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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Breathe Technologies, Inc.
ClinicalTrials.gov Identifier:
NCT01355978
First received: May 17, 2011
Last updated: August 18, 2016
Last verified: August 2016
  Purpose
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.

Condition Intervention
Pulmonary Disease, Chronic Obstructive
Airflow Obstruction, Chronic
Chronic Obstructive Airway Disease
Chronic Obstructive Lung Disease
Device: Noninvasive Open Ventilation System

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: Acceptability, Comfort, and Exercise Tolerance Using a Non-invasive Ventilation System in Patients With Moderate-to-Severe COPD (PRIDE)

Resource links provided by NLM:


Further study details as provided by Breathe Technologies, Inc.:

Primary Outcome Measures:
  • Device Tidal Volume [ Time Frame: Periodically over six hours x 5 days ] [ Designated as safety issue: No ]
    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 Outcome Measures:
  • Device Preference [ Time Frame: At conclusion of subject's participation (up to two weeks) ] [ Designated as safety issue: No ]

    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 [ Time Frame: Continuous from Study Day 2 through Study Day 6 ] [ Designated as safety issue: Yes ]
    Any adverse events reported during he study period.


Enrollment: 22
Study Start Date: August 2011
Study Completion Date: October 2011
Primary Completion Date: October 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Noninvasive Open Ventilation System
Portable noninvasive open ventilator & nasal interface.
Device: Noninvasive Open Ventilation System
Noninvasive ventilation system

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.
  Eligibility

Ages Eligible for Study:   21 Years to 80 Years   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01355978

Locations
United States, California
John Muir Health
Concord, California, United States, 94520
Sharp Memorial Hospital
San Diego, California, United States, 92123
United States, Utah
McKay-Dee Hospital Center
Ogden, Utah, United States, 84403
Sponsors and Collaborators
Breathe Technologies, Inc.
Investigators
Principal Investigator: Richard Kops, MD John Muir Health
Principal Investigator: Lynn McCabe, RRT, RCP Sharp HealthCare
  More Information

Responsible Party: Breathe Technologies, Inc.
ClinicalTrials.gov Identifier: NCT01355978     History of Changes
Other Study ID Numbers: CP-00-0031 
Study First Received: May 17, 2011
Results First Received: March 7, 2015
Last Updated: August 18, 2016
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Lung Diseases
Pulmonary Disease, Chronic Obstructive
Chronic Disease
Lung Diseases, Obstructive
Respiratory Tract Diseases
Disease Attributes
Pathologic Processes

ClinicalTrials.gov processed this record on December 02, 2016