Determination of the Prevalence and Severity of Expiratory Flow Limitation in Chronic Obstructive Pulmonary Disease Patients

Stopped early

Conditions studied: Chronic Obstructive Pulmonary Disease, Noninvasive Ventilation

In brief

Expiratory Flow Limitation (EFL) occurs when the airways become compressed, which usually results when the pressure outside the airway exceeds the pressure inside the airway. EFL can be detected using the Forced Oscillation Technique (FOT), which has been incorporated into a new screening feature in the Philips Respironics BiPAP Ventilator overall platform (Vector Non-Invasive (NIV) device). In this study, the Vector device will be used in a cross-sectional non-randomized epidemiology study to assess the prevalence and severity of expiratory flow limitation in a community COPD population. The study will also investigate how the presence of EFL may correlate with other physiological biomarker endpoints in the COPD patient. Participants will include 100 male and females with a diagnosis of COPD between the ages of 40 and 80. During the one-visit study, participants will undergo an EFL screening using the Vector device. If EFL is not detected during the screening after 5 minutes, the participant will not continue. If EFL is detected by the device, the participant will continue to wear it while it measures the level of therapy that is needed to eliminate EFL. Twenty minutes of pressure therapy will then be provided and the final Expiratory Positive Airway Pressure (EPAP) that is determined to abolish the participants EFL will be recorded. Participant characteristics (e.g. health history, behaviors, anthropometric, vitals, etc.) will be also be collected via questionnaires, medical record review, and physical exam. Future benefits of the study will be to gain a better understanding of the Vector screening feature and the characteristics of patients who present with varying degrees of EFL severity.

Key facts

Study ID

NCT03851510

Run by

Philips Respironics

People needed

57

Starts

2019-03-14

Expected to finish

2023-11-15

Last updated by the study team

2024-10-24

Who can join

Age: 40 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Age > 40 years of age; < 80 years of age
• Ability to provide consent
• Diagnosis of Chronic Obstructive Pulmonary Disease (COPD)

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 at the time of data collection or in the 30 days prior to data collection
• Self-reported Pregnancy
• Employee or family member that is affiliated with Philips Respironics
• History of bullous emphysema
• History of pneumothorax
• Evidence of acute sinusitis or otitis media
• Hypotension
• Participants at risk for aspiration of gastric contents
• Epistaxis
• Participants in respiratory failure
• Inability to maintain a patent airway or adequately clear secretions

Where it is running

• University of Florida, Jacksonville — Jacksonville, Florida, United States

Full record on ClinicalTrials.gov

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