Ignite Creation Date:
2025-12-24 @ 9:58 PM
Ignite Modification Date:
2026-02-27 @ 4:06 PM
Study NCT ID:
NCT05655832
Status:
COMPLETED
Last Update Posted:
2023-11-13
First Post:
2022-11-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief 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 COPD
Sponsor:
Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany
Organization:
Study Overview
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)
Status:
COMPLETED
Status Verified Date:
2023-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: