Clinical trial NCT05145894: Differentiation of Asthma/COPD Exacerbation and Stable State Using Automated Lung Sound Analysis With LungPass Device
Official title: Differentiation of Asthma/COPD Exacerbation and Stable State Using Automated Lung Sound Analysis With LungPass Device
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Asthma
COPD
Keywords: Lung sound analysis
Asthma Exacerbation
COPD Exacerbation
Lead sponsor: Healthy Networks
Sponsor class: INDUSTRY
Collaborators: name: Belarusian Medical Academy of Post-Graduate Education
name: University of Manchester
First posted: 2021-12-06
Enrollment: 200
Sex: ALL
Minimum age (years): 3
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

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.

Primary outcomes:
measure: Accuracy of asthma exacerbation detection by lung sounds
timeFrame: 30.09.2021-30.09.2022
measure: Accuracy of COPD exacerbation detection by lung sounds
timeFrame: 30.09.2021-30.09.2022
Secondary outcomes:
measure: Lung sounds and symptoms correlation in patients with asthma exacerbation
timeFrame: 30.09.2021-30.09.2022
measure: Lung sounds and symptoms correlation in patients with COPD exacerbation
timeFrame: 30.09.2021-30.09.2022
Other outcomes:
measure: Accuracy of asthma exacerbation detection by LungPass App output
timeFrame: 30.09.2021-30.09.2022
measure: Accuracy of COPD exacerbation detection by LungPass App output
timeFrame: 30.09.2021-30.09.2022
Locations:
city: Minsk
country: Belarus
facility: Minsk Clinical Phthisiopulmonology Center
Study officials:
affiliation: CEO
name: Helena Binetskaya
role: STUDY_DIRECTOR
References: