COPD Symptoms After Coil Procedure
Conditions
Keywords
COPD, Coils, App
Brief summary
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.
Detailed description
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.
Interventions
BEHAVIORALCOPD Co-Pilot AIR App
App. For COPD symptoms after Coil procedure
Sponsors
PneumRx, Inc.
Boston Scientific Corporation
Study design
Observational model
CASE_ONLY
Time perspective
OTHER
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Participant has read, understood, and signed a CLN0020 informed consent form prior to enrollment. 2. Participant is appropriate for Coil treatment per the Conformité Européene (European Conformity \[CE\])-Mark Approved RePneu Instructions for Use (IFU). 3. Participant has been enrolled in and scheduled for treatment(s) with the PneumRx Endobronchial Coil procedure in the CLN0014 study. 4. Participant's PneumRx Endobronchial Coil procedure is scheduled to occur no fewer than 14 days from enrollment, providing enough time to establish a baseline of their daily symptoms. Ten days minimum of baseline data are required, which is defined as the Run-in period going forward. 5. Participant is willing and able to use a smart phone.
Exclusion criteria
1. Participant has undergone a Coil procedure. 2. Participant has had an acute exacerbation of COPD that required hospitalization or emergency room visit or treatment with systemic steroids and/or antibiotics during the 28 days prior to CLN0020 enrollment. 3. Participant has a COPD exacerbation or respiratory illness during the Run-in period that in the judgment of the investigator requires medical intervention (for example, treatment with systemic steroids and/or antibiotics and/or hospitalization). 4. Participant is suffering from terminal illness expected to adversely affect survival in the next 12 months. 5. Participant has a history of non-compliance with medical therapies.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Rate of COPD Exacerbation | 12 months | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Respiratory Related SAEs | 12 months | 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. |
| Rate of First Respiratory-Related SAEs | 12 months | 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 to First Respiratory-Related SAE | 12 months | 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. |
Countries
Switzerland
Outcome results
None listed