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

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ClinicalTrials.gov Identifier: NCT03267992
Recruitment Status : Terminated (Study enrollment was prematurely stopped for business reasons.)
First Posted : August 31, 2017
Last Update Posted : May 9, 2019
Sponsor:
Information provided by (Responsible Party):
PneumRx, Inc.

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.

Condition or disease Intervention/treatment
COPD Symptoms After Coil Procedure Behavioral: COPD Co-Pilot AIR App

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.

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Study Type : Observational [Patient Registry]
Actual Enrollment : 9 participants
Observational Model: Case-Only
Time Perspective: Other
Target Follow-Up Duration: 1 Year
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
Actual Study Start Date : February 10, 2017
Actual Primary Completion Date : October 20, 2018
Actual Study Completion Date : October 20, 2018

Intervention Details:
  • Behavioral: COPD Co-Pilot AIR App
    App. For COPD symptoms after Coil procedure


Primary Outcome Measures :
  1. Rate of COPD Exacerbation [ Time Frame: 12 months ]
    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.


Secondary Outcome Measures :
  1. Respiratory Related SAEs [ Time Frame: 12 months ]
    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.

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

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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   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.
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03267992


Locations
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Switzerland
Hôpitaux Universitaires de Genève (HUG) Service
Genève, Switzerland, 1211
UniversitätsSpital
Zürich, Switzerland, 8091
Sponsors and Collaborators
PneumRx, Inc.
Investigators
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Principal Investigator: Daniel Franzen, MD Klinik für Pneumologie, Zurich

Additional Information:

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Responsible Party: PneumRx, Inc.
ClinicalTrials.gov Identifier: NCT03267992     History of Changes
Other Study ID Numbers: CLN0020
First Posted: August 31, 2017    Key Record Dates
Last Update Posted: May 9, 2019
Last Verified: May 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by PneumRx, Inc.:
COPD
Coils
App

Additional relevant MeSH terms:
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Pulmonary Disease, Chronic Obstructive
Lung Diseases, Obstructive
Lung Diseases
Respiratory Tract Diseases