The purpose of undertaking CLN0020, which was a Substudy of the European Coil registry (CLN0014), was to investigate the use of COPD Co-Pilot AIR™, a COPD disease management program manufactured and operated by HGE Health Care Solutions, LLC, in participants undergoing the PneumRx Endobronchial Coil Treatment in a post-market setting.
COPD Co-Pilot AIR™ combines a digital respiratory symptom reporting participant application (an "app") with facilitation of rapid personalized clinical recommendations made by the participant's health care provider and communicated to the participant through the application. COPD Co-Pilot AIR™ provides early identification of an increase in a participant's respiratory symptoms relative to the participant's own baseline symptom profile which in turn enables health care providers to rapidly implement modified treatment plans.
Study Type
OBSERVATIONAL
Enrollment
9
App. For COPD symptoms after Coil procedure
Hôpitaux Universitaires de Genève (HUG) Service
Geneva, Switzerland
UniversitätsSpital
Zurich, Switzerland
Rate of COPD Exacerbation
Rate of COPD Exacerbation serious adverse events (SAEs) reported in the 12-month period following the initial Endobronchial Coil procedure for participants enrolled in CLN0020 when compared to CLN0014 participant population that was not managed utilizing COPD Co-Pilot AIR.
Time frame: 12 months
Respiratory Related SAEs
Percent of participants experiencing one or more respiratory-related SAEs in the 12-month period following the initial Coil procedure comparing participants enrolled in CLN0020 to non-COPD Co-Pilot AIR participants in CLN0014.
Time frame: 12 months
Rate of First Respiratory-Related SAEs
Rate of first respiratory-related SAEs reported in the 12-month period following the initial Coil procedure comparing participants enrolled in CLN0020 to non-COPD Co-Pilot AIR participants enrolled in CLN0014.
Time frame: 12 months
Time to First Respiratory-Related SAE
Time to first respiratory-related SAE following the initial Coil procedure comparing participants enrolled in CLN0020 to non-COPD Co-Pilot AIR participants enrolled in CLN0014.
Time frame: 12 months
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