NCT03894475

Non-inferiority of Portable Versus Desktop Spirometry

National Institute for Tuberculosis and Lung Diseases, Poland·ClinicalTrials.gov·device·Device trialCompleted
View on ClinicalTrials.gov
Study focus
Disease/Condition
Asthma,COPD
Drug/Device/Intervention
AioCare
Study type
Interventional
Intervention type
device
Sponsor & location
Primary sponsor
National Institute for Tuberculosis and Lung Diseases, Poland
Location
Warsaw, Poland
Timeline & enrollment
Phase
N/A
Start date
Dec 18, 2017
End date
Jun 21, 2018
Enrollment
62 participants
Primary outcome

Non-inferiority of PEF between AioCare and CPFS/D USB Spirometer,Non-inferiority of FEV1 between AioCare and CPFS/D USB Spirometer,Non-inferiority of FVC between AioCare and CPFS/D USB Spirometer

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. 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.

ICD-10 classifications
AsthmaAsthma, unspecifiedNonallergic asthmaMixed asthmaOther chronic obstructive pulmonary disease
Data source
Registry
ClinicalTrials.gov
Trial ID
NCT03894475
Type
Device Trial
About this record

Access comprehensive clinical trial information for NCT03894475 through Pure Global AI's free database. This phase not specified trial is sponsored by National Institute for Tuberculosis and Lung Diseases, Poland and is currently Completed. The study focuses on Asthma,COPD. Target enrollment is 62 participants.

This page provides complete trial specifications, intervention details, outcomes, and location information. Pure Global AI offers free access to ClinicalTrials.gov data, helping medical device and pharmaceutical companies navigate clinical research efficiently.