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 |
| 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 |
| lynn.ostrowski@philips.com | 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 |