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

NCT01355978 | Completed Results

• 1 other identifier: CP-00-0031
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 3

Brief Summary

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.

Conditions

Pulmonary Disease, Chronic Obstructive; Airflow Obstruction, Chronic; Chronic Obstructive Airway Disease; Chronic Obstructive Lung Disease

Outcome Measures

Primary Outcomes (1)

• Device Tidal Volume

  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 Outcomes (2)

• Device Preference

  At conclusion of subject's participation (up to two weeks)

• Safety and Device-related Adverse Events

  Continuous from Study Day 2 through Study Day 6

Study Arms (1)

Noninvasive Open Ventilation System

EXPERIMENTAL

Portable noninvasive open ventilator \& nasal interface.

Device: Noninvasive Open Ventilation System

Interventions

Noninvasive Open Ventilation System DEVICE

Noninvasive ventilation system

Noninvasive Open Ventilation System

Eligibility Criteria

• Age: 21 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Breathe Technologies, Inc.: lead

Study Sites (3)

John Muir Health

Concord, California, 94520, United States

Location

Sharp Memorial Hospital

San Diego, California, 92123, United States

Location

McKay-Dee Hospital Center

Ogden, Utah, 84403, United States

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Richard J. Morishige, MS, RRT
• Organization: Clinical Research Consuting

rjmorishige@gmail.com

510-606-0374

Study Officials

• Richard Kops, MD

  John Muir Health

  PRINCIPAL INVESTIGATOR

• Lynn McCabe, RRT, RCP

  Sharp HealthCare

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 17, 2011
• First Posted: May 19, 2011
• Study Start: August 1, 2011
• Primary Completion: October 1, 2011
• Study Completion: October 1, 2011
• Last Updated: October 12, 2016
• Results First Posted: October 12, 2016

Record last verified: 2016-08

Locations

US (3)