A Study to Investigate the Association of Real-world Sensor-derived Biometric Data With Clinical Parameters and Patient-reported Outcomes for Monitoring Disease Activity in Patients With COPD

The purpose of this multicenter, prospective cohort study is to investigate the correlation of real-world sensor-derived biometric data obtained via a wearable device with clinical parameters and patient-reported outcomes (PROs) for monitoring disease activity and predicting exacerbations for participants with Chronic Obstructive Pulmonary Disease (COPD). The cohort of participants with COPD will be followed for 3 months. A calibration cohort with non-COPD participants will be included and followed for 2 weeks.

Inclusion Criteria:For participants with COPD:Participants ≥40 and ≤80 years at baselineDiagnosis of COPD stage II to IVHistory of moderate or severe exacerbations (≥2 moderate exacerbations or ≥1 severe exacerbations in any 12-month time window during last 3 years prior to inclusion and ≥1 moderate or severe exacerbations in the last 12 months prior to inclusion, considering that the last 12 months may reflect lower exacerbation rate due to Covid-19 measures)For participants in the calibration cohort:• Participants ≥40 and ≤80 years at baselineExclusion Criteria:For participants with COPD:Clinically relevant and/or serious concurrent medical conditions including, but not limited to visual problems, severe mental illness or cognitive impairment, musculoskeletal or movement disorders, cardiac disease (e.g., heart failure, arrythmia [esp. atrial fibrillation and conduction blocks]), lung cancer (currently treated) that in the opinion of the Investigator, would interfere with participant's ability to participate in the study or draw meaningful conclusions from the studyParticipants with a cardiac pacemaker, defibrillators, or other implanted electronic devicesParticipants with known allergies or sensitivity to silicon or hydrogelLess than 6 weeks since previous moderate/severe exacerbationFor participants in the calibration cohort:Participants with a cardiac pacemaker, defibrillators, or other implanted electronic devicesParticipants with known allergies or sensitivity to silicon or hydrogelDiagnosis of pulmonary disease including, but not limited to COPD, asthma, pulmonary fibrosis, with impact on the lung function and exercise capacity