Trial Outcomes & Findings for Determination of the Prevalence and Severity of Expiratory Flow Limitation in Chronic Obstructive Pulmonary Disease Patients (NCT NCT03851510)

Last Updated: 2024-10-24

Results Overview

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.

Recruitment status

TERMINATED

Target enrollment

57 participants

Primary outcome timeframe

1 day

Results posted on

2024-10-24

Participant Flow

Participant milestones

Participant milestones
Measure	All Participants That Were Consented. All participants that were consented. If eligible, participants were screened for EFL with Resmon Pro and Vector devices.
Overall Study STARTED	57
Overall Study COMPLETED	54
Overall Study NOT COMPLETED	3

Reasons for withdrawal

Reasons for withdrawal
Measure	All Participants That Were Consented. All participants that were consented. If eligible, participants were screened for EFL with Resmon Pro and Vector devices.
Overall Study Screen Fail	1
Overall Study Adverse Event	1
Overall Study Withdrawal by Subject	1

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	All Participants That Were Consented. n=56 Participants All participants that were consented. If eligible, participants were screened for EFL with Resmon Pro and Vector devices.
Age, Continuous	61 years STANDARD_DEVIATION 8.1 • n=93 Participants
Sex: Female, Male Female	32 Participants n=93 Participants
Sex: Female, Male Male	24 Participants n=93 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants n=93 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	55 Participants n=93 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=93 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=93 Participants
Race (NIH/OMB) Asian	1 Participants n=93 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=93 Participants
Race (NIH/OMB) Black or African American	14 Participants n=93 Participants
Race (NIH/OMB) White	41 Participants n=93 Participants
Race (NIH/OMB) More than one race	0 Participants n=93 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=93 Participants
Region of Enrollment United States	56 participants n=93 Participants

PRIMARY outcome

Timeframe: 1 day

Population: One participant screened fail and data was not collected for the two discontinued participants.

Outcome measures

Outcome measures
Measure	All Participants That Were Consented. n=54 Participants All participants that were consented. If eligible, participants were screened for EFL with Resmon Pro and Vector devices.
Overall Prevalence of Expiratory Flow Limitation	25 Participants

SECONDARY outcome

Timeframe: 1 day

Population: Participants that were consented, eligible, screened positive for EFL, completed the titration and had spirometry data available.

Correlation of titrated final EPAP (EPAP that is determined to abolish EFL) to patients' Forced Expiratory Volume in one second (FEV1).

Outcome measures

Outcome measures
Measure	All Participants That Were Consented. n=16 Participants All participants that were consented. If eligible, participants were screened for EFL with Resmon Pro and Vector devices.
Correlation of Titrated Final EPAP to Participants' Forced Expiratory Volume in One Second (FEV1)	-0.278 Spearman rank correlation coefficient

SECONDARY outcome

Timeframe: 1 day

Population: Participants that were consented, eligible, screened positive for EFL, and completed the titration.

Correlation of titrated final EPAP (EPAP that is determined to abolish EFL) to participants screening DeltaXrs value

Outcome measures

Outcome measures
Measure	All Participants That Were Consented. n=16 Participants All participants that were consented. If eligible, participants were screened for EFL with Resmon Pro and Vector devices.
Correlation of Titrated Final EPAP to Participants' Screening DeltaXrs Value	-0.427 Spearman rank correlation coefficient

SECONDARY outcome

Timeframe: 1 day

Population: 46 participants were consented, eligible and screened for EFL with the Resmon Pro and Vector devices. Of those N=46, N=19 screened positive with the ResMon Pro device. Of those N=19, N=8 screened negative with the Vector device, resulting in 8/19 (42.1%).

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.

Outcome measures

Outcome measures
Measure	All Participants That Were Consented. n=46 Participants All participants that were consented. If eligible, participants were screened for EFL with Resmon Pro and Vector devices.
Percent of Participants With EFL Per the Resmon Pro That Have Their EFL Abolished During the Vector Screening. Participants screened positive with Resmon Pro · Participants screened positive with Vector	11 Participants
Percent of Participants With EFL Per the Resmon Pro That Have Their EFL Abolished During the Vector Screening. Participants screened positive with Resmon Pro · Participants screened negative with Vector	8 Participants
Percent of Participants With EFL Per the Resmon Pro That Have Their EFL Abolished During the Vector Screening. Participants screened negative with Resmon Pro · Participants screened positive with Vector	6 Participants
Percent of Participants With EFL Per the Resmon Pro That Have Their EFL Abolished During the Vector Screening. Participants screened negative with Resmon Pro · Participants screened negative with Vector	21 Participants

Adverse Events

All Participants That Were Consented.

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	All Participants That Were Consented. n=57 participants at risk All participants that were consented. If eligible, participants were screened for EFL with Resmon Pro and Vector devices.
Respiratory, thoracic and mediastinal disorders Coughing	1.8% 1/57 • Number of events 1 • All adverse events occurring during the course of the study and up to 72 hours post study visit will be collected.

Additional Information

Chuck Cain

Philips

Phone: 412-657-1814

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place