In-home Evaluation of a Noninvasive Open Ventilation System in Patients With Severe Respiratory Insufficiency

• Sponsor: Breathe Technologies, Inc. (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01347931
• Collaborator: (none)
• Enrollment: 30
• Location: 1
• Arms: 2
• Duration (Months): 10
• Patients Per Site Per Month: 3

Study Details

Study Description

Brief Summary

The Breathe NIOV™ System will reduce the work of breathing in subjects with chronic respiratory insufficiency who require long-term oxygen therapy (LTOT). The Breathe system will accomplish this by providing oxygen under pressure and augmenting the subject's spontaneous tidal volumes. The combination of efficient oxygen delivery, assisted ventilation, and a comfortable low-profile device, will result in a mean improvement in perceived well-being and ability to perform ADLs, as measured by patient-reported outcome (PRO) instruments.

Condition or Disease	Intervention/Treatment	Phase
Pulmonary Disease, Chronic Obstructive; Airflow Obstruction, Chronic; Chronic Obstructive Airway Disease; Chronic Obstructive Lung Disease	Device: NIOV System; Device: Standard Oxygen Cannula	N/A

Detailed Description

This will be a prospective, open-label, crossover study in up to 12 stable subjects with chronic respiratory insufficiency who require LTOT. Each subject's standard oxygen therapy will be used as the control treatment and compared to the test ventilator system during selected activities of daily living. Subjects will participate in the study for up to 9 home visits, with Visits 1 and 2 each lasting for approximately 4 hours, and Visits 3-9 lasting approximately 1-2 hours each. Subjects may discontinue study participation at any time.

Study Design

• Study Type: Interventional
• Actual Enrollment: 30 participants
• Allocation: Non-Randomized
• Intervention Model: Crossover Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: In-home Evaluation of the Breathe Technologies Noninvasive Open Ventilation (NIOV™) System in Patients With Severe Respiratory Insufficiency
• Study Start Date: May 1, 2011
• Actual Primary Completion Date: Mar 1, 2012
• Actual Study Completion Date: Mar 1, 2012

Arms and Interventions

Arm	Intervention/Treatment
Experimental: NIOV System Noninvasive ventilation and oxygen delivered via NIOV System oxygen using an open nasal interface. Connected to standard portable oxygen cylinder	Device: NIOV System; Each subject's standard oxygen therapy will be used as the control treatment and compared to the test ventilator (NIOV) system during selected activities of daily living.; Other Names: NIOV Oxygen O2
Active Comparator: Standard Oxygen Therapy Supplemental oxygen using standard oxygen cannula connected to a portable oxygen cylinder.	Device: Standard Oxygen Cannula; Supplemental oxygen via a standard oxygen cannula connected to a portable oxygen cylinder; Other Names: Cannula

Outcome Measures

Primary Outcome Measures

1. Activity Endurance Time [Measured during single day study visit]

   Time in minutes of sustained activity while using test treatments

Secondary Outcome Measures

1. Arterial Oxygen Saturation [Measured during activity testing in a single day study visit]

   O2 saturation measured by pulse oximetry

2. Borg Dyspnea Score [Measured during activity testing in a single day study visit]

   Borg Dyspnea score is measured using a 11-point visual analog scale. The lower the score on the scale, the less breathlessness patient experiences. The score ranges from: 0 = No breathlessness at all, representing better outcome 10 = Maximum, representing worse outcome

Eligibility Criteria

Criteria

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

Inclusion Criteria:

• Adult male and female subjects, 21-80 years of age

• Diagnosis of chronic respiratory insufficiency including COPD and interstitial lung disease

• Requires use of continuous nasal oxygen of at least 2 lpm

• Reports limitation of activity due to fatigue or breathlessness

• Fluent in written and spoken English language

• Ability to be properly fitted with the Breathe nasal mask

• Ability to tolerate and be appropriately titrated on the Breathe ventilator

• Ability to communicate self-assessment of dyspnea, comfort, and fatigue

• Ability and willingness to participate in the study including walking and other activities of daily living

• Ability to provide written informed consent

Exclusion Criteria:

• Recent history of frequent or severe epistaxis

• Symptoms of acute respiratory exacerbation within 48 hours of Study Day 1

• Discharge from the hospital within 30 days of study enrollment

• Subjects, who in the opinion of the Investigator, are not suitable candidates for enrollment or who are unlikely to be able to comply with trial requirements

• Subjects with conditions that, in the Investigator's opinion, contraindicates study participation

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Allegheny General Hospital	Pittsburgh	Pennsylvania	United States	15212

Sponsors and Collaborators

• Breathe Technologies, Inc.

Investigators

• Principal Investigator: Brian W Carlin, MD, West Penn Allegheny Health System

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Breathe Technologies, Inc.
• ClinicalTrials.gov Identifier: NCT01347931
• Other Study ID Numbers: CP-00-0034
• First Posted: May 5, 2011
• Last Update Posted: Oct 11, 2016
• Last Verified: Aug 1, 2016

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

Study Results

Participant Flow

Arm/Group Title	Standard Oxygen Therapy
Arm/Group Description	Supplemental oxygen delivered via standard nasal cannula connected to a portable oxygen cylinder. Breathe NIOV System: Each subject's standard oxygen therapy will be used as the control treatment and compared to the test ventilator (NIOV) system during selected activities of daily living.
Period Title: Standard Oxygen Therapy
STARTED	30
COMPLETED	29
NOT COMPLETED	1
Period Title: Standard Oxygen Therapy
STARTED	29
COMPLETED	29
NOT COMPLETED	0

Baseline Characteristics

Arm/Group Title	Overall Study Group
Arm/Group Description	All subjects participating in 2-way crossover design study
Overall Participants	30
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	72 (6.3)
Sex: Female, Male (Count of Participants)
Female	18 60%
Male	12 40%
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	4 13.3%
White	26 86.7%
More than one race	0 0%
Unknown or Not Reported	0 0%
Region of Enrollment (participants) [Number]
United States	30 100%

Outcome Measures

1. Primary Outcome

Title	Activity Endurance Time
Description	Time in minutes of sustained activity while using test treatments
Time Frame	Measured during single day study visit

Outcome Measure Data

Analysis Population Description

Per Protocol

Arm/Group Title	Standard Oxygen Therapy	Breathe NIOV System
Arm/Group Description	Supplemental oxygen delivered via standard nasal cannula connected to a portable oxygen cylinder. NIOV System: Each subject's standard oxygen therapy will be used as the control treatment and compared to the test ventilator (NIOV) system during selected activities of daily living.	Noninvasive ventilation delivered via NIOV System oxygen using an open nasal interface. Connected to standard portable oxygen cylinder NIOV System: Each subject's standard oxygen therapy will be used as the control treatment and compared to the test ventilator (NIOV) system during selected activities of daily living.
Measure Participants	29	29
Mean (Standard Deviation) [minutes]	7.24 (5.21)	13.38 (7.50)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Standard Oxygen Therapy, Breathe NIOV System
	Comments	A sample size of 26 patient pairs was determined based on the assumption of a true treatment difference in mean ADL endurance time of 4 ± 7 minutes using a two-tailed, paired t test (α=0.05, power=0.80).
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.05
	Comments
	Method	t-test, 2 sided
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	4
	Confidence Interval	(2-Sided) 95%; 2 to 10
	Parameter Dispersion	Type: Standard Deviation; Value: 7
	Estimation Comments

2. Secondary Outcome

Title	Arterial Oxygen Saturation
Description	O2 saturation measured by pulse oximetry
Time Frame	Measured during activity testing in a single day study visit

Outcome Measure Data

Analysis Population Description

Per Protocol

Arm/Group Title	Standard Oxygen Therapy	Breathe NIOV System
Arm/Group Description	Supplemental oxygen delivered via standard nasal cannula connected to a portable oxygen cylinder. NIOV System: Each subject's standard oxygen therapy will be used as the control treatment and compared to the test ventilator (NIOV) system during selected activities of daily living.	Noninvasive ventilation delivered via NIOV System oxygen using an open nasal interface. Connected to standard portable oxygen cylinder NIOV System: Each subject's standard oxygen therapy will be used as the control treatment and compared to the test ventilator (NIOV) system during selected activities of daily living.
Measure Participants	29	29
Mean (Standard Deviation) [percentage of oxyHb saturation]	90.65 (4.87)	94.78 (1.99)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Standard Oxygen Therapy, Breathe NIOV System
	Comments	Two-tailed t test
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.05
	Comments
	Method	t-test, 2 sided
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	3
	Confidence Interval	(2-Sided) 95%; 1 to 7
	Parameter Dispersion	Type: Standard Deviation; Value: 4
	Estimation Comments

3. Secondary Outcome

Title	Borg Dyspnea Score
Description	Borg Dyspnea score is measured using a 11-point visual analog scale. The lower the score on the scale, the less breathlessness patient experiences. The score ranges from: 0 = No breathlessness at all, representing better outcome 10 = Maximum, representing worse outcome
Time Frame	Measured during activity testing in a single day study visit

Outcome Measure Data

Analysis Population Description

Per Protocol

Arm/Group Title	Standard Oxygen Therapy	Breathe NIOV System
Arm/Group Description	Supplemental oxygen delivered via standard nasal cannula connected to a portable oxygen cylinder. NIOV System: Each subject's standard oxygen therapy will be used as the control treatment and compared to the test ventilator (NIOV) system during selected activities of daily living.	Noninvasive ventilation delivered via NIOV System oxygen using an open nasal interface. Connected to standard portable oxygen cylinder NIOV System: Each subject's standard oxygen therapy will be used as the control treatment and compared to the test ventilator (NIOV) system during selected activities of daily living.
Measure Participants	29	29
Median (95% Confidence Interval) [units on a scale]	3	1

Adverse Events

Time Frame	Continuously monitored during a Single day study visit lasting up to 4 hours
Arm/Group Title	Standard Oxygen Therapy		Breathe NIOV System
Arm/Group Description	Supplemental oxygen delivered via standard nasal cannula connected to a portable oxygen cylinder. NIOV System: Each subject's standard oxygen therapy will be used as the control treatment and compared to the test ventilator (NIOV) system during selected activities of daily living.		Noninvasive ventilation delivered via NIOV System oxygen using an open nasal interface. Connected to standard portable oxygen cylinder NIOV System: Each subject's standard oxygen therapy will be used as the control treatment and compared to the test ventilator (NIOV) system during selected activities of daily living.
All Cause Mortality
	Standard Oxygen Therapy		Breathe NIOV System
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Standard Oxygen Therapy		Breathe NIOV System
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/29 (0%)		0/29 (0%)
Other (Not Including Serious) Adverse Events
	Standard Oxygen Therapy		Breathe NIOV System
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/29 (0%)		0/29 (0%)

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.