Trial Outcomes & Findings for Non-invasive Ventilation System in Moderate-to-Severe Chronic Obstructive Pulmonary Disease (COPD) (NCT NCT01355978)

NCT ID: NCT01355978

Last Updated: 2016-10-12

Results Overview

Evaluate the mean test volume for three activity levels. Subjects completed five consecutive, 6-hour clinic days in which the NIOV system was worn continuously while at rest, during activities of daily living (ADLs).

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 22 participants
• Primary outcome timeframe: Periodically over six hours x 5 days
• Results posted on: 2016-10-12

Participant Flow

Participant milestones

Measure	Noninvasive Open Ventilation System Portable noninvasive open ventilator \& nasal interface. Noninvasive Open Ventilation System: Noninvasive ventilation system
Overall Study STARTED	22
Overall Study COMPLETED	18
Overall Study NOT COMPLETED	4

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Non-invasive Ventilation System in Moderate-to-Severe Chronic Obstructive Pulmonary Disease (COPD)

Baseline characteristics by cohort

Measure	Noninvasive Open Ventilation System n=18 Participants Portable noninvasive open ventilator \& nasal interface. Noninvasive Open Ventilation System used during activities of daily living.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	5 Participants n=5 Participants
Age, Categorical >=65 years	13 Participants n=5 Participants
Sex: Female, Male Female	9 Participants n=5 Participants
Sex: Female, Male Male	9 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	0 Participants n=5 Participants
Race (NIH/OMB) White	18 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	18 participants n=5 Participants

PRIMARY outcome

Timeframe: Periodically over six hours x 5 days

Evaluate the mean test volume for three activity levels. Subjects completed five consecutive, 6-hour clinic days in which the NIOV system was worn continuously while at rest, during activities of daily living (ADLs).

Outcome measures

Measure	Noninvasive Open Ventilation System n=18 Participants Portable noninvasive open ventilator \& nasal interface. Noninvasive Open Ventilation System: Noninvasive ventilation system
Device Tidal Volume	180 mL Standard Deviation 24

SECONDARY outcome

Timeframe: At conclusion of subject's participation (up to two weeks)

5-point Likert Scale completed at the end or the 5-day study period

• Preference Scale: 5 = Max preference (Prefer to use the test device), 1 = Min preference (Do not prefer to use the test device)

Outcome measures

Measure	Noninvasive Open Ventilation System n=18 Participants Portable noninvasive open ventilator \& nasal interface. Noninvasive Open Ventilation System: Noninvasive ventilation system
Device Preference	4 units on a scale Interval 3.0 to 5.0

SECONDARY outcome

Timeframe: Continuous from Study Day 2 through Study Day 6

Any adverse events reported during he study period.

Outcome measures

Measure	Noninvasive Open Ventilation System n=18 Participants Portable noninvasive open ventilator \& nasal interface. Noninvasive Open Ventilation System: Noninvasive ventilation system
Safety and Device-related Adverse Events	3 participants

Adverse Events

Noninvasive Open Ventilation System

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Noninvasive Open Ventilation System n=18 participants at risk Portable noninvasive open ventilator \& nasal interface. Noninvasive Open Ventilation System: Noninvasive ventilation system
Skin and subcutaneous tissue disorders Rash	5.6% 1/18 • Number of events 1 • Continuously for 1 week, starting a screening visit through end of study (Day 6).
Respiratory, thoracic and mediastinal disorders Shortness of breath	5.6% 1/18 • Number of events 18 • Continuously for 1 week, starting a screening visit through end of study (Day 6).

Additional Information

Richard J. Morishige, MS, RRT

Clinical Research Consuting

Phone: 510-606-0374

Email: rjmorishige@gmail.com

Results disclosure agreements

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