Clinical trial NCT04263532: Vector Efficacy Cross-Over Pilot 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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Conditions: Chronic Obstructive Pulmonary Disease
Lead sponsor: Philips Clinical & Medical Affairs Global
Sponsor class: INDUSTRY
First posted: 2020-02-10
Enrollment: 21
Sex: ALL
Minimum age (years): 40
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention 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.
Primary purpose: TREATMENT

Brief 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 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).

Eligibility criteria: Inclusion Criteria:

1. Age greater than or equal to 40 years of age; less than or equal to 80 years of age
2. Ability to provide consent
3. 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
4. On average, use NIV more than 4 hours per night (Current NIV users).
5. Must present with expiratory flow limitation (EFL) via screening of the Vector device at 3 cmH2O
6. Have an EPAP to abolish EFL greater or equal to 6cmH2O

Exclusion Criteria:

1. 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
2. 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
3. Self-reported Pregnancy or positive pregnancy test for women of childbearing potential.
4. Employee or family member that is affiliated with Philips
5. Currently employed by a manufacturer of respiratory products or family member employed by a manufacturer of respiratory products
6. Any history of giant bulla (size \>1/3 hemi-thorax)
7. History of pneumothorax \< 6 months
8. 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).
9. Life expectancy ≤12 months as determined by clinical investigator
10. Low BP: Systolic \<90
11. Recent cranial surgery (i.e, less than 1 year)
12. Impaired swallowing as reported by participant or diagnostic exam
13. Recent upper airway or GI surgery within the past 6 months
14. Unable to be fitted with mask
15. 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
16. Diagnosed with acute sinusitis or otitis media
17. Epistaxis, causing pulmonary aspiration of blood
18. Existing respiratory failure
19. 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
20. 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
21. 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.

Primary outcomes:
measure: Daytime PaCO2 (Arterial Blood Gas)
timeFrame: At the end of the 4-to-6-week period
Secondary outcomes:
measure: Average 30 Day Ventilator Usage Hours
timeFrame: Up to 30 days of device use
measure: Patient Comfort and Therapy Preference Based Questionnaire Responses
timeFrame: Up to 30 days of device use
measure: Unanticipated Serious Adverse Device Effects (USADEs) and Serious Adverse Events (SAEs) Assessment
timeFrame: Up to 30 days of device use
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Temple University Hospital
state: Pennsylvania
Study officials:
References: