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

NCT ID: NCT03267992

Last Updated: 2021-07-16

Basic Information

• Recruitment Status: TERMINATED
• Total Enrollment: 9 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2017-02-10
• Study Completion Date: 2018-10-20

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.

Conditions

COPD Symptoms After Coil Procedure

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: OTHER

Interventions

COPD Co-Pilot AIR App

App. For COPD symptoms after Coil procedure

Intervention Type: BEHAVIORAL

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

PneumRx, Inc.

INDUSTRY

Sponsor Role: collaborator

Boston Scientific Corporation

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Daniel Franzen, MD

Role: PRINCIPAL_INVESTIGATOR

Klinik für Pneumologie, Zurich

Locations

Hôpitaux Universitaires de Genève (HUG) Service

Geneva, , Switzerland

UniversitätsSpital

Zurich, , Switzerland

Countries

Switzerland

Other Identifiers

CLN0020

Identifier Type: -

Identifier Source: org_study_id