Chronic Obstructive Pulmonary DiseaseNCT04263532
Vector Efficacy Cross-Over Pilot Study
A study testing Modified BiPAP A40 with Vector Algorithm (Vector) in people with Chronic Obstructive Pulmonary Disease, run by Philips Clinical & Medical Affairs Global at 1 site in United States.
Trial summary
The study evaluates the safety and efficacy of the modified Bi-level positive airway pressure (BiPAP) A40 with Vector Algorithm to treat Chronic Obstructive Pulmonary Disease (COPD) patients with excessive carbon dioxide in their bloodstream (hypercapnia) and expiratory flow limitation (EFL), a constriction of the… Read more about this study
- Who is it for?
- Ages 40 to 80 years
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease
- What is being tested?
- Modified BiPAP A40 with Vector Algorithm (Vector)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 1 siteUnited States
- Study dates
- 21 Jan 2020to 17 Nov 2023
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 40 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age greater than or equal to 40 years of age; less than or equal to 80 years of age
- Ability to provide consent
- Chronic obstructive pulmonary disease (COPD) patients with hypercapnia (as defined as greater than or equal to 52mmHg) who are either current non-invasive ventilation (NIV) users or naïve to NIV
- On average, use NIV more than 4 hours per night (Current NIV users).
- Must present with expiratory flow limitation (EFL) via screening of the Vector device at 3 cmH2O
- Have an EPAP to abolish EFL greater or equal to 6cmH2O
Who cannot join
- Any major non-COPD uncontrolled disease or condition, such as congestive heart failure, malignancy, liver or renal insufficiency (that requires current evaluation for liver or renal transplantation or dialysis), amyotrophic lateral sclerosis, or severe stroke, or other condition as deemed appropriate by investigator as determined by review of medical history and / or participant reported medical history
- Suffering from a COPD exacerbation (Defined as hospital admission, ER/urgent care visit, MD visit with medication change or other intervention deemed to be clinically significant by the investigator at the time of data collection or in the 14 days prior to data collection
- Self-reported Pregnancy or positive pregnancy test for women of childbearing potential.
- Employee or family member that is affiliated with Philips
- Currently employed by a manufacturer of respiratory products or family member employed by a manufacturer of respiratory products
- Any history of giant bulla (size >1/3 hemi-thorax)
Show all 21Show fewer
- History of pneumothorax < 6 months
- Participants currently using a PAP or NIV device at home with a documented EPAP setting on their current device that is greater than the calculated EPAP determined during the therapy session of the screening visit (Current NIV Users).
- Life expectancy ≤12 months as determined by clinical investigator
- Low BP: Systolic <90
- Recent cranial surgery (i.e, less than 1 year)
- Impaired swallowing as reported by participant or diagnostic exam
- Recent upper airway or GI surgery within the past 6 months
- Unable to be fitted with mask
- Excessive secretions as reported by clinical investigator/physician assessment, inability to maintain a patent airway or adequately clear secretions, or at risk for aspiration of gastric contents
- Diagnosed with acute sinusitis or otitis media
- Epistaxis, causing pulmonary aspiration of blood
- Existing respiratory failure
- Participants who are naïve to NIV (Cohort 2) that use the device fewer than 3 out of 7 nights during the second week of the 2-week acclimation period
- Participants who are naïve to NIV (Cohort 2) that average less than 4 hours of device use during the second week of the 2-week acclimation period
- Participants who are naïve to NIV (Cohort 2) with an average nightly 90% EPAP pressure during the second week of the 2-week acclimation period that is higher than the titrated EFL EPAP pressure determined at the screening visit.
Trial locations and contacts
1 site in 1 country.
United States1 site
Temple University Hospital
Philadelphia, Pennsylvania, 19140
About this study
Official title: Randomized Controlled Cross-Over Pilot Study of the Effectiveness of the Vector NIV Device in Hypercapnic COPD Patients With Expiratory Flow Limitation
The study evaluates the safety and efficacy of the modified Bi-level positive airway pressure (BiPAP) A40 with Vector Algorithm to treat Chronic Obstructive Pulmonary Disease (COPD) patients with excessive carbon dioxide in their bloodstream (hypercapnia) and expiratory flow limitation (EFL), a constriction of the lower airways. The study will include current users of non-invasive ventilation (NIV) as well as those who are not currently using an NIV device.
