A40 Expiratory Flow Limitation Registry

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.

Study Overview

• Status: Withdrawn
• Conditions: Chronic Obstructive Pulmonary Disease
• Intervention / Treatment: Device: BiPAP A40 Expiratory Flow Limitation (EFL)

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 Type: Observational

Contacts and Locations

Study Locations

• United Kingdom
  • London, United Kingdom, SW3 6NP
    • Royal Brompton Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A

• Sampling Method: Non-Probability Sample

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.

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	6 months

Collaborators and Investigators

• Sponsor: Philips Clinical & Medical Affairs Global
• Investigators: Principal Investigator: Michael Polkey, MD, PhD, Royal Brompton & Harefield NHS Foundation Trust

Study record dates

Study Major Dates

• Study Start (Estimated): February 1, 2024
• Primary Completion (Estimated): September 1, 2025
• Study Completion (Estimated): September 1, 2025

Study Registration Dates

• First Submitted: May 14, 2020
• First Submitted That Met QC Criteria: June 4, 2020
• First Posted (Actual): June 5, 2020

Study Record Updates

• Last Update Posted (Estimated): January 19, 2024
• Last Update Submitted That Met QC Criteria: January 17, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Keywords: Noninvasive ventilation; Daytime Hypercapnia
• Additional Relevant MeSH Terms: Pathologic Processes; Respiratory Tract Diseases; Disease Attributes; Chronic Disease; Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
• Other Study ID Numbers: SRC_HRC_VectorEUReg_2019_10820

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes