Trial Outcomes & Findings for PEEP Mask for Tracheobronchomalacia-Induced Cough (NCT NCT04169282)

NCT ID: NCT04169282

Last Updated: 2023-09-28

Results Overview

The primary objective is to determine if use of the nPEP device will change cough severity. Responses to the Cough VAS range from 0-100 mm, with higher scores corresponding to worse outcomes.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 10 participants
• Primary outcome timeframe: Baseline, two weeks
• Results posted on: 2023-09-28

Participant Flow

Participant milestones

Measure	nPEP Recipients Single-patient, adjustable expiratory resistance device that provides positive pressure (5 to 20 cm H2O) during expiration nPEP (non-invasive positive expiratory pressure) mask: Positive end expiratory pressure (PEEP) mask
Overall Study STARTED	10
Overall Study COMPLETED	9
Overall Study NOT COMPLETED	1

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

PEEP Mask for Tracheobronchomalacia-Induced Cough

Baseline characteristics by cohort

Measure	nPEP Recipients n=10 Participants Single-patient, adjustable expiratory resistance device that provides positive pressure (5 to 20 cm H2O) during expiration nPEP (non-invasive positive expiratory pressure) mask: Positive end expiratory pressure (PEEP) mask
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	4 Participants n=5 Participants
Age, Categorical >=65 years	6 Participants n=5 Participants
Sex: Female, Male Female	10 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	10 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	1 Participants n=5 Participants
Race (NIH/OMB) White	9 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	10 participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline, two weeks

Population: Participants who completed the study.

The primary objective is to determine if use of the nPEP device will change cough severity. Responses to the Cough VAS range from 0-100 mm, with higher scores corresponding to worse outcomes.

Outcome measures

Measure	nPEP Recipients n=9 Participants Single-patient, adjustable expiratory resistance device that provides positive pressure (5 to 20 cm H2O) during expiration nPEP (non-invasive positive expiratory pressure) mask: Positive end expiratory pressure (PEEP) mask
Change in Cough Severity as Measured by the Cough Visual Analog Scale (VAS)	-50.67 units on a scale Standard Deviation 113.00

PRIMARY outcome

Timeframe: Baseline, two weeks

Population: Participants who completed the study.

The CQLQ score ranges from 28 to 112, with higher scores corresponding to worse outcomes.

Outcome measures

Measure	nPEP Recipients n=9 Participants Single-patient, adjustable expiratory resistance device that provides positive pressure (5 to 20 cm H2O) during expiration nPEP (non-invasive positive expiratory pressure) mask: Positive end expiratory pressure (PEEP) mask
Change in Quality of Life as Measured by the Cough-Specific Quality-of-Life Questionnaire (CQLQ)	-14.63 score on a scale Standard Deviation 10.34

PRIMARY outcome

Timeframe: Baseline, two weeks

Population: Participants who completed the study.

The LCQ score ranges from 19 to 133, with lower scores corresponding to worse outcomes.

Outcome measures

Measure	nPEP Recipients n=9 Participants Single-patient, adjustable expiratory resistance device that provides positive pressure (5 to 20 cm H2O) during expiration nPEP (non-invasive positive expiratory pressure) mask: Positive end expiratory pressure (PEEP) mask
Change in Quality of Life as Measured by the Leicester Cough Questionnaire (LCQ)	2.53 score on a scale Standard Deviation 3.30

SECONDARY outcome

Timeframe: Baseline, two weeks

Population: Data not collected on one participant at two weeks.

The secondary objective is to determine if use of the nPEP device changes airway physiology, specifically proximal airway reactance, as assessed by impulse oscillometry. Reactance at 5 Hz (X5) relates to the physical properties of the lung parenchyma and its ability to expand and facilitate alveolar filling. A more negative X5 value indicates less elasticity of the lung.

Outcome measures

Measure	nPEP Recipients n=9 Participants Single-patient, adjustable expiratory resistance device that provides positive pressure (5 to 20 cm H2O) during expiration nPEP (non-invasive positive expiratory pressure) mask: Positive end expiratory pressure (PEEP) mask
Proximal Airway Reactance at 5 Hz (X5) as Assessed by Impulse Oscillometry Baseline	-3.19 cmH2O/L/sec Standard Deviation 2.10
Proximal Airway Reactance at 5 Hz (X5) as Assessed by Impulse Oscillometry Two Weeks	-3.08 cmH2O/L/sec Standard Deviation 2.37

Adverse Events

nPEP Recipients

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Loretta Que, MD

Duke University

Phone: 919-681-8551

Email: loretta.que@duke.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place