COPDNCT05109754
Home Non-Invasive Ventilation Targeting Expiratory Flow Limitation in Severe Hypercapnic COPD.
A study testing BiPAP EFL in people with COPD, run by McGill University Health Centre/Research Institute of the McGill University Health Centre at 1 site in Canada.
Trial summary
In this 2-phase pilot study, the BiPAP A40 EFL will be evaluated in patients with severe COPD requiring home non-invasive ventilatory support with respect to patient-related and physiologic outcomes. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- COPD
- What is being tested?
- BiPAP EFL
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteCanada
- Study dates
- Oct 2025to Dec 2027
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Phase 1:
- severe COPD with FEV1<50%, using home NIV successfully for at least 2 months through the Quebec National Program for Home Ventilatory Assistance (NPHVA).
- Phase 2:
- severe COPD with FEV1<50%; pCO2>= 52 on arterial or capillary blood gas measured 2-4 weeks after acute NIV use and discontinuation
Who cannot join
- Phase 1
- COPD exacerbation requiring treatment (including hospitalization) within the last 6 weeks; surgical procedure or major illness within the last 3 months; kyphoscoliosis, neuromuscular disease, other lung disease (e.g. fibrosis); active cancer; expected survival < 2 months; listed on the transplant list.
- Phase 2:
- any additional condition potentially predisposing to hypercapnia such as: obesity (BMI> 30kg/m2), kyphoscoliosis, neuromuscular disease, other lung disease (e.g. fibrosis), severe obstructive sleep apnea (AHI>30/h on prior testing if available, but will not test as part of the study); active cancer; expected survival < 2 months; listed on the transplant list at start of study.
Trial locations and contacts
1 site in 1 country.
About this study
In this 2-phase pilot study, the BiPAP A40 EFL will be evaluated in patients with severe COPD requiring home non-invasive ventilatory support with respect to patient-related and physiologic outcomes.
Read the detailed description
Objective phase 1: in patients with COPD already established on home NIV, to assess the effect of 2 months of the A40EFL on ventilator parameters, physiologic and patient-related outcomes (PRO), in comparison to the patients' usual settings as prescribed by their treating physician.
The two primary outcomes will be the nightly duration of NIV use and NIV-related symptoms (S3-NIV questionnaire). Patient preference will be a secondary outcome.
Objective phase 2 : In hypercapnic patients with COPD with a prior hypercapnic exacerbation requiring NIV in hospital, to obtain preliminary data regarding the impact of home NIV using the A40EFL on COPD exacerbations and physiologic and patient-related outcomes.
The primary outcome will be the number of hospitalizations over 12 months on A40EFL.
Secondary outcomes will include descriptive data on number of exacerbations not requiring hospitalization but treated with antibiotics or prednisone.
Additional secondary outcomes, physiologic and PRO, for both phases 1 \& 2, will be evaluated.
- Conditions
- COPD
- Being tested
- BiPAP EFL
- 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.
BiPAP EFLDevice
Non-invasive ventilation using a novel ventilatory mode targeting expiratory flow limitation in COPD
| Study group | Role | What they receive |
|---|---|---|
| BPAP EFL | Experimental | Phase 1: use device for 2 months
Phase 2: use device for 12 months Receives: Device: BiPAP EFL |
What is being measured
The primary outcome is the main question the study is designed to answer.
The nightly duration of Non-Invasive Ventilation use
(Phase 1)
Measured in hours and minutes.
Measured: 2 months
S3-NIV (Non-Invasive Ventilation) questionnaire score
NIV-related symptoms (Phase 1) Dupuis-Lozeron E, Gex G, Pasquina P, et al. Development and validation of a simple tool for the assessment of home noninvasive ventilation: the S3-NIV questionnaire. Eur Respir J 2018; 52: 1801182.
The lowest score corresponds to highest adverse impact of disease and treatment.
Measured: 2 months
The number of hospitalizations during the study period, compared with year prior to inclusion
(phase 2)
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 posted5 Nov 2021
- Study startOct 2025 (estimated)
- Primary completionDec 2027 (estimated)
- Study completionDec 2027 (estimated)
Why it stopped: Devices not available
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 McGill University Health Centre/Research Institute of the McGill University Health CentreThe 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 48 participants (estimated)
Sponsor and investigators
- Lead sponsor
- McGill University Health Centre/Research Institute of the McGill University Health Centre
- Sponsor type
- University, hospital or other
- Collaborators
- University of Calgary
- Responsible party
- Principal investigator, Marta Kaminska, McGill University Health Centre/Research Institute of the McGill University Health Centre
- Investigators
- Marta Kaminska, MD, MSc, Principal investigator, McGill University Health Centre/Research Institute of the McGill University Health Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05109754
- Sponsor's protocol ID
- 2022-8261
- Status last verified
- Mar 2024
- First submitted
- 27 Oct 2021
- Last updated
- 15 Mar 2024
- 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 15 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Home Non-Invasive Ventilation Targeting Expiratory Flow Limitation in Severe Hypercapnic COPD.
- ClinicalTrials.gov ID
- NCT05109754
- Acronym / sponsor ID
- 2022-8261
- Conditions
- COPD
- Study type
- Interventional
- Recruitment status
- SuspendedReason stopped: Devices not available
- Enrolment
- 48 participants (estimated)
- Lead sponsor
- McGill University Health Centre/Research Institute of the McGill University Health CentreUniversity, hospital or other
- Collaborators
- University of Calgary
- Study start
- Oct 2025 (estimated)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 5 Nov 2021 (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.
In this 2-phase pilot study, the BiPAP A40 EFL will be evaluated in patients with severe COPD requiring home non-invasive ventilatory support with respect to patient-related and physiologic outcomes.
Detailed description
Objective phase 1: in patients with COPD already established on home NIV, to assess the effect of 2 months of the A40EFL on ventilator parameters, physiologic and patient-related outcomes (PRO), in comparison to the patients' usual settings as prescribed by their treating physician.
The two primary outcomes will be the nightly duration of NIV use and NIV-related symptoms (S3-NIV questionnaire). Patient preference will be a secondary outcome.
Objective phase 2 : In hypercapnic patients with COPD with a prior hypercapnic exacerbation requiring NIV in hospital, to obtain preliminary data regarding the impact of home NIV using the A40EFL on COPD exacerbations and physiologic and patient-related outcomes.
The primary outcome will be the number of hospitalizations over 12 months on A40EFL.
Secondary outcomes will include descriptive data on number of exacerbations not requiring hospitalization but treated with antibiotics or prednisone.
Additional secondary outcomes, physiologic and PRO, for both phases 1 \& 2, will be evaluated.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| BPAP EFL | Experimental | Device: BiPAP EFLPhase 1: use device for 2 months Phase 2: use device for 12 months |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Phase 1:
- severe COPD with FEV1<50%, using home NIV successfully for at least 2 months through the Quebec National Program for Home Ventilatory Assistance (NPHVA).
- Phase 2:
- severe COPD with FEV1<50%; pCO2>= 52 on arterial or capillary blood gas measured 2-4 weeks after acute NIV use and discontinuation
Key exclusion criteria (4 listed)
- Phase 1
- COPD exacerbation requiring treatment (including hospitalization) within the last 6 weeks; surgical procedure or major illness within the last 3 months; kyphoscoliosis, neuromuscular disease, other lung disease (e.g. fibrosis); active cancer; expected survival < 2 months; listed on the transplant list.
- Phase 2:
- any additional condition potentially predisposing to hypercapnia such as: obesity (BMI> 30kg/m2), kyphoscoliosis, neuromuscular disease, other lung disease (e.g. fibrosis), severe obstructive sleep apnea (AHI>30/h on prior testing if available, but will not test as part of the study); active cancer; expected survival < 2 months; listed on the transplant list at start of study.
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 |
|---|---|---|
| BiPAP EFLNon-invasive ventilation using a novel ventilatory mode targeting expiratory flow limitation in COPD | Device | BPAP EFL |
Primary outcome
The nightly duration of Non-Invasive Ventilation use
Time frame: 2 months
(Phase 1) Measured in hours and minutes.
S3-NIV (Non-Invasive Ventilation) questionnaire score
Time frame: 2 months
NIV-related symptoms (Phase 1) Dupuis-Lozeron E, Gex G, Pasquina P, et al. Development and validation of a simple tool for the assessment of home noninvasive ventilation: the S3-NIV questionnaire. Eur Respir J 2018; 52: 1801182. The lowest score corresponds to highest adverse impact of disease and treatment.
The number of hospitalizations during the study period, compared with year prior to inclusion
Time frame: 12 months
(phase 2)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Mar 2024.
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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.
Marta Kaminska, MD, MSc principal investigator
McGill University Health Centre/Research Institute of the McGill University Health Centre
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing BiPAP EFL in people with COPD, run by McGill University Health Centre/Research Institute of the McGill University Health Centre at 1 site in Canada.
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 4 inclusion and 4 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: paused, as of the sponsor's last update on 15 Mar 2024. 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 Canada. 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?
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?
The nightly duration of Non-Invasive Ventilation use (time frame: 2 months). The study lists 3 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 15 Mar 2024.