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

• Sponsor: Breathe Technologies, Inc. (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01355978
• Collaborator: (none)
• Enrollment: 22
• Locations: 3
• Arm: 1
• Duration (Months): 2
• Patients Per Site: 7.3
• Patients Per Site Per Month: 3.7

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Pulmonary Disease, Chronic Obstructive; Airflow Obstruction, Chronic; Chronic Obstructive Airway Disease; Chronic Obstructive Lung Disease	Device: Noninvasive Open Ventilation System	N/A

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:

1. 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).

2. 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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 22 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (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)
• Study Start Date: Aug 1, 2011
• Actual Primary Completion Date: Oct 1, 2011
• Actual Study Completion Date: Oct 1, 2011

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Noninvasive Open Ventilation System Portable noninvasive open ventilator & nasal interface.	Device: Noninvasive Open Ventilation System; Noninvasive ventilation system

Outcome Measures

Primary Outcome Measures

1. Device Tidal Volume [Periodically over six hours x 5 days]

   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).

Secondary Outcome Measures

1. Device Preference [At conclusion of subject's participation (up to two weeks)]

   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)

2. Safety and Device-related Adverse Events [Continuous from Study Day 2 through Study Day 6]

   Any adverse events reported during he study period.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 21 Years to 80 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Locations

	Site	City	State	Country	Postal Code
1	John Muir Health	Concord	California	United States	94520
2	Sharp Memorial Hospital	San Diego	California	United States	92123
3	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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Breathe Technologies, Inc.
• ClinicalTrials.gov Identifier: NCT01355978
• Other Study ID Numbers: CP-00-0031
• First Posted: May 19, 2011
• Last Update Posted: Oct 12, 2016
• Last Verified: Aug 1, 2016

• Additional relevant MeSH terms: Lung Diseases; Pulmonary Disease, Chronic Obstructive; Lung Diseases, Obstructive

Study Results

Participant Flow

Arm/Group Title	Noninvasive Open Ventilation System
Arm/Group Description	Portable noninvasive open ventilator & nasal interface. Noninvasive Open Ventilation System: Noninvasive ventilation system
Period Title: Overall Study
STARTED	22
COMPLETED	18
NOT COMPLETED	4

Baseline Characteristics

Arm/Group Title	Noninvasive Open Ventilation System
Arm/Group Description	Portable noninvasive open ventilator & nasal interface. Noninvasive Open Ventilation System used during activities of daily living.
Overall Participants	18
Age (Count of Participants)
<=18 years	0 0%
Between 18 and 65 years	5 27.8%
>=65 years	13 72.2%
Sex: Female, Male (Count of Participants)
Female	9 50%
Male	9 50%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%
Asian	0 0%
Native Hawaiian or Other Pacific Islander	0 0%
Black or African American	0 0%
White	18 100%
More than one race	0 0%
Unknown or Not Reported	0 0%
Region of Enrollment (participants) [Number]
United States	18 100%

Outcome Measures

1. Primary Outcome

Title	Device Tidal Volume
Description	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).
Time Frame	Periodically over six hours x 5 days

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Noninvasive Open Ventilation System
Arm/Group Description	Portable noninvasive open ventilator & nasal interface. Noninvasive Open Ventilation System: Noninvasive ventilation system
Measure Participants	18
Mean (Standard Deviation) [mL]	180 (24)

2. Secondary Outcome

Title	Device Preference
Description	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)
Time Frame	At conclusion of subject's participation (up to two weeks)

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Noninvasive Open Ventilation System
Arm/Group Description	Portable noninvasive open ventilator & nasal interface. Noninvasive Open Ventilation System: Noninvasive ventilation system
Measure Participants	18
Median (Full Range) [units on a scale]	4

3. Secondary Outcome

Title	Safety and Device-related Adverse Events
Description	Any adverse events reported during he study period.
Time Frame	Continuous from Study Day 2 through Study Day 6

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Noninvasive Open Ventilation System
Arm/Group Description	Portable noninvasive open ventilator & nasal interface. Noninvasive Open Ventilation System: Noninvasive ventilation system
Measure Participants	18
Number [participants]	3 16.7%

Adverse Events

Time Frame	Continuously for 1 week, starting a screening visit through end of study (Day 6).
Arm/Group Title	Noninvasive Open Ventilation System
Arm/Group Description	Portable noninvasive open ventilator & nasal interface. Noninvasive Open Ventilation System: Noninvasive ventilation system
All Cause Mortality
	Noninvasive Open Ventilation System
	Affected / at Risk (%)	# Events
Total	/ (NaN)
Serious Adverse Events
	Noninvasive Open Ventilation System
	Affected / at Risk (%)	# Events
Total	0/18 (0%)
Other (Not Including Serious) Adverse Events
	Noninvasive Open Ventilation System
	Affected / at Risk (%)	# Events
Total	3/18 (16.7%)
Respiratory, thoracic and mediastinal disorders
Shortness of breath	1/18 (5.6%)	18
Shortness of breath	1/18 (5.6%)	18
Skin and subcutaneous tissue disorders
Rash	1/18 (5.6%)	1

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.