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

Pulmonary Disease, Chronic Obstructive Clinical Trial

— PRIDE  

Official title:

Acceptability, Comfort, and Exercise Tolerance Using a Non-invasive Ventilation System in Patients With Moderate-to-Severe COPD (PRIDE)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01355978
• Other study ID #: CP-00-0031
• Status: Completed
• Phase: N/A
• First received: May 17, 2011
• Last updated: February 4, 2013
• Start date: August 2011
• Est. completion date: October 2011

Study information

• Verified date: February 2013
• Source: Breathe Technologies, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: October 2011
• Est. primary completion date: October 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 21 Years to 80 Years

Eligibility

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 Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Airflow Obstruction, Chronic
• Chronic Disease
• Chronic Obstructive Airway Disease
• Chronic Obstructive Lung Disease
• Lung Diseases
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive

Intervention

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.

Locations

Country	Name	City	State
United States	John Muir Health	Concord	California
United States	McKay-Dee Hospital Center	Ogden	Utah
United States	Sharp Memorial Hospital	San Diego	California

Sponsors (1)

Lead Sponsor	Collaborator
Breathe Technologies, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Dyspnea Score	Borg Dyspnea Score	Periodically over six hours	No
Secondary	Quality of Life	Chronic Respiratory Questionnaire	At baseline and at conclusion of subject's participation (up to two weeks)	No
Secondary	Actigraphy		Continuously measured from Study Day 2 through Study Day 6	No