- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01355978
Non-invasive Ventilation System in Moderate-to-Severe Chronic Obstructive Pulmonary Disease (COPD) (PRIDE)
Acceptability, Comfort, and Exercise Tolerance Using a Non-invasive Ventilation System in Patients With Moderate-to-Severe COPD (PRIDE)
Study Overview
Status
Conditions
Intervention / Treatment
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:
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
California
-
Concord, California, United States, 94520
- John Muir Health
-
San Diego, California, United States, 92123
- Sharp Memorial Hospital
-
-
Utah
-
Ogden, Utah, United States, 84403
- McKay-Dee Hospital Center
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Noninvasive Open Ventilation System
Portable noninvasive open ventilator & nasal interface.
|
Noninvasive ventilation system
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Device Tidal Volume
Time Frame: 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).
|
Periodically over six hours x 5 days
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Device Preference
Time Frame: 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) |
At conclusion of subject's participation (up to two weeks)
|
Safety and Device-related Adverse Events
Time Frame: Continuous from Study Day 2 through Study Day 6
|
Any adverse events reported during he study period.
|
Continuous from Study Day 2 through Study Day 6
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Richard Kops, MD, John Muir Health
- Principal Investigator: Lynn McCabe, RRT, RCP, Sharp HealthCare
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CP-00-0031
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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