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

Study Overview
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Brief Summary
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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
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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: 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: 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). 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.

Official Title
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Acceptability, Comfort, and Exercise Tolerance Using a Non-invasive Ventilation System in Patients With Moderate-to-Severe COPD (PRIDE)

Conditions
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Pulmonary Disease, Chronic Obstructive, Airflow Obstruction, Chronic, Chronic Obstructive Airway Disease, Chronic Obstructive Lung Disease

Intervention / Treatment
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* Device: Noninvasive Open Ventilation System


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Noninvasive Open Ventilation System<br>Portable noninvasive open ventilator & nasal interface. | Device: Noninvasive Open Ventilation System<br>* Noninvasive ventilation system<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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). | Periodically over six hours x 5 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | At conclusion of subject's participation (up to two weeks) | 
| Safety and Device-related Adverse Events | Any adverse events reported during he study period. | Continuous from Study Day 2 through Study Day 6 |