COPDeCOPDNCT02258191
Pilot Study Evaluating Feasibility and Benefits of Telemonitored NIV Treatment on COPD Patients
A study testing telemonitoring in people with COPD, run by ResMed at 1 site in France.
Trial summary
Pilot study evaluating feasibility and benefits of telemonitored NIV (noninvasive ventilation) treatment on COPD (chronic obstructive pulmonary disease) patients. Multicentric Randomized Controlled Trial Primary Objective: To evaluate benefits of telemonitoring system, Easy Care Online (ECO), on NIV long term… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- COPD
- What is being tested?
- telemonitoring
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteFrance
- Study dates
- Jul 2014to Jan 2018
- Phase
- Interventional
- 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
Who may be able to join
- COPD patient already treated by NIV requiring therapy assessment in their routine care Follow-Up or
- COPD patient requiring de Novo NIV therapy according to routine care rules (NIV<12h)
- Patient requiring NIV therapy by S9 VPAP ST +/- oxygen therapy
- Patient willing to participate to the study
- Patient or attendant able to complete patient passport and to come to Follow-Up visits.
Who cannot join
- NIV therapy Failure during screening phase (intolerance, patient refusal, significant leaks, significant AHI or Oxymetry events)
- Hospitalization conducting to NIV discontinuation for at least 1 week during the screening phase
Trial locations and contacts
1 site in 1 country.
About this study
Pilot study evaluating feasibility and benefits of telemonitored NIV (noninvasive ventilation) treatment on COPD (chronic obstructive pulmonary disease) patients.
Multicentric Randomized Controlled Trial
Primary Objective:
To evaluate benefits of telemonitoring system, Easy Care Online (ECO), on NIV long term treatment efficacy and patient compliance
Secondary Objectives:
To determine predictive factors of COPD exacerbation in patients treated by NIV with ECO To carry out a health economic evaluation on telemonitoring benefits in COPD pts treated with NIV
- Conditions
- COPD
- Being tested
- telemonitoring, sham telemonitoring
- Keywords
- NIV, COPD, telemonitoring
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
telemonitoringDevice
Also called Easy Care online
sham telemonitoringDevice
Also called Easy Care online
| Study group | Role | What they receive |
|---|---|---|
| NIV treatment with telemonitoring | Active comparator | telemonitoring is used to manage NIV treatment Receives: Device: telemonitoring |
| NIV treatment with sham telemonitoring | Sham comparator | sham telemonitoring (data not used for NIV management) Receives: Device: sham telemonitoring |
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood Gaz and nocturnal transcutaneous carbon dioxyde partial pressure (PtCO2) evolution
Measured: 12 months
Compliance evolution: mean duration usage (hour per day)
Measured: 12 months
Secondary outcomes (14)
Non-Intentional leaks
Measured: 12 months
Peripheral oxygen saturation (SP02)
Measured: 12 months
Apnea Hypopnea Index (AHI)
Measured: 12 months
Oxygen desaturation Index (ODI)
Measured: 12 months
Time with peripheral oxygen saturation (SP02) < 90%
Measured: 12 months
St Georges Quality of Life questionnaire
Measured: 12 months
6 Minutes Walking Test (6MWT)
Measured: 12 months
The Body-Mass Index, Airflow Obstruction, Dyspnea, and Exercise Capacity - (BODE) Index
Measured: 12 months
Epworth Sleepiness Scale (ESS)
Measured: 12 months
% of patients with Ventilatory asynchronisms
Measured: 12 months
Mean Noninvasive Ventilation (NIV) use duration (hour/day)
Measured: 12 months
% of days with noninvasive Ventilation (NIV) use ≥ 4h/day
Measured: 12 months
% of days with noninvasive Ventilation (NIV) use < 4h/day
Measured: 12 months
% of days with no Noninvasive Ventilation (NIV) use
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 posted7 Oct 2014 (estimated)
- Study startJul 2014
- Primary completionJan 2018
- Study completionJan 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COPDStudies of the same condition, open and under way.
