Vector Efficacy Cross-Over Pilot Study

NCT04263532 | Terminated Results

• 1 other identifier: SRC-HRC-VectorEFF-2018-10377
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Obstructive Pulmonary Disease

Outcome Measures

Primary Outcomes (1)

• 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)

  At the end of the 4-to-6-week period

Secondary Outcomes (3)

• Average 30 Day Ventilator Usage Hours

  Up to 30 days of device use

• Patient Comfort and Therapy Preference Based Questionnaire Responses

  Up to 30 days of device use

• Unanticipated Serious Adverse Device Effects (USADEs) and Serious Adverse Events (SAEs) Assessment

  Up to 30 days of device use

Study Arms (4)

Vector Device (NIV Current Users)

EXPERIMENTAL

Participants will use the Vector device with settings from the 3-hour Vector titration.

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.

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.

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.

Device: Modified BiPAP A40 with Standard of Care Settings

Interventions

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).

Vector Device (NIV Current Users); Vector Device (NIV Naive)

Modified BiPAP A40 with Standard of Care Settings DEVICE

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).

Standard of Care NIV (NIV Current Users); Standard of Care NIV (NIV Naive)

Eligibility Criteria

• Age: 40 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)
• 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

Sponsors & Collaborators

• Philips Clinical & Medical Affairs Global: lead

Study Sites (1)

Temple University Hospital

Philadelphia, Pennsylvania, 19140, United States

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Chuck Cain
• Organization: Philips

chuck.cain@philips.com

412-657-1814

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: February 6, 2020
• First Posted: February 10, 2020
• Study Start: January 21, 2020
• Primary Completion: November 17, 2023
• Study Completion: November 17, 2023
• Last Updated: May 9, 2025
• Results First Posted: May 9, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)