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A40 Expiratory Flow Limitation Registry

Studies

Study First Submitted Date 2020-05-14
Study First Posted Date 2020-06-05
Last Update Posted Date 2023-04-27
Start Month Year February 2024
Primary Completion Month Year September 2025
Verification Month Year April 2023
Verification Date 2023-04-30
Last Update Posted Date 2023-04-27

Detailed Descriptions

Sequence: 20667094
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.

Facilities

Sequence: 199494649
Name Royal Brompton Hospital
City London
Zip SW3 6NP
Country United Kingdom

Facility Contacts

Sequence: 28040631
Facility Id 199494649
Contact Type primary
Name Michael Polkey, MD, PhD
Email M.Polkey@rbht.nhs.uk
Phone 0044 20 7352 8121

Conditions

Sequence: 52028950
Name Chronic Obstructive Pulmonary Disease
Downcase Name chronic obstructive pulmonary disease

Id Information

Sequence: 40047004
Id Source org_study_id
Id Value SRC_HRC_VectorEUReg_2019_10820

Countries

Sequence: 42444431
Name United Kingdom
Removed False

Interventions

Sequence: 52341095
Intervention Type Device
Name BiPAP A40 Expiratory Flow Limitation (EFL)
Description 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.

Keywords

Sequence: 79638806 Sequence: 79638807
Name Noninvasive ventilation Name Daytime Hypercapnia
Downcase Name noninvasive ventilation Downcase Name daytime hypercapnia

Design Outcomes

Sequence: 176886593 Sequence: 176886594
Outcome Type primary Outcome Type primary
Measure Screening Expiratory flow limitation Measure Expiratory flow limitation post therapy
Time Frame Screening Time Frame 6 months
Description Percentage of participants exhibiting an expiratory flow limitation (Delta Xrs value) greater than or equal to 2.8 at the time of screening. Description 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.

Browse Conditions

Sequence: 192921525 Sequence: 192921526 Sequence: 192921527 Sequence: 192921528 Sequence: 192921529 Sequence: 192921530 Sequence: 192921531
Mesh Term Lung Diseases Mesh Term Lung Diseases, Obstructive Mesh Term Pulmonary Disease, Chronic Obstructive Mesh Term Respiratory Tract Diseases Mesh Term Chronic Disease Mesh Term Disease Attributes Mesh Term Pathologic Processes
Downcase Mesh Term lung diseases Downcase Mesh Term lung diseases, obstructive Downcase Mesh Term pulmonary disease, chronic obstructive Downcase Mesh Term respiratory tract diseases Downcase Mesh Term chronic disease Downcase Mesh Term disease attributes Downcase Mesh Term pathologic processes
Mesh Type mesh-list Mesh Type mesh-list Mesh Type mesh-list Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor

Sponsors

Sequence: 48186420
Agency Class INDUSTRY
Lead Or Collaborator lead
Name Philips Clinical & Medical Affairs Global

Overall Officials

Sequence: 29203149
Role Principal Investigator
Name Michael Polkey, MD, PhD
Affiliation Royal Brompton & Harefield NHS Foundation Trust

Central Contacts

Sequence: 11977812 Sequence: 11977813
Contact Type primary Contact Type backup
Name Lynn Ostrowski, BSN, RN Name Chuck Cain, BS
Phone 412-542-3709 Phone 412-542-3605
Email lynn.ostrowski@philips.com Email chuck.cain@philips.com
Role Contact Role Contact

Eligibilities

Sequence: 30681832
Sampling Method Non-Probability Sample
Gender All
Minimum Age 40 Years
Maximum Age 85 Years
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.
Criteria 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
Adult True
Child False
Older Adult True

Calculated Values

Sequence: 253882368
Number Of Facilities 1
Registered In Calendar Year 2020
Were Results Reported False
Has Us Facility False
Has Single Facility True
Minimum Age Num 40
Maximum Age Num 85
Minimum Age Unit Years
Maximum Age Unit Years
Number Of Primary Outcomes To Measure 2

Designs

Sequence: 30428565
Observational Model Case-Only
Time Perspective Prospective

Responsible Parties

Sequence: 28795078
Responsible Party Type Sponsor