Read the detailed description
This study is a prospective randomized controlled cross-over pilot trial to investigate the clinical efficacy and safety of the Modified Bi-level positive airway pressure (BiPAP) A40 with Vector Algorithm (Vector Device), a non-invasive ventilation (NIV) device, to treat Chronic Obstructive Pulmonary Disease (COPD). Approximately 30 COPD patients with chronic hypercapnia and evidence of expiratory flow limitation (EFL) will be included. It is estimated that 50 patients may need to be enrolled in order to complete 30. There will be two different patient cohort groups, patients that are current users of NIV and patients that are Naïve to NIV. Only those that meet the inclusion/exclusion criteria will be screened to determine if EFL is present. If participants are found to have EFL they will undergo a 20 minute EFL abolishment determination. Those participants that have EFL and a titrated expiratory positive airway pressure (EPAP) ≥6cmH2O will be scheduled for study visit 2. During study visit 2, participants will be randomized in a 1:1 ratio to receive either standard NIV (control) or Vector (Active) for the first 4 to 6-week at-home treatment period, followed by the other treatment during the second 4 to 6 weeks. Participants will have up to 4 (NIV current Users) or 5 (NIV Naïve) in-person visits that will include 2 overnight sleep studies with polysomnogram (PSG).
- Conditions
- Chronic Obstructive Pulmonary Disease
- Being tested
- Modified BiPAP A40 with Vector Algorithm (Vector), Modified BiPAP A40 with Standard of Care Settings
- 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.
Modified BiPAP A40 with Vector Algorithm (Vector)Device
The Modified BiPAP A40 with Vector Algorithm (Vector) is intended to provide non-invasive ventilatory support to treat patients weighing over 10 kg (22 lbs) with Obstructive Sleep Apnea (OSA) or Respiratory Insufficiency. It is intended to be used within the home, institutional/ hospital, and diagnostic laboratory environments. This device is not intended for life support. The BiPAP A40 EFL screening and therapy is intended for patients weighing over 30 kg (66 lbs) with Obstructive Sleep Apnea (OSA), or Respiratory Insufficiency with primary cause being Chronic Obstructive Pulmonary Disease (COPD) to screen for the presence, and abolishment of Expiratory Flow Limitation (EFL).
Modified BiPAP A40 with Standard of Care SettingsDevice
The Modified BiPAP A40 with Standard of Care settings is intended to provide non-invasive ventilatory support to treat patients weighing over 10 kg (22 lbs) with Obstructive Sleep Apnea (OSA) or Respiratory Insufficiency. It is intended to be used within the home, institutional/ hospital, and diagnostic laboratory environments. This device is not intended for life support. The BiPAP A40 EFL screening and therapy is intended for patients weighing over 30 kg (66 lbs) with Obstructive Sleep Apnea (OSA), or Respiratory Insufficiency with primary cause being Chronic Obstructive Pulmonary Disease (COPD) to screen for the presence, and abolishment of Expiratory Flow Limitation (EFL).
| Study group | Role | What they receive |
|---|---|---|
| Vector Device (NIV Current Users) | Experimental | Participants will use the Vector device with settings from the 3-hour Vector titration. Receives: Device: Modified BiPAP A40 with Vector Algorithm (Vector) |
| Standard of Care NIV (NIV Current Users) | Active comparator | Participants will use a Vector Device in place of their current NIV device. The Vector therapy will not be enabled, and the device will be set according to their current standard of care NIV prescription. Receives: Device: Modified BiPAP A40 with Standard of Care Settings |
| Vector Device (NIV Naive) | Experimental | Participants will use the Vector device with settings from the 3-hour Vector titration. Receives: Device: Modified BiPAP A40 with Vector Algorithm (Vector) |
| Standard of Care NIV (NIV Naive) | Active comparator | Participants will use the Vector device (Vector therapy will be enabled) with settings from a standard of care NIV titration. Receives: Device: Modified BiPAP A40 with Standard of Care Settings |
What is being measured
The primary outcome is the main question the study is designed to answer.
Daytime PaCO2 (Arterial Blood Gas)
Room air CO2 levels at the end of 4-6 weeks of therapy as determined by Arterial Blood Gas (PaCO2)
Measured: At the end of the 4-to-6-week period
Secondary outcomes (3)
Average 30 Day Ventilator Usage Hours
How many hours per night over 30 days that the participant uses the device.
Measured: Up to 30 days of device use
Patient Comfort and Therapy Preference Based Questionnaire Responses
Comfort data from device satisfaction/preference questionnaire after 30 days of device use. The specific question analyzed was " Which ventilator pressure settings or therapy did you prefer?" Outcome was number of participants who selected each therapy as preferred.
Measured: Up to 30 days of device use
Unanticipated Serious Adverse Device Effects (USADEs) and Serious Adverse Events (SAEs) Assessment
Incidence of Unanticipated Serious Adverse Device Effects (USADEs) and Serious Adverse Events (SAEs) for the Vector vs. the control group.
Measured: Up to 30 days of device use
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2020
- Study start21 Jan 2020
- Primary completion17 Nov 2023
- Study completion17 Nov 2023
Why it stopped: Study discontinued due to shifted business priorities.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Chronic Obstructive Pulmonary DiseaseStudies of the same condition, open and under way.
- 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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Patients who meet inclusion criteria will be randomized in a 1:1 ratio to receive either standard non-invasive ventilation (NIV) (control) or Vector (Active) for the first 4 to 6-week treatment period, followed by the other treatment during the second 4 to 6 weeks (see figure 1). There will be two different patient cohort groups, patients that are current users of NIV and patients that are Naïve to NIV.
- Masking
- None (open label)
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- Philips Clinical & Medical Affairs Global
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04263532
- Sponsor's protocol ID
- SRC-HRC-VectorEFF-2018-10377
- Status last verified
- May 2025
- First submitted
- 6 Feb 2020
- Last updated
- 9 May 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Controlled Cross-Over Pilot Study of the Effectiveness of the Vector NIV Device in Hypercapnic COPD Patients With Expiratory Flow Limitation
- ClinicalTrials.gov ID
- NCT04263532
- Acronym / sponsor ID
- SRC-HRC-VectorEFF-2018-10377
- Conditions
- Chronic Obstructive Pulmonary Disease
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Study discontinued due to shifted business priorities.
- Enrolment
- 21 participants (actual)
- Lead sponsor
- Philips Clinical & Medical Affairs GlobalIndustry (pharma, biotech, devices)
- Study start
- 21 Jan 2020 (actual)
- Primary completion
- 17 Nov 2023 (actual)
- Study completion
- 17 Nov 2023 (actual)
- First posted
- 10 Feb 2020 (actual)
- Results
- Posted 9 May 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The study evaluates the safety and efficacy of the modified Bi-level positive airway pressure (BiPAP) A40 with Vector Algorithm to treat Chronic Obstructive Pulmonary Disease (COPD) patients with excessive carbon dioxide in their bloodstream (hypercapnia) and expiratory flow limitation (EFL), a constriction of the lower airways. The study will include current users of non-invasive ventilation (NIV) as well as those who are not currently using an NIV device.
Detailed description
This study is a prospective randomized controlled cross-over pilot trial to investigate the clinical efficacy and safety of the Modified Bi-level positive airway pressure (BiPAP) A40 with Vector Algorithm (Vector Device), a non-invasive ventilation (NIV) device, to treat Chronic Obstructive Pulmonary Disease (COPD). Approximately 30 COPD patients with chronic hypercapnia and evidence of expiratory flow limitation (EFL) will be included. It is estimated that 50 patients may need to be enrolled in order to complete 30. There will be two different patient cohort groups, patients that are current users of NIV and patients that are Naïve to NIV. Only those that meet the inclusion/exclusion criteria will be screened to determine if EFL is present. If participants are found to have EFL they will undergo a 20 minute EFL abolishment determination. Those participants that have EFL and a titrated expiratory positive airway pressure (EPAP) ≥6cmH2O will be scheduled for study visit 2. During study visit 2, participants will be randomized in a 1:1 ratio to receive either standard NIV (control) or Vector (Active) for the first 4 to 6-week at-home treatment period, followed by the other treatment during the second 4 to 6 weeks. Participants will have up to 4 (NIV current Users) or 5 (NIV Naïve) in-person visits that will include 2 overnight sleep studies with polysomnogram (PSG).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 4
- Model description
- Patients who meet inclusion criteria will be randomized in a 1:1 ratio to receive either standard non-invasive ventilation (NIV) (control) or Vector (Active) for the first 4 to 6-week treatment period, followed by the other treatment during the second 4 to 6 weeks (see figure 1). There will be two different patient cohort groups, patients that are current users of NIV and patients that are Naïve to NIV.
