AsthmaNCT05145894
Differentiation of Asthma/COPD Exacerbation and Stable State Using Automated Lung Sound Analysis With LungPass Device
An observational study of Asthma and COPD, run by Healthy Networks at 1 site in Belarus.
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. Read more about this study
- Who is it for?
- Ages 3 years and older
- What is being tested?
- Lung auscultation with LungPass device (electronic auscultation)
- Type of treatment
- Medical device
- How many people
- 200 participants
- Where
- 1 siteBelarus
- Study dates
- 30 Sep 2021to 30 Sep 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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.
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Belarus1 site, 1 recruiting
- Recruiting
Minsk Clinical Phthisiopulmonology Center
Minsk, 220026
Elena Loban, MD, +375296373435, e_loban@mail.ru
Elena Loban, MD
About this study
This observational study evaluates whether lung sound analysis with LungPass device can be used to differentiate exacerbation and stable state asthma and COPD.
Read the 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.
- Being tested
- Lung auscultation with LungPass device (electronic auscultation)
- Keywords
- Lung sound analysis, Asthma Exacerbation, COPD Exacerbation
- Medical subject headings
- Asthma, Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lung auscultation with LungPass device (electronic auscultation)Device
Lung auscultation with electronic stethoscope
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: Device: Lung auscultation with LungPass device (electronic auscultation) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Accuracy of asthma exacerbation detection by lung sounds
Accuracy of identifying acute exacerbation of asthma by abnormal lung sounds detected with LungPass device.
Measured: 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.
Measured: 30.09.2021-30.09.2022
Secondary outcomes (2)
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
Measured: 30.09.2021-30.09.2022
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
Measured: 30.09.2021-30.09.2022
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Dec 2021
- Study start30 Sep 2021
- Primary completion30 Sep 2022 (estimated)
- Study completion30 Sep 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AsthmaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Healthy Networks
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Belarusian Medical Academy of Post-Graduate Education, University of Manchester
- Responsible party
- Sponsor
- Investigators
- Helena Binetskaya, Study director, CEO
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05145894
- Sponsor's protocol ID
- № 4-3/YH-2056/LP05
- Status last verified
- Nov 2021
- First submitted
- 21 Oct 2021
- Last updated
- 6 Dec 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 6 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Differentiation of Asthma/COPD Exacerbation and Stable State Using Automated Lung Sound Analysis With LungPass Device
- ClinicalTrials.gov ID
- NCT05145894
- Acronym / sponsor ID
- № 4-3/YH-2056/LP05
- Keywords
- Lung sound analysis, Asthma Exacerbation, COPD Exacerbation
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Healthy NetworksIndustry (pharma, biotech, devices)
- Collaborators
- Belarusian Medical Academy of Post-Graduate Education, University of Manchester
- Study start
- 30 Sep 2021 (actual)
- Primary completion
- 30 Sep 2022 (estimated)
- Study completion
- 30 Sep 2022 (estimated)
- First posted
- 6 Dec 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Asthma | – | Device: 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 | – | Device: 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 |
Who may qualify
- Ages
- 3 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (12 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lung auscultation with LungPass device (electronic auscultation)Lung auscultation with electronic stethoscope | Device | Asthma, COPD |
Primary outcome
Accuracy of asthma exacerbation detection by lung sounds
Time frame: 30.09.2021-30.09.2022
Accuracy of identifying acute exacerbation of asthma by abnormal lung sounds detected with LungPass device.
Accuracy of COPD exacerbation detection by lung sounds
Time frame: 30.09.2021-30.09.2022
Accuracy of identifying acute exacerbation of chronic obstructive pulmonary disease by abnormal lung sounds detected with LungPass device.
2 secondary outcomes
Lung sounds and symptoms correlation in patients with asthma exacerbation
Time frame: 30.09.2021-30.09.2022
Lung sounds and symptoms correlation in patients with COPD exacerbation
Time frame: 30.09.2021-30.09.2022
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Dec 2021.
- Individual participant dataSharing planned: Undecided
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Asthma
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Helena Binetskaya study director
CEO
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Asthma and COPD, run by Healthy Networks at 1 site in Belarus.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 6 Dec 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belarus. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Helena Binetskaya (+375333130806, helena@lungpass.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Accuracy of asthma exacerbation detection by lung sounds (time frame: 30.09.2021-30.09.2022). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Dec 2021.