AsthmaNCT03894475
Non-inferiority of Portable Versus Desktop Spirometry
A study testing AioCare and Spirometer USB CPFS/D (MGC Diagnostics) in people with Asthma and COPD, run by National Institute for Tuberculosis and Lung Diseases, Poland at 1 site in Poland.
Trial summary
The investigators compared the ventilation parameters for volume and flow obtained from standard spirometry procedures from patients presently monitored and treated for asthma or chronic obstructive pulmonary disease (COPD) using AioCare (HealthUp Sp. Read more about this study
- Who is it for?
- Ages 18 years and older
- What is being tested?
- AioCare and Spirometer USB CPFS/D (MGC Diagnostics)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 62 participants
- Where
- 1 sitePoland
- Study dates
- 18 Dec 2017to 21 Jun 2018
- Phase
- Interventional
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age>18.
- Diagnosed asthma or COPD
- Signed consent to participation in the research experiment.
- Ability to comply with the spirometry protocol.
Who cannot join
- Pregnant females (based on declaration; no pregnancy tests are planned before the test).
- Recent myocardial infarction (<30 days).
- Known thoracic, aortic or cerebral aneurysm.
- Recent stroke, eye surgery, thoracic/abdominal surgery.
- Haemoptysis.
- Recent pneumothorax.
Show all 13Show fewer
- Uncontrolled hypertension.
- Pulmonary Embolism.
- Angina.
- Chest or abdominal pain of any etiology.
- Oral or facial pain exacerbated by a mouthpiece.
- Stress incontinence.
- Dementia or state of confusion. 14, Acute Diarrhea
Trial locations and contacts
1 site in 1 country.
Poland1 site
National Institute for Tuberculosis and Lung Diseases
Warsaw, Masovian Voivodeship, 01-138
About this study
The investigators compared the ventilation parameters for volume and flow obtained from standard spirometry procedures from patients presently monitored and treated for asthma or chronic obstructive pulmonary disease (COPD) using AioCare (HealthUp Sp. z o.o., Serial Number: MS082017005412, software version: MySpiroo app 1.1.14) as the tested device and Spirometer USB CPFS/D (MGC Diagnostics) as the reference, which required calibration prior to each session. Spirometry measurements were performed on sixty-two patients (forty-four females (58±17 years old) and eighteen males (52±19 years old)) at the Institute of Tuberculosis and Lung Disease in Warsaw, Poland. Participants were asked to perform correct spirometry examinations (which means at least three technically correct exhales and meeting repeatability criteria for FEV1 and FVC) on both measuring devices with a five-minute break between devices to prevent respiratory muscle fatigue. The highest value from all acceptable spirometry results was then used for analysis. All spirometry examinations followed ERS/ATS standards.
- Being tested
- AioCare, Spirometer USB CPFS/D (MGC Diagnostics)
- Keywords
- Asthma, COPD, Mobile Spirometry
- 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.
AioCareDevice
AioCare is an ultraportable, handheld hardware module that contains the MEMS-based flow sensor and electronics, with a dedicated mobile application that works on iOS and Android operating systems. The unit is used with a disposable mouthpiece fitted to the tip of the flow tube, and a nose clip. AioCare is connected to its dedicated mobile application, which contains software that will show flow-volume graphs and results in real time. The device encompasses all of the widely used spirometry parameters, including: peak expiratory flow (PEF), forced expiratory volume in 1 second (FEV1), forced vital capacity (FVC), FEV1/FVC ratio, forced expiratory flow at 25% of expiration (FEF25), forced expiratory flow at 50% of expiration (FEF50), forced expiratory flow at 75% of expiration (FEF75), and forced expiratory volume in 6 second (FEV6).
Spirometer USB CPFS/D (MGC Diagnostics)Device
Spirometer USB CPFS/D (MGC Diagnostics) is a diagnostic desktop spirometer used in hospitals/clinics. CPFS/D USB spirometer is compatible with desktop and laptop computers.
| Study group | Role | What they receive |
|---|---|---|
| Sequence A | Active comparator | Patient would first perform an examination with handheld spirometer (AioCare), followed by measurements with the reference spirometer (MGC) Receives: Device: AioCare; Device: Spirometer USB CPFS/D (MGC Diagnostics) |
| Sequence B | Active comparator | Patient would first perform an examination with the reference spirometer (MGC), followed by measurements with handheld spirometer (AioCare) Receives: Device: AioCare; Device: Spirometer USB CPFS/D (MGC Diagnostics) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Non-inferiority of PEF between AioCare and CPFS/D USB Spirometer
Comparison of Peak Expiratory Flow obtained during a standard dynamic spirometry measured with AioCare (HealthUp) and reference spirometer (MGC)
Measured: 6 months
Non-inferiority of FEV1 between AioCare and CPFS/D USB Spirometer
Comparison of Forced Expiratory Volume in the first second (FEV1) obtained during a standard dynamic spirometry measured with AioCare (HealthUp) and reference spirometer (MGC)
Measured: 6 months
Non-inferiority of FVC between AioCare and CPFS/D USB Spirometer
Comparison of Forced Vital Capacity (FVC) obtained during a standard dynamic spirometry measured with AioCare (HealthUp) and reference spirometer (MGC)
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Mar 2019
- Study start18 Dec 2017
- Primary completion21 Jun 2018
- Study completion21 Jun 2018
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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 62 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Institute for Tuberculosis and Lung Diseases, Poland
- Sponsor type
- University, hospital or other
- Collaborators
- Healthup Sp. z o.o.
