COPD Symptoms After Coil ProcedureCo-Pilot AirNCT03267992
Chronic Obstructive Pulmonary Disease (COPD) Co-Pilot AIR Substudy of CLN0014
An observational study of COPD Symptoms After Coil Procedure, run by Boston Scientific Corporation at 2 sites in Switzerland.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- COPD Symptoms After Coil Procedure
- What is being tested?
- COPD Co-Pilot AIR App
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 9 participants
- Where
- 2 sitesSwitzerland
- Study dates
- 10 Feb 2017to 20 Oct 2018
- How long will I take part?
- 1 Year
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Participants with COPD undergoing the PneumRx Endobronchial Coil Treatment in a post-market setting.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country.
Switzerland2 sites
Hôpitaux Universitaires de Genève (HUG) Service
Geneva, 1211
UniversitätsSpital
Zurich, 8091
About this study
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
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
- COPD Symptoms After Coil Procedure
- Being tested
- COPD Co-Pilot AIR App
- Keywords
- COPD, Coils, App
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive, Alzheimer Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
COPD Co-Pilot AIR AppBehavioural
App. For COPD symptoms after Coil procedure
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12 months
Secondary outcomes (3)
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.
Measured: 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.
Measured: 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.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2017
- Study start10 Feb 2017
- Primary completion20 Oct 2018
- Study completion20 Oct 2018
Why it stopped: Study enrollment was prematurely stopped for business reasons.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COPD Symptoms After Coil ProcedureStudies of the same condition, open and under way.
- More trials run by Boston Scientific CorporationThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Other
- Enrolment
- 9 participants (actual)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- Boston Scientific Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- PneumRx, Inc.
- Responsible party
- Sponsor
- Investigators
- Daniel Franzen, MD, Principal investigator, Klinik für Pneumologie, Zurich
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03267992
- Sponsor's protocol ID
- CLN0020
- Acronym
- Co-Pilot Air
- Status last verified
- Jul 2021
- First submitted
- 29 Aug 2017
- Last updated
- 16 Jul 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03267992
- Acronym / sponsor ID
- Co-Pilot Air / CLN0020
- Conditions
- COPD Symptoms After Coil Procedure
- Keywords
- COPD, Coils, App
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Study enrollment was prematurely stopped for business reasons.
- Enrolment
- 9 participants (actual)
- Lead sponsor
- Boston Scientific CorporationIndustry (pharma, biotech, devices)
- Collaborators
- PneumRx, Inc.
- Study start
- 10 Feb 2017 (actual)
- Primary completion
- 20 Oct 2018 (actual)
- Study completion
- 20 Oct 2018 (actual)
- First posted
- 31 Aug 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Other
- Target follow-up
- 1 Year
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Participants with COPD undergoing the PneumRx Endobronchial Coil Treatment in a post-market setting.
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| COPD Co-Pilot AIR AppApp. For COPD symptoms after Coil procedure | Behavioural | – |
Primary outcome
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.
3 secondary outcomes
Respiratory Related SAEs
Time frame: 12 months
Rate of First Respiratory-Related SAEs
Time frame: 12 months
Time to First Respiratory-Related SAE
Time frame: 12 months
Results and safety
The study was stopped early (reason given: Study enrollment was prematurely stopped for business reasons.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jul 2021.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Daniel Franzen, MD principal investigator
Klinik für Pneumologie, Zurich
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of COPD Symptoms After Coil Procedure, run by Boston Scientific Corporation at 2 sites in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 16 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Study enrollment was prematurely stopped for business reasons.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of COPD Exacerbation (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jul 2021.