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

NCT05145894 | Unknown DMC

• 1 other identifier: № 4-3/YH-2056/LP05
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

Asthma; COPD

Keywords

Lung sound analysis; Asthma Exacerbation; COPD Exacerbation

Outcome Measures

Primary Outcomes (2)

• 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

Secondary Outcomes (2)

• Lung sounds and symptoms correlation in patients with asthma exacerbation

  30.09.2021-30.09.2022

• Lung sounds and symptoms correlation in patients with COPD exacerbation

  30.09.2021-30.09.2022

Other Outcomes (2)

• Accuracy of asthma exacerbation detection by LungPass App output

  30.09.2021-30.09.2022

• Accuracy of COPD exacerbation detection by LungPass App output

  30.09.2021-30.09.2022

Study Arms (2)

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

Device: Lung auscultation with LungPass device (electronic auscultation)

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

Device: Lung auscultation with LungPass device (electronic auscultation)

Interventions

Lung auscultation with LungPass device (electronic auscultation) DEVICE

Lung auscultation with electronic stethoscope

Asthma; COPD

Eligibility Criteria

• Age: 3 Years+
• Gender Eligibility Details: for COPD: 40 years or older for asthma: 3 years or older
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Healthy Networks: lead
• Belarusian Medical Academy of Post-Graduate Education: collaborator
• University of Manchester: collaborator

Study Sites (1)

Minsk Clinical Phthisiopulmonology Center

Minsk, 220026, Belarus

RECRUITING

MeSH Terms

Conditions

Asthma; Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Helena Binetskaya

  CEO

  STUDY DIRECTOR

Central Study Contacts

Helena Binetskaya

CONTACT

+375333130806; helena@lungpass.com

Olga Kharevich, MD, PhD

CONTACT

+375298649803; o_harevich@tut.by

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 21, 2021
• First Posted: December 6, 2021
• Study Start: September 30, 2021
• Primary Completion: September 30, 2022
• Study Completion: September 30, 2022
• Last Updated: December 6, 2021

Record last verified: 2021-11

Locations

BE (1)