- More trials run by ResMedThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- ResMed
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Thibaut Gentina, MD, Principal investigator, Hôpital Privé la Louvière - Lille
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02258191
- Sponsor's protocol ID
- eCOPD 001
- Acronym
- eCOPD
- Status last verified
- Jan 2018
- First submitted
- 24 Sep 2014
- Last updated
- 23 Jan 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study Evaluating Feasibility and Benefits of Telemonitored NIV Treatment on COPD Patients
- ClinicalTrials.gov ID
- NCT02258191
- Acronym / sponsor ID
- eCOPD / eCOPD 001
- Conditions
- COPD
- Keywords
- NIV, COPD, telemonitoring
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- ResMedIndustry (pharma, biotech, devices)
- Study start
- Jul 2014
- Primary completion
- Jan 2018 (actual)
- Study completion
- Jan 2018 (actual)
- First posted
- 7 Oct 2014 (estimated)
- 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.
Pilot study evaluating feasibility and benefits of telemonitored NIV (noninvasive ventilation) treatment on COPD (chronic obstructive pulmonary disease) patients.
Multicentric Randomized Controlled Trial
Primary Objective:
To evaluate benefits of telemonitoring system, Easy Care Online (ECO), on NIV long term treatment efficacy and patient compliance
Secondary Objectives:
To determine predictive factors of COPD exacerbation in patients treated by NIV with ECO To carry out a health economic evaluation on telemonitoring benefits in COPD pts treated with NIV
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| NIV treatment with telemonitoring | Active comparator | Device: telemonitoringtelemonitoring is used to manage NIV treatment |
| NIV treatment with sham telemonitoring | Sham comparator | Device: sham telemonitoringsham telemonitoring (data not used for NIV management) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- COPD patient already treated by NIV requiring therapy assessment in their routine care Follow-Up or
- COPD patient requiring de Novo NIV therapy according to routine care rules (NIV<12h)
- Patient requiring NIV therapy by S9 VPAP ST +/- oxygen therapy
- Patient willing to participate to the study
- Patient or attendant able to complete patient passport and to come to Follow-Up visits.
Key exclusion criteria (2 listed)
- NIV therapy Failure during screening phase (intolerance, patient refusal, significant leaks, significant AHI or Oxymetry events)
- Hospitalization conducting to NIV discontinuation for at least 1 week during the screening phase
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 |
|---|---|---|
| telemonitoringAlso: Easy Care online | Device | NIV treatment with telemonitoring |
| sham telemonitoringAlso: Easy Care online | Device | NIV treatment with sham telemonitoring |
Primary outcome
Blood Gaz and nocturnal transcutaneous carbon dioxyde partial pressure (PtCO2) evolution
Time frame: 12 months
Compliance evolution: mean duration usage (hour per day)
Time frame: 12 months
14 secondary outcomes
Non-Intentional leaks
Time frame: 12 months
Peripheral oxygen saturation (SP02)
Time frame: 12 months
Apnea Hypopnea Index (AHI)
Time frame: 12 months
Oxygen desaturation Index (ODI)
Time frame: 12 months
Time with peripheral oxygen saturation (SP02) < 90%
Time frame: 12 months
St Georges Quality of Life questionnaire
Time frame: 12 months
6 Minutes Walking Test (6MWT)
Time frame: 12 months
The Body-Mass Index, Airflow Obstruction, Dyspnea, and Exercise Capacity - (BODE) Index
Time frame: 12 months
Epworth Sleepiness Scale (ESS)
Time frame: 12 months
% of patients with Ventilatory asynchronisms
Time frame: 12 months
Mean Noninvasive Ventilation (NIV) use duration (hour/day)
Time frame: 12 months
% of days with noninvasive Ventilation (NIV) use ≥ 4h/day
Time frame: 12 months
% of days with noninvasive Ventilation (NIV) use < 4h/day
Time frame: 12 months
% of days with no Noninvasive Ventilation (NIV) use
Time frame: 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jan 2018.
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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.
Thibaut Gentina, MD principal investigator
Hôpital Privé la Louvière - Lille
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing telemonitoring in people with COPD, run by ResMed at 1 site in France.
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 2 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: finished, as of the sponsor's last update on 23 Jan 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. 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. Some participants in this study may receive a placebo. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Blood Gaz and nocturnal transcutaneous carbon dioxyde partial pressure (PtCO2) evolution (time frame: 12 months). The study lists 2 primary outcomes in all. 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 23 Jan 2018.