A40 Expiratory Flow Limitation Registry

NCT04419428 | Withdrawn

• 1 other identifier: SRC_HRC_VectorEUReg_2019_10820
• Study Type: observational
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Chronic Obstructive Pulmonary Disease

Keywords

Noninvasive ventilation; Daytime Hypercapnia

Outcome Measures

Primary Outcomes (2)

• 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

Interventions

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.

Eligibility Criteria

• Age: 40 Years - 85 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Philips Clinical & Medical Affairs Global: lead

Study Sites (1)

Royal Brompton Hospital

London, SW3 6NP, United Kingdom

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

Study Officials

• Michael Polkey, MD, PhD

  Royal Brompton & Harefield NHS Foundation Trust

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Target Duration: 6 Months
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 14, 2020
• First Posted: June 5, 2020
• Study Start: February 1, 2024
• Primary Completion: September 1, 2025
• Study Completion: September 1, 2025
• Last Updated: January 19, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)