- Responsible party
- Principal investigator, Piotr Boros, National Institute for Tuberculosis and Lung Diseases, Poland
- Investigators
- Piotr Boros, Prof. dr hab. n. med., Principal investigator, National Institute for Tuberculosis and Lung Diseases, Poland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03894475
- Sponsor's protocol ID
- KB-6
- Status last verified
- Mar 2019
- First submitted
- 19 Mar 2019
- Last updated
- 28 Mar 2019
- 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 28 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Non-inferiority of Portable Versus Desktop Spirometry
- ClinicalTrials.gov ID
- NCT03894475
- Acronym / sponsor ID
- KB-6
- Keywords
- Asthma, COPD, Mobile Spirometry
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 62 participants (actual)
- Lead sponsor
- National Institute for Tuberculosis and Lung Diseases, PolandUniversity, hospital or other
- Collaborators
- Healthup Sp. z o.o.
- Study start
- 18 Dec 2017 (actual)
- Primary completion
- 21 Jun 2018 (actual)
- Study completion
- 21 Jun 2018 (actual)
- First posted
- 28 Mar 2019 (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.
The investigators compared the ventilation parameters for volume and flow obtained from standard spirometry procedures from patients presently monitored and treated for asthma or chronic obstructive pulmonary disease (COPD) using AioCare (HealthUp Sp. z o.o., Serial Number: MS082017005412, software version: MySpiroo app 1.1.14) as the tested device and Spirometer USB CPFS/D (MGC Diagnostics) as the reference, which required calibration prior to each session. Spirometry measurements were performed on sixty-two patients (forty-four females (58±17 years old) and eighteen males (52±19 years old)) at the Institute of Tuberculosis and Lung Disease in Warsaw, Poland. Participants were asked to perform correct spirometry examinations (which means at least three technically correct exhales and meeting repeatability criteria for FEV1 and FVC) on both measuring devices with a five-minute break between devices to prevent respiratory muscle fatigue. The highest value from all acceptable spirometry results was then used for analysis. All spirometry examinations followed ERS/ATS standards.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sequence A | Active comparator | Device: AioCare, Device: Spirometer USB CPFS/D (MGC Diagnostics)Patient would first perform an examination with handheld spirometer (AioCare), followed by measurements with the reference spirometer (MGC) |
| Sequence B | Active comparator | Device: AioCare, Device: Spirometer USB CPFS/D (MGC Diagnostics)Patient would first perform an examination with the reference spirometer (MGC), followed by measurements with handheld spirometer (AioCare) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age>18.
- Diagnosed asthma or COPD
- Signed consent to participation in the research experiment.
- Ability to comply with the spirometry protocol.
Key exclusion criteria (13 listed)
- Pregnant females (based on declaration; no pregnancy tests are planned before the test).
- Recent myocardial infarction (<30 days).
- Known thoracic, aortic or cerebral aneurysm.
- Recent stroke, eye surgery, thoracic/abdominal surgery.
- Haemoptysis.
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 |
|---|---|---|
| AioCareAioCare is an ultraportable, handheld hardware module that contains the MEMS-based flow sensor and electronics, with a dedicated mobile application that works on iOS and Android operating systems. The unit is used with a disposable mouthpiece fitted to the tip of the flow tube, and a nose clip. AioCare is connected to its dedicated mobile application, which contains software that will show flow-volume graphs and results in real time. The device encompasses all of the widely used spirometry parameters, including: peak expiratory flow (PEF), forced expiratory volume in 1 second (FEV1), forced vital capacity (FVC), FEV1/FVC ratio, forced expiratory flow at 25% of expiration (FEF25), forced expiratory flow at 50% of expiration (FEF50), forced expiratory flow at 75% of expiration (FEF75), and forced expiratory volume in 6 second (FEV6). | Device | Sequence A, Sequence B |
| Spirometer USB CPFS/D (MGC Diagnostics)Spirometer USB CPFS/D (MGC Diagnostics) is a diagnostic desktop spirometer used in hospitals/clinics. CPFS/D USB spirometer is compatible with desktop and laptop computers. | Device | Sequence A, Sequence B |
Primary outcome
Non-inferiority of PEF between AioCare and CPFS/D USB Spirometer
Time frame: 6 months
Comparison of Peak Expiratory Flow obtained during a standard dynamic spirometry measured with AioCare (HealthUp) and reference spirometer (MGC)
Non-inferiority of FEV1 between AioCare and CPFS/D USB Spirometer
Time frame: 6 months
Comparison of Forced Expiratory Volume in the first second (FEV1) obtained during a standard dynamic spirometry measured with AioCare (HealthUp) and reference spirometer (MGC)
Non-inferiority of FVC between AioCare and CPFS/D USB Spirometer
Time frame: 6 months
Comparison of Forced Vital Capacity (FVC) obtained during a standard dynamic spirometry measured with AioCare (HealthUp) and reference spirometer (MGC)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Mar 2019.
- Individual participant dataSharing planned: Undecided
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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.
Piotr Boros, Prof. dr hab. n. med. principal investigator
National Institute for Tuberculosis and Lung Diseases, Poland
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing AioCare and Spirometer USB CPFS/D (MGC Diagnostics) in people with Asthma and COPD, run by National Institute for Tuberculosis and Lung Diseases, Poland at 1 site in Poland.
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 4 inclusion and 13 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: finished, as of the sponsor's last update on 28 Mar 2019. 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 Poland. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Non-inferiority of PEF between AioCare and CPFS/D USB Spirometer (time frame: 6 months). The study lists 3 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 28 Mar 2019.