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

Pulmonary Disease, Chronic Obstructive Clinical Trial

Official title:

In-home Evaluation of the Breathe Technologies Noninvasive Open Ventilation (NIOV™) System in Patients With Severe Respiratory Insufficiency

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01347931
• Other study ID #: CP-00-0034
• Status: Completed
• Phase: N/A
• First received: May 3, 2011
• Last updated: April 20, 2012
• Start date: May 2011
• Est. completion date: March 2012

Study information

• Verified date: April 2012
• Source: Breathe Technologies, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: March 2012
• Est. primary completion date: March 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 21 Years to 80 Years

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Airflow Obstruction, Chronic
• Chronic Disease
• Chronic Obstructive Airway Disease
• Chronic Obstructive Lung Disease
• Lung Diseases
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive
• Pulmonary Valve Insufficiency
• Respiratory Insufficiency

Intervention

Device:
• Breathe NIOV System
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.

Locations

Country	Name	City	State
United States	Allegheny General Hospital	Pittsburgh	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Breathe Technologies, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Dyspnea Score	Borg Dyspnea Score (BDS)	Periodically over four hours	No
Primary	Fatigue Score	Fatigue Visual Analogue Scale (VAS)	Periodically over four hours	No
Primary	Comfort Score	Comfort Visual Analog Scale (VAS)	Periodically over four hours	No
Secondary	Heart rate		Up to four hours each study visit	No
Secondary	Respiratory rate		Up to four hours each study visit	No
Secondary	Oxygen saturation	Pulse oximetry	Up to four hours each study visit	No
Secondary	Partial pressure of carbon dioxide measured transcutaneously (TcPCO2)		Periodically over four hours	No
Secondary	Actigraphy	Actigraphy monitor	Up to four hours each study visit	No
Secondary	Quality of Life (QOL)	Chronic Respiratory Questionnaire	Before intervention begins on the first study day (baseline); at the completion of the first study day; at the completion of study days 2-9.	No