| Arm | Type | Receives |
|---|---|---|
| Vector Device (NIV Current Users) | Experimental | Device: Modified BiPAP A40 with Vector Algorithm (Vector)Participants will use the Vector device with settings from the 3-hour Vector titration. |
| Standard of Care NIV (NIV Current Users) | Active comparator | Device: Modified BiPAP A40 with Standard of Care SettingsParticipants will use a Vector Device in place of their current NIV device. The Vector therapy will not be enabled, and the device will be set according to their current standard of care NIV prescription. |
| Vector Device (NIV Naive) | Experimental | Device: Modified BiPAP A40 with Vector Algorithm (Vector)Participants will use the Vector device with settings from the 3-hour Vector titration. |
| Standard of Care NIV (NIV Naive) | Active comparator | Device: Modified BiPAP A40 with Standard of Care SettingsParticipants will use the Vector device (Vector therapy will be enabled) with settings from a standard of care NIV titration. |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age greater than or equal to 40 years of age; less than or equal to 80 years of age
- Ability to provide consent
- Chronic obstructive pulmonary disease (COPD) patients with hypercapnia (as defined as greater than or equal to 52mmHg) who are either current non-invasive ventilation (NIV) users or naïve to NIV
- On average, use NIV more than 4 hours per night (Current NIV users).
- Must present with expiratory flow limitation (EFL) via screening of the Vector device at 3 cmH2O
Key exclusion criteria (21 listed)
- Any major non-COPD uncontrolled disease or condition, such as congestive heart failure, malignancy, liver or renal insufficiency (that requires current evaluation for liver or renal transplantation or dialysis), amyotrophic lateral sclerosis, or severe stroke, or other condition as deemed appropriate by investigator as determined by review of medical history and / or participant reported medical history
- Suffering from a COPD exacerbation (Defined as hospital admission, ER/urgent care visit, MD visit with medication change or other intervention deemed to be clinically significant by the investigator at the time of data collection or in the 14 days prior to data collection
- Self-reported Pregnancy or positive pregnancy test for women of childbearing potential.
- Employee or family member that is affiliated with Philips
- Currently employed by a manufacturer of respiratory products or family member employed by a manufacturer of respiratory products
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 |
|---|---|---|
| Modified BiPAP A40 with Vector Algorithm (Vector)The Modified BiPAP A40 with Vector Algorithm (Vector) is intended to provide non-invasive ventilatory support to treat patients weighing over 10 kg (22 lbs) with Obstructive Sleep Apnea (OSA) or Respiratory Insufficiency. It is intended to be used within the home, institutional/ hospital, and diagnostic laboratory environments. This device is not intended for life support. The BiPAP A40 EFL screening and therapy is intended for patients weighing over 30 kg (66 lbs) with Obstructive Sleep Apnea (OSA), or Respiratory Insufficiency with primary cause being Chronic Obstructive Pulmonary Disease (COPD) to screen for the presence, and abolishment of Expiratory Flow Limitation (EFL). | Device | Vector Device (NIV Current Users), Vector Device (NIV Naive) |
| Modified BiPAP A40 with Standard of Care SettingsThe Modified BiPAP A40 with Standard of Care settings is intended to provide non-invasive ventilatory support to treat patients weighing over 10 kg (22 lbs) with Obstructive Sleep Apnea (OSA) or Respiratory Insufficiency. It is intended to be used within the home, institutional/ hospital, and diagnostic laboratory environments. This device is not intended for life support. The BiPAP A40 EFL screening and therapy is intended for patients weighing over 30 kg (66 lbs) with Obstructive Sleep Apnea (OSA), or Respiratory Insufficiency with primary cause being Chronic Obstructive Pulmonary Disease (COPD) to screen for the presence, and abolishment of Expiratory Flow Limitation (EFL). | Device | Standard of Care NIV (NIV Current Users), Standard of Care NIV (NIV Naive) |
Primary outcome
Daytime PaCO2 (Arterial Blood Gas)
Time frame: At the end of the 4-to-6-week period
Room air CO2 levels at the end of 4-6 weeks of therapy as determined by Arterial Blood Gas (PaCO2)
3 secondary outcomes
Average 30 Day Ventilator Usage Hours
Time frame: Up to 30 days of device use
Patient Comfort and Therapy Preference Based Questionnaire Responses
Time frame: Up to 30 days of device use
Unanticipated Serious Adverse Device Effects (USADEs) and Serious Adverse Events (SAEs) Assessment
Time frame: Up to 30 days of device use
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 May 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Modified BiPAP A40 with Vector Algorithm (Vector) in people with Chronic Obstructive Pulmonary Disease, run by Philips Clinical & Medical Affairs Global at 1 site in United States.
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 6 inclusion and 21 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 9 May 2025. 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 United States. 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?
Yes. Results are posted in the registry (first posted 9 May 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Daytime PaCO2 (Arterial Blood Gas) (time frame: At the end of the 4-to-6-week period). 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 9 May 2025; AzTrials last refreshed its copy on 27 Oct 2026.