Trial Outcomes & Findings for Effects of the Breathe Technologies Ventilation System in Subjects With Chronic Obstructive Pulmonary Disease (NCT NCT01372462)
NCT ID: NCT01372462
Last Updated: 2016-10-12
Results Overview
Mean differences between NIOV - oxygen, NIOV - Room Air, Nasal Cannula Oxygen, and no treatment (control).
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
15 participants
Primary outcome timeframe
Study days 1,2,3, and 4; Day 1 for no treatment; day 2 for no treatment and NIOV - Room Air and NIOV - oxygen; Day 3 for no treatment and NIOV - Room Air and NIOV - oxygen; Day 4 for NIOV - oxygen and Nasal Cannula Oxygen.
Results posted on
2016-10-12
Participant Flow
Participant milestones
| Measure |
All Study Participants
All subjects completed all 4 visit days in which they were randomized to receive which treatment to receive first: 1) NIOV - Oxygen, 2) NIOV - Room Air, 3) Oxygen Nasal Cannula, 4) No treatment.
Study days 1,2,3, and 4; Day 1 for no treatment; day 2 for no treatment and NIOV - Room Air and NIOV - oxygen; Day 3 for no treatment and NIOV - Room Air and NIOV - oxygen; Day 4 for NIOV - oxygen and Nasal Cannula Oxygen.
|
|---|---|
|
NIOV - Room Air
STARTED
|
15
|
|
NIOV - Room Air
COMPLETED
|
15
|
|
NIOV - Room Air
NOT COMPLETED
|
0
|
|
NIOV - Oxygen
STARTED
|
15
|
|
NIOV - Oxygen
COMPLETED
|
15
|
|
NIOV - Oxygen
NOT COMPLETED
|
0
|
|
Oxygen Nasal Cannula
STARTED
|
15
|
|
Oxygen Nasal Cannula
COMPLETED
|
15
|
|
Oxygen Nasal Cannula
NOT COMPLETED
|
0
|
|
No Treatment Control
STARTED
|
15
|
|
No Treatment Control
COMPLETED
|
15
|
|
No Treatment Control
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Effects of the Breathe Technologies Ventilation System in Subjects With Chronic Obstructive Pulmonary Disease
Baseline characteristics by cohort
| Measure |
Overall Study Group
n=15 Participants
Crossover design. Subject were randomized to complete all 4 study arms: 1) NIOV - Oxygen, 2) NIOV - Room Air, 3) Oxygen Nasal Cannula, 4) No treatment
|
|---|---|
|
Age, Continuous
|
65.5 years
STANDARD_DEVIATION 9.1 • n=99 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
15 Participants
n=99 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
White
|
15 Participants
n=99 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
|
Region of Enrollment
United States
|
15 participants
n=99 Participants
|
PRIMARY outcome
Timeframe: Study days 1,2,3, and 4; Day 1 for no treatment; day 2 for no treatment and NIOV - Room Air and NIOV - oxygen; Day 3 for no treatment and NIOV - Room Air and NIOV - oxygen; Day 4 for NIOV - oxygen and Nasal Cannula Oxygen.Population: Per protocol analysis
Mean differences between NIOV - oxygen, NIOV - Room Air, Nasal Cannula Oxygen, and no treatment (control).
Outcome measures
| Measure |
NIOV - Room Air
n=15 Participants
Subjects exercise using the NIOV device powered by compressed air (room air, 21% O2).
NIOV - Room Air: Noninvasive ventilation with device powered by compressed room air.
|
NIOV - Oxygen
n=15 Participants
Subjects exercise using the NIOV device powered by compressed medical oxygen (100% O2).
NIOV - Oxygen: Noninvasive ventilation with device powered by compressed medical (100%) oxygen.
|
Nasal Cannula Oxygen
n=15 Participants
Subjects exercise using a standard nasal cannula using medical oxygen (100% O2).
Nasal Cannula Oxygen: Supplemental oxygen delivered using a standard nasal cannula connected to 100% medical oxygen.
|
No Treatment
n=15 Participants
Control arm. Subjects exercise without using supplemental oxygen or NIOV.
|
|---|---|---|---|---|
|
Exercise Duration for Constant Work Rate Exercise Tests Under 4 Test Conditions
|
6.3 minutes
Standard Deviation 4.1
|
17.5 minutes
Standard Deviation 5.7
|
11.4 minutes
Standard Deviation 6.8
|
5.6 minutes
Standard Deviation 1.9
|
SECONDARY outcome
Timeframe: Outcome was measured in each of the Study day 1,2, 3 and 4. Study days 1,2,3, and 4; Day 1 for no treatment; day 2 for no treatment and NIOV - Room Air and NIOV - oxygen; Day 3 for no treatment and NIOV - Room Air and NIOV - oxygen; Day 4 for NIOV - oxygPopulation: Per Protocol
Mean differences between NIOV - oxygen, NIOV - Room Air, Nasal Cannula Oxygen, and no treatment (control).
Outcome measures
| Measure |
NIOV - Room Air
n=15 Participants
Subjects exercise using the NIOV device powered by compressed air (room air, 21% O2).
NIOV - Room Air: Noninvasive ventilation with device powered by compressed room air.
|
NIOV - Oxygen
n=15 Participants
Subjects exercise using the NIOV device powered by compressed medical oxygen (100% O2).
NIOV - Oxygen: Noninvasive ventilation with device powered by compressed medical (100%) oxygen.
|
Nasal Cannula Oxygen
n=15 Participants
Subjects exercise using a standard nasal cannula using medical oxygen (100% O2).
Nasal Cannula Oxygen: Supplemental oxygen delivered using a standard nasal cannula connected to 100% medical oxygen.
|
No Treatment
n=15 Participants
Control arm. Subjects exercise without using supplemental oxygen or NIOV.
|
|---|---|---|---|---|
|
SpO2 During Constant Workrate Exercise at Isotime
|
87.9 percentage of oxyHb saturation
Standard Deviation 3.8
|
98.5 percentage of oxyHb saturation
Standard Deviation 1.0
|
92.7 percentage of oxyHb saturation
Standard Deviation 3.9
|
88.2 percentage of oxyHb saturation
Standard Deviation 2.2
|
SECONDARY outcome
Timeframe: Outcome was measured in each Study day 1,2,3 and 4. Study days 1,2,3, and 4; Day 1 for no treatment; day 2 for no treatment and NIOV - Room Air and NIOV - oxygen; Day 3 for no treatment and NIOV - Room Air and NIOV - oxygen; Day 4 for NIOV - oxygen and NPopulation: Per Protocol
Mean differences between NIOV - oxygen, NIOV - Room Air, Nasal Cannula Oxygen, and no treatment (control) at isotime. Borg Dyspnea Score ranges in values from 0 to 10. The lower score represent better outcome. 0 = No breathlessness at all, representing better outcome 10 = Maximum breathlessness, representing worse outcome
Outcome measures
| Measure |
NIOV - Room Air
n=15 Participants
Subjects exercise using the NIOV device powered by compressed air (room air, 21% O2).
NIOV - Room Air: Noninvasive ventilation with device powered by compressed room air.
|
NIOV - Oxygen
n=15 Participants
Subjects exercise using the NIOV device powered by compressed medical oxygen (100% O2).
NIOV - Oxygen: Noninvasive ventilation with device powered by compressed medical (100%) oxygen.
|
Nasal Cannula Oxygen
n=15 Participants
Subjects exercise using a standard nasal cannula using medical oxygen (100% O2).
Nasal Cannula Oxygen: Supplemental oxygen delivered using a standard nasal cannula connected to 100% medical oxygen.
|
No Treatment
n=15 Participants
Control arm. Subjects exercise without using supplemental oxygen or NIOV.
|
|---|---|---|---|---|
|
Borg Dyspnea Score During Constant Workrate Exercise at Isotime
|
3.3 units on a scale
Standard Deviation 1.8
|
1.8 units on a scale
Standard Deviation 1.3
|
2.5 units on a scale
Standard Deviation 1.7
|
4.6 units on a scale
Standard Deviation 2.0
|
Adverse Events
NIOV - Room Air
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
NIOV - Oxygen
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Nasal Cannula Oxygen
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
No Treatment
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
Richard J. Morishige, MS, RRT
Clinical Research Consulting
Phone: 510-606-0375
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place