Now Available: Final Rule for FDAAA 801 and NIH Policy on Clinical Trial Reporting

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

May 17, 2011
August 18, 2016
August 2011
October 2011   (final data collection date for primary outcome measure)
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).
  • Comfort Score [ Time Frame: Periodically over six hours ] [ Designated as safety issue: No ]
    Comfort Visual Analog Scale
  • Dyspnea Score [ Time Frame: Periodically over six hours ] [ Designated as safety issue: No ]
    Borg Dyspnea Score
Complete list of historical versions of study NCT01355978 on ClinicalTrials.gov Archive Site
  • 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.
  • Quality of Life [ Time Frame: At basline 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 1 through Study Day 7 ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Non-invasive Ventilation System in Moderate-to-Severe Chronic Obstructive Pulmonary Disease (COPD)
Acceptability, Comfort, and Exercise Tolerance Using a Non-invasive Ventilation System in Patients With Moderate-to-Severe COPD (PRIDE)
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.

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.
Interventional
Not Provided
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Supportive Care
  • Pulmonary Disease, Chronic Obstructive
  • Airflow Obstruction, Chronic
  • Chronic Obstructive Airway Disease
  • Chronic Obstructive Lung Disease
Device: Noninvasive Open Ventilation System
Noninvasive ventilation system
Experimental: Noninvasive Open Ventilation System
Portable noninvasive open ventilator & nasal interface.
Intervention: Device: Noninvasive Open Ventilation System
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
22
October 2011
October 2011   (final data collection date for primary outcome measure)

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.
Both
21 Years to 80 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01355978
CP-00-0031
No
Not Provided
Not Provided
Breathe Technologies, Inc.
Breathe Technologies, Inc.
Not Provided
Principal Investigator: Richard Kops, MD John Muir Health
Principal Investigator: Lynn McCabe, RRT, RCP Sharp HealthCare
Breathe Technologies, Inc.
August 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP