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

NCT ID: NCT05145894

Last Updated: 2021-12-06

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 200 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2021-09-30
• Study Completion Date: 2022-09-30

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.

Conditions

Asthma; COPD

Keywords

Lung sound analysis; Asthma Exacerbation; COPD Exacerbation

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

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

Lung auscultation with LungPass device (electronic auscultation)

Intervention Type: DEVICE

Lung auscultation with electronic stethoscope

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

Lung auscultation with LungPass device (electronic auscultation)

Intervention Type: DEVICE

Lung auscultation with electronic stethoscope

Interventions

Lung auscultation with LungPass device (electronic auscultation)

Lung auscultation with electronic stethoscope

Intervention Type: DEVICE

Eligibility Criteria

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.

• Minimum Eligible Age: 3 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Belarusian Medical Academy of Post-Graduate Education

OTHER

Sponsor Role: collaborator

University of Manchester

OTHER

Sponsor Role: collaborator

Healthy Networks

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Helena Binetskaya

Role: STUDY_DIRECTOR

CEO

Locations

Minsk Clinical Phthisiopulmonology Center

Minsk, , Belarus

Site Status: RECRUITING

Countries

Belarus

Central Contacts

Helena Binetskaya

Role: CONTACT

Phone: +375333130806

Email: helena@lungpass.com

Olga Kharevich, MD, PhD

Role: CONTACT

Phone: +375298649803

Email: o_harevich@tut.by

Facility Contacts

Elena Loban, MD

Role: primary

Other Identifiers

№ 4-3/YH-2056/LP05

Identifier Type: -

Identifier Source: org_study_id