Clinical trial NCT01355978: Non-invasive Ventilation System in Moderate-to-Severe Chronic Obstructive Pulmonary Disease (COPD)
Official title: Acceptability, Comfort, and Exercise Tolerance Using a Non-invasive Ventilation System in Patients With Moderate-to-Severe COPD (PRIDE)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pulmonary Disease, Chronic Obstructive
Airflow Obstruction, Chronic
Chronic Obstructive Airway Disease
Chronic Obstructive Lung Disease
Lead sponsor: Breathe Technologies, Inc.
Sponsor class: INDUSTRY
First posted: 2011-05-19
Enrollment: 22
Sex: ALL
Minimum age (years): 21
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

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.

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 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.

Primary outcomes:
measure: Device Tidal Volume
timeFrame: Periodically over six hours x 5 days
Secondary outcomes:
measure: Device Preference
timeFrame: At conclusion of subject's participation (up to two weeks)
measure: Safety and Device-related Adverse Events
timeFrame: Continuous from Study Day 2 through Study Day 6
Other outcomes:
Locations:
city: Concord
country: United States
facility: John Muir Health
state: California
city: San Diego
country: United States
facility: Sharp Memorial Hospital
state: California
city: Ogden
country: United States
facility: McKay-Dee Hospital Center
state: Utah
Study officials:
affiliation: John Muir Health
name: Richard Kops, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Sharp HealthCare
name: Lynn McCabe, RRT, RCP
role: PRINCIPAL_INVESTIGATOR
References: