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

Asthma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05145894
• Other study ID #: ? 4-3/YH-2056/LP05
• Status: Recruiting
• Start date: September 30, 2021
• Est. completion date: September 30, 2022

Study information

• Verified date: November 2021
• Source: Healthy Networks
• Contact: Helena Binetskaya
• Phone: +375333130806
• Email: helena[@]lungpass.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: September 30, 2022
• Est. primary completion date: September 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 3 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Asthma
• COPD
• Respiratory Sounds

Intervention

Device:
• Lung auscultation with LungPass device (electronic auscultation)
Lung auscultation with electronic stethoscope

Locations

Country	Name	City	State
Belarus	Minsk Clinical Phthisiopulmonology Center	Minsk

Sponsors (3)

Lead Sponsor	Collaborator
Healthy Networks	Belarusian Medical Academy of Post-Graduate Education, University of Manchester

Country where clinical trial is conducted

Belarus, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Accuracy of asthma exacerbation detection by LungPass App output	?ccuracy 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)	30.09.2021-30.09.2022
Other	Accuracy of COPD exacerbation detection by LungPass App output	?ccuracy 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
Primary	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
Primary	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	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
Secondary	Lung sounds and symptoms correlation in patients with COPD exacerbation	Correlation between the presence of pathological pulmonary sounds and the presence of symptoms of COPD exacerbation	30.09.2021-30.09.2022