Chronic Obstructive Pulmonary DiseaseNCT04419428
A40 Expiratory Flow Limitation Registry
An observational study of Chronic Obstructive Pulmonary Disease, run by Philips Clinical & Medical Affairs Global at 1 site in United Kingdom.
Trial summary
This prospective observational multicenter registry study will include adults greater than 40 years old, diagnosed with chronic obstructive pulmonary disease, requiring home noninvasive ventilation as part of standard medical care. Read more about this study
- Who is it for?
- Ages 40 to 85 years
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease
- What is being tested?
- BiPAP A40 Expiratory Flow Limitation (EFL)
- Type of treatment
- Medical device
- How many people
- 0 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Feb 2024to Sep 2025
- How long will I take part?
- 6 Months
- 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 40 to 85 years
- All sexes
- Adult, Older adult
Study population: Male and female adults greater than 40 years old, diagnosed with chronic obstructive pulmonary disease, requiring home noninvasive ventilation as part of standard medical care. For the purposes of this study, chronic obstructive pulmonary disease is defined as chronic respiratory failure consisting of historical spirometry vales (FEV1 <60% predicted and FEV1/VC < 0.7) and chronic increased daytime carbon dioxide levels greater than 6.0 kPa or 45 mmHg. In addition, participants diagnosed with major organ system diseases or obstructive sleep apnea will be excluded. At least 100 men and women who consent and meet the inclusion/exclusion criteria will be asked to participate.
Who may be able to join
- Chronic Obstructive Pulmonary Disease
- Forced Expiratory Volume (FEV1) < 60% predicted
- Forced Expiratory Volume (FEV1) / Vital Capacity (VC) ratio < 0.7
- Greater than 40 years old
- Chronic hypercapnia (daytime carbon dioxide level PaCO2 > 6.0 kPa)
- No clinical diagnosis of Obstructive Sleep Apnea
- Smoking history > 10 pack year
- Body mass index (BMI) ≤ 35kg/m2
Who cannot join
- Hypercapnic respiratory acidosis defined as pH (measure of hydrogen ion, measure of the acidity or alkalinity of a fluid) <7.35
- Acute coronary syndrome and unstable angina
- Cognitive impairment that would prevent informed consent into the trial and/or inability to comply with the protocol
- Patients undergoing renal replacement therapy
- Patients with serious comorbidities confirming prognosis likely to be less than 12-months
- Pregnancy
- Congestive Heart Failure (CHF) with ejection fraction (EF) less than 45% determined by Echo if available
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A40 EFL Registry: A Multicenter Prospective Study to Determine the Role of Expiratory Flow Limitation (EFL) in Patients With Chronic Obstructive Pulmonary Disease (COPD) Receiving Home Mechanical Ventilation
This prospective observational multicenter registry study will include adults greater than 40 years old, diagnosed with chronic obstructive pulmonary disease, requiring home noninvasive ventilation as part of standard medical care. For the purposes of this study, chronic obstructive pulmonary disease is defined as chronic respiratory failure consisting of historical spirometry vales (FEV1 <60% predicted and FEV1/VC < 0.7) and chronic increased daytime carbon dioxide levels greater than 6.0 kPa or 45 mmHg. In addition, participants diagnosed with major organ system diseases or obstructive sleep apnea will be excluded. At least 100 men and women who consent and meet the inclusion/exclusion criteria will be asked to participate. The anticipated study duration will be 6 months. The study will involve an initial visit for the standard of care initiation of home noninvasive ventilation. At this time, potential participants will be screened for participation. If eligible once consented, medical history will be collected and baseline questionnaires related to their respiratory disease will be completed. The registry study will include 6 month of home use of the noninvasive ventilator using the BiPAP A40 EFL device. Study staff will reach out to participants on a monthly basis to review any issues, medication changes, unscheduled visits, and device data download. Additional phone calls and or visits may occur on an as needed basis if issues arise. The final visit will be an in facility visit. The primary endpoint will be the overall prevalence of Expiratory Flow Limitation (EFL) in ventilated hypercapnic COPD patients, as defined as the percentage participants exhibiting a DeltaXrs value greater than or equal to 2.8 during one or more nights of therapy.
Read the detailed description
Prospective observational multicenter registry study for chronic obstructive pulmonary disease patients who require noninvasive ventilation in the home setting as part of standard medical care. The registry includes one in person screening or baseline visit, monthly follow-up phone calls (monitoring for medication changes, unscheduled visits and adverse events) and device data downloads, and a final in person study visit.
- Conditions
- Chronic Obstructive Pulmonary Disease
- Being tested
- BiPAP A40 Expiratory Flow Limitation (EFL)
- Keywords
- Noninvasive ventilation, Daytime Hypercapnia
- 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 A40 Expiratory Flow Limitation (EFL)Device
All participants in the observational registry will be using the BiPAP A40 EFL noninvasive ventilator as part of standard of care and will be participating in the same follows up and data collection. The BiPAP A-40 EFL ventilator is intended to provide non-invasive ventilatory support to treat adult patients with Respiratory Insufficiency with the primary cause being COPD. It is intended to be used within the home, institution/hospital, and diagnostic laboratory environments.
What is being measured
The primary outcome is the main question the study is designed to answer.
Screening Expiratory flow limitation
Percentage of participants exhibiting an expiratory flow limitation (Delta Xrs value) greater than or equal to 2.8 at the time of screening.
Measured: Screening
Expiratory flow limitation post therapy
Percentage of participants exhibiting an expiratory flow limitation (Delta Xrs value) greater than or equal to 2.8 during one of more nights of therapy.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2020
- Study startFeb 2024 (estimated)
- Primary completionSep 2025 (estimated)
- Study completionSep 2025 (estimated)
Why it stopped: Philips placed the study on hold in August 2022 due to the awareness of a potential device functionality issue. Philips has shifted business priorities and has decided to cancel the trial.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
- Target duration
- 6 Months
Sponsor and investigators
- Lead sponsor
- Philips Clinical & Medical Affairs Global
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Michael Polkey, MD, PhD, Principal investigator, Royal Brompton & Harefield NHS Foundation Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04419428
- Sponsor's protocol ID
- SRC_HRC_VectorEUReg_2019_10820
- Status last verified
- Jan 2024
- First submitted
- 14 May 2020
- Last updated
- 19 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A40 EFL Registry: A Multicenter Prospective Study to Determine the Role of Expiratory Flow Limitation (EFL) in Patients With Chronic Obstructive Pulmonary Disease (COPD) Receiving Home Mechanical Ventilation
- ClinicalTrials.gov ID
- NCT04419428
- Acronym / sponsor ID
- SRC_HRC_VectorEUReg_2019_10820
- Conditions
- Chronic Obstructive Pulmonary Disease
- Keywords
- Noninvasive ventilation, Daytime Hypercapnia
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: Philips placed the study on hold in August 2022 due to the awareness of a potential device functionality issue. Philips has shifted business priorities and has decided to cancel the trial.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Philips Clinical & Medical Affairs GlobalIndustry (pharma, biotech, devices)
- Study start
- Feb 2024 (estimated)
- Primary completion
- Sep 2025 (estimated)
- Study completion
- Sep 2025 (estimated)
- First posted
- 5 Jun 2020 (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.
This prospective observational multicenter registry study will include adults greater than 40 years old, diagnosed with chronic obstructive pulmonary disease, requiring home noninvasive ventilation as part of standard medical care. For the purposes of this study, chronic obstructive pulmonary disease is defined as chronic respiratory failure consisting of historical spirometry vales (FEV1 <60% predicted and FEV1/VC < 0.7) and chronic increased daytime carbon dioxide levels greater than 6.0 kPa or 45 mmHg. In addition, participants diagnosed with major organ system diseases or obstructive sleep apnea will be excluded. At least 100 men and women who consent and meet the inclusion/exclusion criteria will be asked to participate. The anticipated study duration will be 6 months. The study will involve an initial visit for the standard of care initiation of home noninvasive ventilation. At this time, potential participants will be screened for participation. If eligible once consented, medical history will be collected and baseline questionnaires related to their respiratory disease will be completed. The registry study will include 6 month of home use of the noninvasive ventilator using the BiPAP A40 EFL device. Study staff will reach out to participants on a monthly basis to review any issues, medication changes, unscheduled visits, and device data download. Additional phone calls and or visits may occur on an as needed basis if issues arise. The final visit will be an in facility visit. The primary endpoint will be the overall prevalence of Expiratory Flow Limitation (EFL) in ventilated hypercapnic COPD patients, as defined as the percentage participants exhibiting a DeltaXrs value greater than or equal to 2.8 during one or more nights of therapy.
Detailed description
Prospective observational multicenter registry study for chronic obstructive pulmonary disease patients who require noninvasive ventilation in the home setting as part of standard medical care. The registry includes one in person screening or baseline visit, monthly follow-up phone calls (monitoring for medication changes, unscheduled visits and adverse events) and device data downloads, and a final in person study visit.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Target follow-up
- 6 Months
Who may qualify
- Ages
- 40 to 85 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Male and female adults greater than 40 years old, diagnosed with chronic obstructive pulmonary disease, requiring home noninvasive ventilation as part of standard medical care. For the purposes of this study, chronic obstructive pulmonary disease is defined as chronic respiratory failure consisting of historical spirometry vales (FEV1 <60% predicted and FEV1/VC < 0.7) and chronic increased daytime carbon dioxide levels greater than 6.0 kPa or 45 mmHg. In addition, participants diagnosed with major organ system diseases or obstructive sleep apnea will be excluded. At least 100 men and women who consent and meet the inclusion/exclusion criteria will be asked to participate.
Key inclusion criteria (8 listed)
- Chronic Obstructive Pulmonary Disease
- Forced Expiratory Volume (FEV1) < 60% predicted
- Forced Expiratory Volume (FEV1) / Vital Capacity (VC) ratio < 0.7
- Greater than 40 years old
- Chronic hypercapnia (daytime carbon dioxide level PaCO2 > 6.0 kPa)
Key exclusion criteria (7 listed)
- Hypercapnic respiratory acidosis defined as pH (measure of hydrogen ion, measure of the acidity or alkalinity of a fluid) <7.35
- Acute coronary syndrome and unstable angina
- Cognitive impairment that would prevent informed consent into the trial and/or inability to comply with the protocol
- Patients undergoing renal replacement therapy
- Patients with serious comorbidities confirming prognosis likely to be less than 12-months
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 A40 Expiratory Flow Limitation (EFL)All participants in the observational registry will be using the BiPAP A40 EFL noninvasive ventilator as part of standard of care and will be participating in the same follows up and data collection. The BiPAP A-40 EFL ventilator is intended to provide non-invasive ventilatory support to treat adult patients with Respiratory Insufficiency with the primary cause being COPD. It is intended to be used within the home, institution/hospital, and diagnostic laboratory environments. | Device | – |
Primary outcome
Screening Expiratory flow limitation
Time frame: Screening
Percentage of participants exhibiting an expiratory flow limitation (Delta Xrs value) greater than or equal to 2.8 at the time of screening.
Expiratory flow limitation post therapy
Time frame: 6 months
Percentage of participants exhibiting an expiratory flow limitation (Delta Xrs value) greater than or equal to 2.8 during one of more nights of therapy.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jan 2024.
- 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.
Michael Polkey, MD, PhD principal investigator
Royal Brompton & Harefield NHS Foundation Trust
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Obstructive Pulmonary Disease, run by Philips Clinical & Medical Affairs Global at 1 site in United Kingdom.
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 8 inclusion and 7 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: withdrawn, as of the sponsor's last update on 19 Jan 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 United Kingdom. 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 withdrawn before enrolling participants, so there are no results.
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?
Screening Expiratory flow limitation (time frame: Screening). 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 19 Jan 2024.