TerminatedNCT03267992Co-Pilot AirUpdated Jul 16, 2021

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

An observational study in COPD Symptoms After Coil Procedure, sponsored by Boston Scientific Corporation. Terminated at 2 sites in Switzerland. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-07-16.

Sponsored by Boston Scientific Corporation · Observational

Why this study was terminated

Study enrollment was prematurely stopped for business reasons.

Study type: Observational
Model: Case-only
Time perspective: Other
Enrollment: 9
Ages: 18 Years and older
Sex: All

Study 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.

Read the 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 studied

COPD Symptoms After Coil Procedure

Keywords

COPD
Coils
App

Who can participate

Ages eligible: 18 Years and older
Sexes eligible: All
Accepts healthy volunteers: No
Sampling method: Probability sample

Study population

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

Inclusion criteria

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.

Exclusion criteria

Exclusion Criteria:

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.

Study design

Observational model: Case-only
Time perspective: Other
Enrollment: 9 participants (actual)
Target follow-up: 1 Year
Patient registry: Yes

Interventions

BehavioralCOPD Co-Pilot AIR App
App. For COPD symptoms after Coil procedure

What researchers measure

Primary outcomes

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

Secondary outcomes

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

Study locations

2 sites

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

Registry details

Key details

Study ID: NCT03267992
Lead sponsor: Boston Scientific Corporation
Collaborators: PneumRx, Inc.
Responsible party: Sponsor
First posted: Aug 31, 2017
Start date: Feb 10, 2017
Primary completion: Oct 20, 2018
Completion: Oct 20, 2018
Last update: Jul 16, 2021

Study contacts

Daniel Franzen, MD

principal investigator · Klinik für Pneumologie, Zurich

Oversight

Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No

View the source record on ClinicalTrials.gov ↗

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This study is terminated, as verified in Jul 2021. You cannot join it, but the record below documents what was studied.

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