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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Breathe Technologies, Inc.
ClinicalTrials.gov Identifier:
NCT01347931
First received: May 3, 2011
Last updated: August 17, 2016
Last verified: August 2016
  Purpose
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 Intervention
Pulmonary Disease, Chronic Obstructive
Airflow Obstruction, Chronic
Chronic Obstructive Airway Disease
Chronic Obstructive Lung Disease
Device: NIOV System
Device: Standard Oxygen Cannula

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Breathe Technologies, Inc.:

Primary Outcome Measures:
  • Activity Endurance Time [ Time Frame: Measured during single day study visit ] [ Designated as safety issue: No ]
    Time in minutes of sustained activity while using test treatments


Secondary Outcome Measures:
  • Arterial Oxygen Saturation [ Time Frame: Measured during activity testing in a single day study visit ] [ Designated as safety issue: No ]
    O2 saturation measured by pulse oximetry

  • Borg Dyspnea Score [ Time Frame: Measured during activity testing in a single day study visit ] [ Designated as safety issue: No ]

    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



Enrollment: 30
Study Start Date: May 2011
Study Completion Date: March 2012
Primary Completion Date: March 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: Cannula

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.
  Eligibility

Ages Eligible for Study:   21 Years to 80 Years   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01347931

Locations
United States, Pennsylvania
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
  More Information

Responsible Party: Breathe Technologies, Inc.
ClinicalTrials.gov Identifier: NCT01347931     History of Changes
Other Study ID Numbers: CP-00-0034 
Study First Received: May 3, 2011
Results First Received: March 8, 2015
Last Updated: August 17, 2016
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Lung Diseases
Chronic Disease
Pulmonary Disease, Chronic Obstructive
Respiratory Insufficiency
Pulmonary Valve Insufficiency
Lung Diseases, Obstructive
Respiratory Tract Diseases
Disease Attributes
Pathologic Processes
Respiration Disorders
Heart Valve Diseases
Heart Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on December 07, 2016