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

NCT03267992 | Terminated

• 1 other identifier: CLN0020
• Study Type: observational
• Target: 9
• Locations: 1 country
• Sites: 2

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.

Conditions

COPD Symptoms After Coil Procedure

Keywords

COPD; Coils; App

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Respiratory Related SAEs

  12 months

• Rate of First Respiratory-Related SAEs

  12 months

• Time to First Respiratory-Related SAE

  12 months

Interventions

COPD Co-Pilot AIR App BEHAVIORAL

App. For COPD symptoms after Coil procedure

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

• Participant has read, understood, and signed a CLN0020 informed consent form prior to enrollment.
• Participant is appropriate for Coil treatment per the Conformité Européene (European Conformity \[CE\])-Mark Approved RePneu Instructions for Use (IFU).
• Participant has been enrolled in and scheduled for treatment(s) with the PneumRx Endobronchial Coil procedure in the CLN0014 study.
• 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.
• Participant is willing and able to use a smart phone.

You may not qualify if:

• Participant has undergone a Coil procedure.
• 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.
• 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).
• Participant is suffering from terminal illness expected to adversely affect survival in the next 12 months.
• Participant has a history of non-compliance with medical therapies.

Sponsors & Collaborators

• Boston Scientific Corporation: lead
• PneumRx, Inc.: collaborator

Study Sites (2)

Hôpitaux Universitaires de Genève (HUG) Service

Geneva, 1211, Switzerland

Location

UniversitätsSpital

Zurich, 8091, Switzerland

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive; Alzheimer Disease

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders

Study Officials

• Daniel Franzen, MD

  Klinik für Pneumologie, Zurich

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: OTHER
• Target Duration: 1 Year
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 29, 2017
• First Posted: August 31, 2017
• Study Start: February 10, 2017
• Primary Completion: October 20, 2018
• Study Completion: October 20, 2018
• Last Updated: July 16, 2021

Record last verified: 2021-07

Locations

CH (2)