Trials / Completed
CompletedNCT01355978
Non-invasive Ventilation System in Moderate-to-Severe Chronic Obstructive Pulmonary Disease (COPD)
Acceptability, Comfort, and Exercise Tolerance Using a Non-invasive Ventilation System in Patients With Moderate-to-Severe COPD (PRIDE)
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 22 (actual)
- Sponsor
- Breathe Technologies, Inc. · Industry
- Sex
- All
- Age
- 21 Years – 80 Years
- Healthy volunteers
- Not accepted
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.
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: 2. 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). 3. 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.
Conditions
- Pulmonary Disease, Chronic Obstructive
- Airflow Obstruction, Chronic
- Chronic Obstructive Airway Disease
- Chronic Obstructive Lung Disease
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Noninvasive Open Ventilation System | Noninvasive ventilation system |
Timeline
- Start date
- 2011-08-01
- Primary completion
- 2011-10-01
- Completion
- 2011-10-01
- First posted
- 2011-05-19
- Last updated
- 2016-10-12
- Results posted
- 2016-10-12
Locations
3 sites across 1 country: United States
Source: ClinicalTrials.gov record NCT01355978. Inclusion in this directory is not an endorsement.