Airflow Obstruction, Chronic, Chronic Obstructive Airway Disease, Chronic Obstructive Lung Disease, Pulmonary Disease, Chronic Obstructive
Conditions
Brief summary
When using the Breathe Technologies Ventilation System during simulated activities of daily living (ADLs), Subjects with moderate-to-severe chronic obstructive pulmonary Disease (COPD) will be comfortable and report acceptability.
Detailed description
The primary objective of the study was to evaluate the Breathe Technologies Ventilator System with regard to subject acceptability, comfort, and effect on exercise and activities of daily living tolerance. Primary Hypothesis: 1. When using the Breathe Technologies Ventilation System during simulated activities of daily living (ADL), Subjects with moderate-to-severe COPD will be comfortable and report acceptability. Secondary Hypotheses: 2. When using the Breathe Technologies Ventilation System during simulated ADLs, Subjects with moderate-to-severe COPD will experience tolerable dyspnea as measured using the Borg Dyspnea Score (BDS) and a visual analog Comfort Scale (VACS). 3. Subjects will prefer using the Breathe Technologies Ventilation System over standard oxygen therapy during exertion and during ADLs after using the ventilator therapy for five days.
Interventions
DEVICENoninvasive Open Ventilation System
Noninvasive ventilation system
Sponsors
Breathe Technologies, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
21 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Have participated and completed the NOVEL 1 or NOVEL 2 studies. * Be 21-80 years of age (inclusive) at time of informed consent. * Require nasal oxygen of ≥ 2 LPM during exertion, and ≥ 1 LPM at rest. * Exhibit dyspnea and have lung disease process dominated by COPD per the Study Investigator. * Have a self-reported MMRC Dyspnea Score ≥ 2 on a scale of 0-4. * Have spirometric evidence of COPD with an FEV1 of \< 50% predicted and FEV1/FVC \< 0.70, measured within the last 6 months (GOLD stage III and IV). * Have a resting respiratory rate of less than or equal to 30 bpm. * Be fluent in reading and speaking the English language. * Be able to clearly communicate and to indicate a self-assessment of dyspnea and/or fatigue. * Be willing and able to participate in, and to complete all required study procedures, including the ability to pull an E-sized oxygen cylinder. * Report having a smoking history of ≥ 10 pack-years. * Provide written informed consent to participate in the study.
Exclusion criteria
Subject must NOT meet any of the following criteria, or they will be excluded from study participation: * Be a current tobacco smoker * Have a history of pneumothorax in last 2 years. * Have a history of severe, giant bullae. * Have a history of unstable angina * Reports the onset of cardiac arrhythmia(s) within the past 7 days. * Report having serious epistaxis within the last 10 days. * Have a history of severe pulmonary hypertension and/or NYHA Stage III and IV decompensated heart failure. * Reports symptoms of acute COPD exacerbation within the past 48 hours. * Have been discharged from the hospital within 30 days of screening for infection or acute illness or COPD exacerbation. * Have a prescription or history of requiring \> 8 LPM oxygen during exertion. * Have a history of serious allergic airways disease (e.g., high eosinophil count or elevated IgE). * Report or have evidence of LVEF \< 30 % * Have a BMI \> 40 * Have a history of thoracotomy, sternotomy, major cardiopulmonary intervention (e.g., lung resection, open heart surgery), or any procedure 6 months before study entry likely to cause instability of pulmonary status. * Have a history of lung disease unrelated to smoking that affects oxygenation or survival. * Is participating in another intervention study or have participated within 90 days of enrollment. * Have endobronchial valves or other bronchial tree implants such as stents. * Have a disease or condition expected to cause death, inability to perform procedures for the trial, or inability to comply with the therapy. * Have a history of intolerance to oxygen therapy.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Device Tidal Volume | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Device Preference | 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) |
| Safety and Device-related Adverse Events | Continuous from Study Day 2 through Study Day 6 | Any adverse events reported during he study period. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Noninvasive Open Ventilation System Portable noninvasive open ventilator & nasal interface. Noninvasive Open Ventilation System used during activities of daily living. | 18 |
| Total | 18 |
Baseline characteristics
| Characteristic | Noninvasive Open Ventilation System |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 13 Participants |
| Age, Categorical Between 18 and 65 years | 5 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 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 | 18 Participants |
| Region of Enrollment United States | 18 participants |
| Sex: Female, Male Female | 9 Participants |
| Sex: Female, Male Male | 9 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 3 / 18 |
| serious Total, serious adverse events | 0 / 18 |
Outcome results
Primary
Device Tidal Volume
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).
Time frame: Periodically over six hours x 5 days
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Noninvasive Open Ventilation System | Device Tidal Volume | 180 mL | Standard Deviation 24 |
Secondary
Device Preference
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)
Time frame: At conclusion of subject's participation (up to two weeks)
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Noninvasive Open Ventilation System | Device Preference | 4 units on a scale |
Secondary
Safety and Device-related Adverse Events
Any adverse events reported during he study period.
Time frame: Continuous from Study Day 2 through Study Day 6
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Noninvasive Open Ventilation System | Safety and Device-related Adverse Events | 3 participants |