each defined region of the participant's body, auscultation was to be performed to maximize the sound quality according to the investigator's experience. Auscultations were recorded using a Littmann Digital Stethoscope (Model 3200) and the 3M Littmann StethAssist software on a computer provided for the study. The unit of the measure is "Percentage of auscultation points collected per participants".
次要结局
- Entire Study - Body Mass Index (BMI)(Day 1 (Visit 1))
- Entire Study - Participants Reported Symptoms of Respiratory Disease - Cough and Sputum(Day 1 (Visit 1))
- Entire Study - Smoking Status(Day 1 (Visit 1))
- Entire Study - Participants Reported Symptoms of Respiratory Disease - Dyspnoea Recorded Via a Modified Medical Research Council (MRC) Scale(Day 1 (Visit 1))
- Sub Study - The Percentage of Collected Auscultation Points(Day 1 (Visit 1))