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

• Register: ClinicalTrials.gov
• Last refreshed on: 26 July 2021
• Main ID: NCT03267992
• Date of registration: 29/08/2017
• Prospective Registration: No
• Primary sponsor: Boston Scientific Corporation
• Public title: Chronic Obstructive Pulmonary Disease (COPD) Co-Pilot AIR Substudy of CLN0014 Co-Pilot Air
• Scientific 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
• Date of first enrolment: February 10, 2017
• Target sample size: 9
• Recruitment status: Terminated
• URL: https://clinicaltrials.gov/show/NCT03267992
• Study type: Observational [Patient Registry]

Countries of recruitment

Switzerland

Contacts

• Name: Daniel Franzen, MD
• Affiliation: Klinik für Pneumologie, Zurich

Key inclusion & exclusion 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.



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

COPD Symptoms After Coil Procedure

Intervention(s)

Behavioral: COPD Co-Pilot AIR App

Primary Outcome(s)

Rate of COPD Exacerbation [Time Frame: 12 months]

Secondary Outcome(s)

Rate of First Respiratory-Related SAEs [Time Frame: 12 months]

Respiratory Related SAEs [Time Frame: 12 months]

Time to First Respiratory-Related SAE [Time Frame: 12 months]

Secondary ID(s)

CLN0020

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

PneumRx, Inc.