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

• Conditions: Asthma; COPD
• Interventions: Device: Lung auscultation with LungPass device (electronic auscultation)

• Registration Number: NCT05145894
• Lead Sponsor: Healthy Networks

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.

Study Timeline

• Study Start: 2021-09-30
• Study First Submitted: 2021-10-21
• Status Verified: 2021-11
• Study First Submitted QC: 2021-11-23
• Last Update Submitted: 2021-11-23
• Study First Posted: 2021-12-06
• Last Update Posted: 2021-12-06
• Primary Completion: 2022-09-30
• Study Completion: 2022-09-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 200

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Asthma	Lung auscultation with LungPass device (electronic auscultation)	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	Lung auscultation with LungPass device (electronic auscultation)	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

Primary Outcome Measures

Name	Time	Method
Accuracy of COPD exacerbation detection by lung sounds	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	30.09.2021-30.09.2022	Accuracy of identifying acute exacerbation of asthma by abnormal lung sounds detected with LungPass device.

Secondary Outcome Measures

Name	Time	Method
Lung sounds and symptoms correlation in patients with COPD exacerbation	30.09.2021-30.09.2022	Correlation between the presence of pathological pulmonary sounds and the presence of symptoms of COPD exacerbation
Lung sounds and symptoms correlation in patients with asthma exacerbation	30.09.2021-30.09.2022	Correlation between the presence of pathological pulmonary sounds and the presence of symptoms of asthma exacerbation

Trial Locations

Locations (1)

Minsk Clinical Phthisiopulmonology Center; 🇧🇾 Minsk, Belarus