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

NCT01347931 | Completed Results

• 1 other identifier: CP-00-0034
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Pulmonary Disease, Chronic Obstructive; Airflow Obstruction, Chronic; Chronic Obstructive Airway Disease; Chronic Obstructive Lung Disease

Outcome Measures

Primary Outcomes (1)

• Activity Endurance Time

  Time in minutes of sustained activity while using test treatments

  Measured during single day study visit

Secondary Outcomes (2)

• Arterial Oxygen Saturation

  Measured during activity testing in a single day study visit

• Borg Dyspnea Score

  Measured during activity testing in a single day study visit

Study Arms (2)

NIOV System

EXPERIMENTAL

Noninvasive ventilation and oxygen delivered via NIOV System oxygen using an open nasal interface. Connected to standard portable oxygen cylinder

Device: NIOV System

Standard Oxygen Therapy

ACTIVE COMPARATOR

Supplemental oxygen using standard oxygen cannula connected to a portable oxygen cylinder.

Device: Standard Oxygen Cannula

Interventions

NIOV System DEVICE

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.

Also known as: NIOV, Oxygen, O2

NIOV System

Standard Oxygen Cannula DEVICE

Supplemental oxygen via a standard oxygen cannula connected to a portable oxygen cylinder

Also known as: Cannula

Standard Oxygen Therapy

Eligibility Criteria

• Age: 21 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Breathe Technologies, Inc.: lead

Study Sites (1)

Allegheny General Hospital

Pittsburgh, Pennsylvania, 15212, United States

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Interventions

Oxygen Inhalation Therapy; Cannula

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Respiratory Therapy; Therapeutics; Catheters; Equipment and Supplies

Results Point of Contact

• Title: Richard J. Morishige, MS, RRT
• Organization: Clinical Reseach Consulting

rjmorishige@gmail.com

510-606-0375

Study Officials

• Brian W Carlin, MD

  West Penn Allegheny Health System

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 3, 2011
• First Posted: May 5, 2011
• Study Start: May 1, 2011
• Primary Completion: March 1, 2012
• Study Completion: March 1, 2012
• Last Updated: October 11, 2016
• Results First Posted: October 11, 2016

Record last verified: 2016-08

Locations

US (1)