Clinical trial NCT05655832: 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
Official title: 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 Chronic Obstructive Pulmonary Disease (COPD)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pulmonary Disease, Chronic Obstructive
Lead sponsor: Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany
Sponsor class: INDUSTRY
First posted: 2022-12-19
Enrollment: 77
Sex: ALL
Minimum age (years): 40
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

For participants with COPD:

* Participants ≥40 and ≤80 years at baseline
* Diagnosis of COPD stage II to IV
* History 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 baseline

Exclusion 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 study
* Participants with a cardiac pacemaker, defibrillators, or other implanted electronic devices
* Participants with known allergies or sensitivity to silicon or hydrogel
* Less than 6 weeks since previous moderate/severe exacerbation

For participants in the calibration cohort:

* Participants with a cardiac pacemaker, defibrillators, or other implanted electronic devices
* Participants with known allergies or sensitivity to silicon or hydrogel
* Diagnosis of pulmonary disease including, but not limited to COPD, asthma, pulmonary fibrosis, with impact on the lung function and exercise capacity

Primary outcomes:
measure: Occurrence of COPD exacerbations
timeFrame: 3 months
measure: Severity of exacerbations
timeFrame: 3 months
Secondary outcomes:
measure: COPD Assessment Test (CAT) Questionnaire: Patients' health status and symptoms at baseline and study end
timeFrame: Baseline (Day 0) and at 3 months
measure: Lung function measuring Forced Expiratory Volume in 1 second (FEV1) as assessed using body plethysmography
timeFrame: Baseline (Day 0) and at 3 months
measure: Lung function measuring FEV1 / Forced Vital Capacity (FVC) as assessed using body plethysmography
timeFrame: Baseline (Day 0) and at 3 months
measure: Number of COPD exacerbations
timeFrame: 3 months
Other outcomes:
Locations:
city: Berlin
country: Germany
facility: Praxis an der Oper
city: Darmstadt
country: Germany
facility: Lungenzentrum Darmstadt GmbH
city: Darmstadt
country: Germany
facility: Städtische Kliniken Darmstadt
city: Frankfurt
country: Germany
facility: Lungenzentrum Frankfurt
city: Heidelberg
country: Germany
facility: Thoraxklinik Heidelberg gGmbH
city: Mannheim
country: Germany
facility: ZERO Praxen
city: München
country: Germany
facility: Pneumologisches Studienzentrum München-West
city: Saarbrücken
country: Germany
facility: Pneumologische Gemeinschaftspraxis Saarbrücken
city: Schleswig
country: Germany
facility: RespiRatio / Lungenpraxis
city: Wiesbaden
country: Germany
facility: Pneumologische Praxis Wiesbaden
city: Witten
country: Germany
facility: Lungenpraxis Dr. Franz / Dr. Weber
Study officials:
affiliation: Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany
name: Medical Responsible
role: STUDY_DIRECTOR
References: