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

This is an interventional supportive care trial for Pulmonary Disease, Chronic Obstructive Read More

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.