N/A
N=22
Non-invasive Ventilation System in Moderate-to-Severe Chronic Obstructive Pulmonary Disease (COPD)
Pulmonary Disease, Chronic Obstructive · Airflow Obstruction, Chronic · Chronic Obstructive Airway Disease · Chronic Obstructive Lung Disease
Bottom Line
View on ClinicalTrials.gov: NCT01355978 ↗Enrolled (actual)
22
Serious AEs
0.0%
Results posted
Oct 2016
Primary outcome: Primary: Device Tidal Volume — 180 mL
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Noninvasive Open Ventilation System (Device)
- Age
- Adult, Older Adult · 21+ yrs
- Sex
- All
- Sponsor
- Breathe Technologies, Inc.
- Primary completion
- Oct 2011
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Device Tidal Volume |
180 | — |
| SECONDARY Device Preference |
4 | — |
| SECONDARY Safety and Device-related Adverse Events |
3 | — |
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.
Eligibility Criteria
Inclusion Criteria
- Have participated and completed the NOVEL 1 or NOVEL 2 studies.
- Be 21-80 years of age (inclusive) at time of informed consent.
- Require nasal oxygen of ≥ 2 LPM during exertion, and ≥ 1 LPM at rest.
- Exhibit dyspnea and have lung disease process dominated by COPD per the Study Investigator.
- Have a self-reported MMRC Dyspnea Score ≥ 2 on a scale of 0-4.
- Have spirometric evidence of COPD with an FEV1 of 8 LPM oxygen during exertion.
- Have a history of serious allergic airways disease (e.g., high eosinophil count or elevated IgE).
- Report or have evidence of LVEF 40
- Have a history of thoracotomy, sternotomy, major cardiopulmonary intervention (e.g., lung resection, open heart surgery), or any procedure 6 months before study entry likely to cause instability of pulmonary status.
- Have a history of lung disease unrelated to smoking that affects oxygenation or survival.
- Is participating in another intervention study or have participated within 90 days of enrollment.
- Have endobronchial valves or other bronchial tree implants such as stents.
- Have a disease or condition expected to cause death, inability to perform procedures for the trial, or inability to comply with the therapy.
- Have a history of intolerance to oxygen therapy.
Data sourced from ClinicalTrials.gov (NCT01355978). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.