Differentiation of Asthma/COPD Exacerbation and Stable State Using Automated Lung Sound Analysis With LungPass Device
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Accuracy of COPD exacerbation detection by lung sounds
研究概览
简要总结
This observational study evaluates whether lung sound analysis with LungPass device can be used to differentiate exacerbation and stable state asthma and COPD.
详细描述
This is a prospective observational study comprised patients with moderate or severe COPD or asthma exacerbation in primary care settings. Patients will be examined twice - during an exacerbation of the disease and in a stable phase. Patients will undergo routine clinical examination including lung auscultation with conventional stethoscope and LungPass device. Moreover, symptoms and anamnesis data, results of symptoms questionnaires (CAT for COPD and ACQ-5 for asthma), result of diagnostic questionnaire from the LungPass App, spirometry data, serum procalcitonin (for COPD patients), C-reactive protein, white blood cell count and blood eosinophil count, results of sputum cytology examination, Х-ray results (if carried out according to indications) will be collected.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 3 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •For COPD patients:
- •Patients able and willing to sign an informed consent to participate in the study;
- •Patient is aged 40 years or older with a smoking history of ≥10 pack years;
- •Patients with COPD confirmed previously by a detailed medical history and examination;
- •Patients presenting with moderate or severe exacerbation of chronic obstructive pulmonary disease.
- •Patient is treated by a monotherapy long-acting muscarinic antagonist (LAMA), or LAMA plus long acting beta2-agonist (LABA), or inhaled corticosteroid (ICS) plus LABA, or LAMA plus LABA plus ICS.
- •For asthma patients:
- •Patients able and willing to sign an informed consent to participate in the study;
- •Patient is aged 3 years or older;
- •Patients with asthma confirmed previously by a detailed medical history and examination;
- •Patients presenting with moderate or severe exacerbation of asthma;
- •Patient is treated by a monotherapy ICS or ICS plus LABA or other controllers.
排除标准
- •Age up to 3 years for asthma patients and up to 40 years for COPD patients;
- •Patient refusal to participate in the study;
- •Patients with subcutaneous emphysema, with damaged skin on the surface of the chest, with drainage in the pleural space, patients undergoing mechanical ventilation;
- •Patients with asthma-COPD overlap or presence of other known chronic lung conditions such tuberculosis, cystic fibrosis or clinically significant bronchiectasis;
- •Mental illness, other known acute diseases or known chronic decompensated diseases, such as a known active malignancy or severe heart failure, other known ongoing infection.
结局指标
主要结局
Accuracy of COPD exacerbation detection by lung sounds
时间窗: 30.09.2021-30.09.2022
Accuracy of identifying acute exacerbation of chronic obstructive pulmonary disease by abnormal lung sounds detected with LungPass device.
Accuracy of asthma exacerbation detection by lung sounds
时间窗: 30.09.2021-30.09.2022
Accuracy of identifying acute exacerbation of asthma by abnormal lung sounds detected with LungPass device.
次要结局
- Lung sounds and symptoms correlation in patients with COPD exacerbation(30.09.2021-30.09.2022)
- Lung sounds and symptoms correlation in patients with asthma exacerbation(30.09.2021-30.09.2022)