Chronic Obstructive Pulmonary Disease (COPD) Co-Pilot AIR Substudy of CLN0014 (Co-Pilot Air)

Observational Study of HGE Health Care Solution COPD Co-Pilot AIR™ Application in Subjects Undergoing the PneumRx® Endobronchial Coil Procedure as Part of EU Registry CLN0014

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.

Study Overview

• Status: Terminated
• Conditions: COPD Symptoms After Coil Procedure
• Intervention / Treatment: Behavioral: COPD Co-Pilot AIR App

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.

• Study Type: Observational
• Enrollment (Actual): 9

Contacts and Locations

Study Locations

• Switzerland
  • Genève, Switzerland, 1211
    • Hôpitaux Universitaires de Genève (HUG) Service
  • Zürich, Switzerland, 8091
    • UniversitätsSpital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Participants with COPD undergoing the PneumRx Endobronchial Coil Treatment in a post-market setting.

Description

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.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	12 months

Collaborators and Investigators

• Sponsor: Boston Scientific Corporation
• Collaborators: PneumRx, Inc.
• Investigators: Principal Investigator: Daniel Franzen, MD, Klinik für Pneumologie, Zurich

Study record dates

Study Major Dates

• Study Start (Actual): February 10, 2017
• Primary Completion (Actual): October 20, 2018
• Study Completion (Actual): October 20, 2018

Study Registration Dates

• First Submitted: August 29, 2017
• First Submitted That Met QC Criteria: August 29, 2017
• First Posted (Actual): August 31, 2017

Study Record Updates

• Last Update Posted (Actual): July 16, 2021
• Last Update Submitted That Met QC Criteria: July 15, 2021
• Last Verified: July 1, 2021

More Information

Terms related to this study

• Keywords: COPD; App; Coils
• Other Study ID Numbers: CLN0020

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No