Airflow Obstruction, Chronic, Chronic Obstructive Airway Disease, Chronic Obstructive Lung Disease, Pulmonary Disease, Chronic Obstructive
Conditions
Brief summary
The Breathe NIOV™ System will reduce the work of breathing in subjects with chronic respiratory insufficiency who require long-term oxygen therapy (LTOT). The Breathe system will accomplish this by providing oxygen under pressure and augmenting the subject's spontaneous tidal volumes. The combination of efficient oxygen delivery, assisted ventilation, and a comfortable low-profile device, will result in a mean improvement in perceived well-being and ability to perform ADLs, as measured by patient-reported outcome (PRO) instruments.
Detailed description
This will be a prospective, open-label, crossover study in up to 12 stable subjects with chronic respiratory insufficiency who require LTOT. Each subject's standard oxygen therapy will be used as the control treatment and compared to the test ventilator system during selected activities of daily living. Subjects will participate in the study for up to 9 home visits, with Visits 1 and 2 each lasting for approximately 4 hours, and Visits 3-9 lasting approximately 1-2 hours each. Subjects may discontinue study participation at any time.
Interventions
DEVICENIOV System
Each subject's standard oxygen therapy will be used as the control treatment and compared to the test ventilator (NIOV) system during selected activities of daily living.
DEVICEStandard Oxygen Cannula
Supplemental oxygen via a standard oxygen cannula connected to a portable oxygen cylinder
Sponsors
Breathe Technologies, Inc.
Study design
Allocation
NON_RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
21 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Adult male and female subjects, 21-80 years of age * Diagnosis of chronic respiratory insufficiency including COPD and interstitial lung disease * Requires use of continuous nasal oxygen of at least 2 lpm * Reports limitation of activity due to fatigue or breathlessness * Fluent in written and spoken English language * Ability to be properly fitted with the Breathe nasal mask * Ability to tolerate and be appropriately titrated on the Breathe ventilator * Ability to communicate self-assessment of dyspnea, comfort, and fatigue * Ability and willingness to participate in the study including walking and other activities of daily living * Ability to provide written informed consent
Exclusion criteria
* Recent history of frequent or severe epistaxis * Symptoms of acute respiratory exacerbation within 48 hours of Study Day 1 * Discharge from the hospital within 30 days of study enrollment * Subjects, who in the opinion of the Investigator, are not suitable candidates for enrollment or who are unlikely to be able to comply with trial requirements * Subjects with conditions that, in the Investigator's opinion, contraindicates study participation
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Activity Endurance Time | Measured during single day study visit | Time in minutes of sustained activity while using test treatments |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Arterial Oxygen Saturation | Measured during activity testing in a single day study visit | O2 saturation measured by pulse oximetry |
| Borg Dyspnea Score | Measured during activity testing in a single day study visit | Borg Dyspnea score is measured using a 11-point visual analog scale. The lower the score on the scale, the less breathlessness patient experiences. The score ranges from: 0 = No breathlessness at all, representing better outcome 10 = Maximum, representing worse outcome |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Overall Study Group All subjects participating in 2-way crossover design study | 30 |
| Total | 30 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Standard Oxygen Therapy | Withdrawal by Subject | 1 |
Baseline characteristics
| Characteristic | Overall Study Group |
|---|---|
| Age, Continuous | 72 years STANDARD_DEVIATION 6.3 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 4 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 26 Participants |
| Region of Enrollment United States | 30 participants |
| Sex: Female, Male Female | 18 Participants |
| Sex: Female, Male Male | 12 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 29 | 0 / 29 |
| serious Total, serious adverse events | 0 / 29 | 0 / 29 |
Outcome results
Primary
Activity Endurance Time
Time in minutes of sustained activity while using test treatments
Time frame: Measured during single day study visit
Population: Per Protocol
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Standard Oxygen Therapy | Activity Endurance Time | 7.24 minutes | Standard Deviation 5.21 |
| Breathe NIOV System | Activity Endurance Time | 13.38 minutes | Standard Deviation 7.5 |
Comparison: A sample size of 26 patient pairs was determined based on the assumption of a true treatment difference in mean ADL endurance time of 4 ± 7 minutes using a two-tailed, paired t test (α=0.05, power=0.80).p-value: <0.0595% CI: [2, 10]t-test, 2 sided
Secondary
Arterial Oxygen Saturation
O2 saturation measured by pulse oximetry
Time frame: Measured during activity testing in a single day study visit
Population: Per Protocol
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Standard Oxygen Therapy | Arterial Oxygen Saturation | 90.65 percentage of oxyHb saturation | Standard Deviation 4.87 |
| Breathe NIOV System | Arterial Oxygen Saturation | 94.78 percentage of oxyHb saturation | Standard Deviation 1.99 |
Comparison: Two-tailed t testp-value: <0.0595% CI: [1, 7]t-test, 2 sided
Secondary
Borg Dyspnea Score
Borg Dyspnea score is measured using a 11-point visual analog scale. The lower the score on the scale, the less breathlessness patient experiences. The score ranges from: 0 = No breathlessness at all, representing better outcome 10 = Maximum, representing worse outcome
Time frame: Measured during activity testing in a single day study visit
Population: Per Protocol
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Standard Oxygen Therapy | Borg Dyspnea Score | 3 units on a scale |
| Breathe NIOV System | Borg Dyspnea Score | 1 units on a scale |