Trial Outcomes & Findings for Vitabreath Pilot in Chronic Obstructive Pulmonary Disease (COPD) Patients (NCT NCT03349437)
NCT ID: NCT03349437
Last Updated: 2019-05-08
Results Overview
Compare the average distance walked during modified 6 minute walk test (M 6MWT) by COPD participants using Pursed Lip Breathing (PLB) versus an intermittent positive airway pressure handheld device, VitaBreath.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
25 participants
Primary outcome timeframe
15 minutes
Results posted on
2019-05-08
Participant Flow
Participant milestones
| Measure |
Participants Screened
All participants that were consented.
|
Vitabreath First, Pursed Lip Breathing Second
The Philips Respironics investigational device VitaBreath is a handheld, battery powered, intermittent positive airway pressure device that is non-invasive, and provides positive airway pressure (PAP) of 18 cm water (H2O) during inspiration and 8 cm H2O on expiration, thus creating 10 cm H2O of pressure support. Pressure support is defined as the difference between inhalation pressure and exhalation pressure. The study device is intended as an adjunct therapy to relieve shortness of breath in COPD patients who experience exertion-related dyspnea to allow them to be more active. The air is delivered to the patient via a mouthpiece on the device.
|
Pursed Lip Breathing First, Vitabreath Second
Pursed lip breathing is a commonly used technique by COPD patients. That involves exhaling through tightly pressed lips and inhaling through the nose with the mouth closed.
Pursed Lip Breathing: Pursed lip breathing (PLB) is the standard of care and will be used as the control condition comparator.
|
|---|---|---|---|
|
Screening
STARTED
|
25
|
0
|
0
|
|
Screening
COMPLETED
|
20
|
0
|
0
|
|
Screening
NOT COMPLETED
|
5
|
0
|
0
|
|
Intervention
STARTED
|
0
|
10
|
10
|
|
Intervention
COMPLETED
|
0
|
10
|
10
|
|
Intervention
NOT COMPLETED
|
0
|
0
|
0
|
Reasons for withdrawal
| Measure |
Participants Screened
All participants that were consented.
|
Vitabreath First, Pursed Lip Breathing Second
The Philips Respironics investigational device VitaBreath is a handheld, battery powered, intermittent positive airway pressure device that is non-invasive, and provides positive airway pressure (PAP) of 18 cm water (H2O) during inspiration and 8 cm H2O on expiration, thus creating 10 cm H2O of pressure support. Pressure support is defined as the difference between inhalation pressure and exhalation pressure. The study device is intended as an adjunct therapy to relieve shortness of breath in COPD patients who experience exertion-related dyspnea to allow them to be more active. The air is delivered to the patient via a mouthpiece on the device.
|
Pursed Lip Breathing First, Vitabreath Second
Pursed lip breathing is a commonly used technique by COPD patients. That involves exhaling through tightly pressed lips and inhaling through the nose with the mouth closed.
Pursed Lip Breathing: Pursed lip breathing (PLB) is the standard of care and will be used as the control condition comparator.
|
|---|---|---|---|
|
Screening
Screen Fail
|
4
|
0
|
0
|
|
Screening
Withdrawn
|
1
|
0
|
0
|
Baseline Characteristics
One participant screen failed due to the results of their CT scan, and is therefore missing the baseline data that would have been collected after the scan.
Baseline characteristics by cohort
| Measure |
All Participants
n=25 Participants
All participants that were consented.
|
|---|---|
|
Age, Continuous
|
68.5 years
STANDARD_DEVIATION 7.8 • n=25 Participants
|
|
Sex: Female, Male
Female
|
8 Participants
n=25 Participants
|
|
Sex: Female, Male
Male
|
17 Participants
n=25 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=25 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
25 Participants
n=25 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=25 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=25 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=25 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=25 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=25 Participants
|
|
Race (NIH/OMB)
White
|
25 Participants
n=25 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=25 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=25 Participants
|
|
Region of Enrollment
United States
|
25 participants
n=25 Participants
|
|
Body Mass Index (BMi)
|
27.4 kg/m^2
STANDARD_DEVIATION 6.7 • n=24 Participants • One participant screen failed due to the results of their CT scan, and is therefore missing the baseline data that would have been collected after the scan.
|
|
Heart Rate (bpm)
|
81.7 beats per minute
STANDARD_DEVIATION 16.6 • n=24 Participants • One participant screen failed due to the results of their CT scan, and is therefore missing the baseline data that would have been collected after the scan
|
|
Systolic Blood Pressure (mmHg)
|
136.1 mmHg
STANDARD_DEVIATION 16.5 • n=24 Participants • One participant screen failed due to the results of their CT scan, and is therefore missing the baseline data that would have been collected after the scan
|
|
Diastolic Blood Pressure (mmHg)
|
78.5 mmHg
STANDARD_DEVIATION 8.8 • n=24 Participants • One participant screen failed due to the results of their CT scan, and is therefore missing the baseline data that would have been collected after the scan
|
|
FEV1(L)
|
1.3 Liters
STANDARD_DEVIATION 0.6 • n=24 Participants • One participant screen failed due to the results of their CT scan, and is therefore missing the baseline data that would have been collected after the scan.
|
|
FEV1 (% Predicted)
|
40.0 percentage of predicted FEV1
STANDARD_DEVIATION 16.8 • n=24 Participants • One participant screen failed due to the results of their CT scan, and is therefore missing the baseline data that would have been collected after the scan.
|
|
FVC (L)
|
6.7 Liters
STANDARD_DEVIATION 22.0 • n=24 Participants • One participant screen failed due to the results of their CT scan, and is therefore missing the baseline data that would have been collected after the scan.
|
|
FVC (% Predicted)
|
56.9 percentage of predicted FVC
STANDARD_DEVIATION 13.2 • n=24 Participants • One participant screen failed due to the results of their CT scan, and is therefore missing the baseline data that would have been collected after the scan.
|
|
Pack Years
|
58.8 packs per year
STANDARD_DEVIATION 31.4 • n=25 Participants
|
PRIMARY outcome
Timeframe: 15 minutesCompare the average distance walked during modified 6 minute walk test (M 6MWT) by COPD participants using Pursed Lip Breathing (PLB) versus an intermittent positive airway pressure handheld device, VitaBreath.
Outcome measures
| Measure |
Vitabreath Device
n=20 Participants
The Philips Respironics investigational device VitaBreath is a handheld, battery powered, intermittent positive airway pressure device that is non-invasive, and provides positive airway pressure (PAP) of 18 cm water (H2O) during inspiration and 8 cm H2O on expiration, thus creating 10 cm H2O of pressure support. Pressure support is defined as the difference between inhalation pressure and exhalation pressure. The study device is intended as an adjunct therapy to relieve shortness of breath in COPD patients who experience exertion-related dyspnea to allow them to be more active. The air is delivered to the patient via a mouthpiece on the device.
Vitabreath Device: The VitaBreath device is designed for non-continuous use only and typical device use is expected to be for 2-3 minutes. The device should only be operated for less than 10 minutes at a time. After such time, the device should be turned off for at least 30 minutes
|
Pursed Lip Breathing
n=20 Participants
Pursed lip breathing is a commonly used technique by COPD patients. That involves exhaling through tightly pressed lips and inhaling through the nose with the mouth closed.
Pursed Lip Breathing: Pursed lip breathing (PLB) is the standard of care and will be used as the control condition comparator.
|
|---|---|---|
|
Average Distance During Modified 6 Minute Walk Test
1st Hallf of M 6MWT Distance
|
128.0 meters
Standard Deviation 47.5
|
129.9 meters
Standard Deviation 43.3
|
|
Average Distance During Modified 6 Minute Walk Test
2nd half of M 6MWT Distance
|
137.5 meters
Standard Deviation 49.7
|
121.3 meters
Standard Deviation 38.9
|
|
Average Distance During Modified 6 Minute Walk Test
Total M 6 MWT Distance
|
265.5 meters
Standard Deviation 96.3
|
251.2 meters
Standard Deviation 80.8
|
Adverse Events
Participants Screened
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Vitabreath First, Pursed Lip Breathing Second
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Pursed Lip Breathing First, Vitabreath Second
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
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place