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: February 4, 2013
Last verified: February 2013
  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: Breathe Technologies Noninvasive Open Ventilation (NIOV™) 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:
  • Dyspnea Score [ Time Frame: Periodically over six hours ] [ Designated as safety issue: No ]
    Borg Dyspnea Score


Secondary Outcome Measures:
  • Quality of Life [ Time Frame: At baseline and at conclusion of subject's participation (up to two weeks) ] [ Designated as safety issue: No ]
    Chronic Respiratory Questionnaire

  • Actigraphy [ Time Frame: Continuously measured from Study Day 2 through Study Day 6 ] [ Designated as safety issue: No ]

Enrollment: 20
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: Single Arm - NIOV Ventilator Device: Breathe Technologies Noninvasive Open Ventilation (NIOV™) System
Subjects will report their tolerance and comfort while using the test ventilation system, while exercising, doing activities of daily living, and while resting. Subjects will use the test ventilation system for 6 hours a day for 5 days.

  Eligibility

Ages Eligible for Study:   21 Years to 80 Years
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
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

No publications provided

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
Last Updated: February 4, 2013
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on April 16, 2014