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| Name | Class |
|---|---|
| Belarusian Medical Academy of Post-Graduate Education | OTHER |
| University of Manchester | OTHER |
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This observational study evaluates whether lung sound analysis with LungPass device can be used to differentiate exacerbation and stable state asthma and COPD.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Asthma | Asthma patients aged 3 years and older with confirmed asthma diagnosis treated by a monotherapy ICS or ICS plus LABA or other controllers and presenting with moderate or severe disease exacerbation |
| |
| COPD | COPD patients aged 40 years and older with confirmed COPD diagnosis 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 and presenting with moderate or severe disease exacerbation |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lung auscultation with LungPass device (electronic auscultation) | Device | Lung auscultation with electronic stethoscope |
|
| Measure | Description | Time Frame |
|---|---|---|
| Accuracy of asthma exacerbation detection by lung sounds | Accuracy of identifying acute exacerbation of asthma by abnormal lung sounds detected with LungPass device. | 30.09.2021-30.09.2022 |
| Accuracy of COPD exacerbation detection by lung sounds | Accuracy of identifying acute exacerbation of chronic obstructive pulmonary disease by abnormal lung sounds detected with LungPass device. | 30.09.2021-30.09.2022 |
| Measure | Description | Time Frame |
|---|---|---|
| Lung sounds and symptoms correlation in patients with asthma exacerbation | Correlation between the presence of pathological pulmonary sounds and the presence of symptoms of asthma exacerbation | 30.09.2021-30.09.2022 |
| Lung sounds and symptoms correlation in patients with COPD exacerbation |
| Measure | Description | Time Frame |
|---|---|---|
| Accuracy of asthma exacerbation detection by LungPass App output | Аccuracy of identifying acute exacerbation of chronic obstructive pulmonary disease and asthma by final LungPass App output which based on abnormal lung sounds detected with LungPass device together with symptoms collected using a questionnaire in the LungPass app*. * Final LungPass App output is possible patient condition (asthma/asthma exacerbation, COPD/COPD exacerbation, bronchitis, pneumonia, etc) |
Inclusion Criteria:
For COPD patients:
For asthma patients:
Exclusion Criteria:
for COPD: 40 years or older for asthma: 3 years or older
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Patients will be recruited upon presentation with a moderate or severe COPD or asthma exacerbation in primary care settings.
It is planned to recruit 100 patients with asthma and 100 patients with COPD at the initial study stage. The final calculation of the sample size will be carried out after receiving the preliminary results of the study. After that, the sample size will be adjusted.
Patients will be examined twice - during an exacerbation of the disease and in a stable phase.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Helena Binetskaya | Contact | +375333130806 | helena@lungpass.com | |
| Olga Kharevich, MD, PhD | Contact | +375298649803 | o_harevich@tut.by |
| Name | Affiliation | Role |
|---|---|---|
| Helena Binetskaya | CEO | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Minsk Clinical Phthisiopulmonology Center | Recruiting | Minsk | 220026 | Belarus |
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| ID | Term |
|---|---|
| D001249 | Asthma |
| D029424 | Pulmonary Disease, Chronic Obstructive |
| ID | Term |
|---|---|
| D001982 | Bronchial Diseases |
| D012140 | Respiratory Tract Diseases |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
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Correlation between the presence of pathological pulmonary sounds and the presence of symptoms of COPD exacerbation |
| 30.09.2021-30.09.2022 |
| 30.09.2021-30.09.2022 |
| Accuracy of COPD exacerbation detection by LungPass App output | Аccuracy of identifying acute exacerbation of chronic obstructive pulmonary disease by final LungPass App output which based on abnormal lung sounds detected with LungPass device together with symptoms collected using a questionnaire in the LungPass app*. * Final LungPass App output is possible patient condition (asthma/asthma exacerbation, COPD/COPD exacerbation, bronchitis, pneumonia, etc) | 30.09.2021-30.09.2022 |
| D012130 |
| Respiratory Hypersensitivity |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |