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Determination of the Prevalence and Severity of Expiratory Flow Limitation in Chronic Obstructive Pulmonary Disease Patients
trial testing Vector ventilator in Chronic Obstructive Pulmonary Disease in 57 participants. Terminated before completion.
| Lead sponsor | Philips Respironics |
|---|---|
| Status | Terminated |
| Study type | INTERVENTIONAL |
| Allocation | non randomized |
| Design | sequential |
| Masking | none |
| Primary purpose | other |
| Enrollment | 57 |
| Start date | 14 March 2019 |
| Primary completion | 15 November 2023 |
| Estimated completion | 15 November 2023 |
| Sites | 1 location across United States |
Philips Respironics
Adults 40 to 80, any sex, with Chronic Obstructive Pulmonary Disease or Noninvasive Ventilation. Patients with the condition only — healthy volunteers not accepted.
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
The overall prevalence of EFL will be determined. This is defined as the percentage of participants exhibiting a DeltaXRS value greater than or equal to 2.8 using the Vector EFL device while supine. For purposes of this trial, overall prevalence includes indeterminate EFL and EFL.
| Group | Value | 95% CI |
|---|---|---|
| All Participants That Were Consented. | 25 |
Correlation of titrated final EPAP (EPAP that is determined to abolish EFL) to patients' Forced Expiratory Volume in one second (FEV1).
| Group | Value | 95% CI |
|---|---|---|
| All Participants That Were Consented. | -0.278 |
Correlation of titrated final EPAP (EPAP that is determined to abolish EFL) to participants screening DeltaXrs value
| Group | Value | 95% CI |
|---|---|---|
| All Participants That Were Consented. | -0.427 |
Percent of participants with EFL per the Resmon Pro that have their EFL abolished during the Vector screening. This will be calculated by the number of participants screened positive for EFL with the Resmon Pro who screened negative for EFL with the Vector device.
| Group | Value | 95% CI |
|---|---|---|
| All Participants That Were Consented. | 11 | |
| All Participants That Were Consented. | 8 |
| Group | Value | 95% CI |
|---|---|---|
| All Participants That Were Consented. | 6 | |
| All Participants That Were Consented. | 21 |
Time frame: All adverse events occurring during the course of the study and up to 72 hours post study visit will be collected.. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.
| Reaction | System | All Participants That Were… |
|---|---|---|
| Coughing | Respiratory, thoracic and mediastinal disorders | — |
Data from ClinicalTrials.gov NCT03851510 adverse events section.
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.
No peer-reviewed publications indexed yet for this trial.
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