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Differentiation of Asthma/COPD Exacerbation and Stable State Using Automated Lung Sound Analysis With LungPass Device

Differentiation of Asthma/COPD Exacerbation and Stable State Using Automated Lung Sound Analysis With LungPass Device

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05145894
Enrollment
200
Registered
2021-12-06
Start date
2021-09-30
Completion date
2022-09-30
Last updated
2021-12-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Asthma, COPD

Keywords

Lung sound analysis, Asthma Exacerbation, COPD Exacerbation

Brief summary

This observational study evaluates whether lung sound analysis with LungPass device can be used to differentiate exacerbation and stable state asthma and COPD.

Detailed description

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.

Interventions

Lung auscultation with electronic stethoscope

Sponsors

Belarusian Medical Academy of Post-Graduate Education
CollaboratorOTHER
University of Manchester
CollaboratorOTHER
Healthy Networks
Lead SponsorINDUSTRY

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
3 Years to No maximum
Healthy volunteers
No

Inclusion criteria

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.

Exclusion criteria

* 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.

Design outcomes

Primary

MeasureTime frameDescription
Accuracy of asthma exacerbation detection by lung sounds30.09.2021-30.09.2022Accuracy of identifying acute exacerbation of asthma by abnormal lung sounds detected with LungPass device.
Accuracy of COPD exacerbation detection by lung sounds30.09.2021-30.09.2022Accuracy of identifying acute exacerbation of chronic obstructive pulmonary disease by abnormal lung sounds detected with LungPass device.

Secondary

MeasureTime frameDescription
Lung sounds and symptoms correlation in patients with asthma exacerbation30.09.2021-30.09.2022Correlation between the presence of pathological pulmonary sounds and the presence of symptoms of asthma exacerbation
Lung sounds and symptoms correlation in patients with COPD exacerbation30.09.2021-30.09.2022Correlation between the presence of pathological pulmonary sounds and the presence of symptoms of COPD exacerbation

Other

MeasureTime frameDescription
Accuracy of asthma exacerbation detection by LungPass App output30.09.2021-30.09.2022Аccuracy 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)
Accuracy of COPD exacerbation detection by LungPass App output30.09.2021-30.09.2022Аccuracy 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)

Countries

Belarus

Contacts

Primary ContactHelena Binetskaya
helena@lungpass.com+375333130806
Backup ContactOlga Kharevich, MD, PhD
o_harevich@tut.by+375298649803

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026