Clinical trial NCT03267992: Chronic Obstructive Pulmonary Disease (COPD) Co-Pilot AIR Substudy of CLN0014
Official title: 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
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: COPD Symptoms After Coil Procedure
Keywords: COPD
Coils
App
Lead sponsor: Boston Scientific Corporation
Sponsor class: INDUSTRY
Collaborators: name: PneumRx, Inc.
First posted: 2017-08-31
Enrollment: 9
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: OTHER
Sampling method: PROBABILITY_SAMPLE
Study population: Participants with COPD undergoing the PneumRx Endobronchial Coil Treatment in a post-market setting.

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.

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.

Primary outcomes:
measure: Rate of COPD Exacerbation
timeFrame: 12 months
Secondary outcomes:
measure: Respiratory Related SAEs
timeFrame: 12 months
measure: Rate of First Respiratory-Related SAEs
timeFrame: 12 months
measure: Time to First Respiratory-Related SAE
timeFrame: 12 months
Other outcomes:
Locations:
city: Genève
country: Switzerland
facility: Hôpitaux Universitaires de Genève (HUG) Service
city: Zürich
country: Switzerland
facility: UniversitätsSpital
Study officials:
affiliation: Klinik für Pneumologie, Zurich
name: Daniel Franzen, MD
role: PRINCIPAL_INVESTIGATOR
References: