Status:
COMPLETED
Vitabreath Pilot in Chronic Obstructive Pulmonary Disease (COPD) Patients
Lead Sponsor:
Philips Respironics
Conditions:
COPD
Dyspnea
Eligibility:
All Genders
40+ years
Phase:
NA
Brief Summary
Dyspnea is the most common symptom limiting the ability of COPD patients to perform activities of daily living. Although there has been research involving the benefit of providing Non Invasive Ventila...
Eligibility Criteria
Inclusion
- Age ≥ 40
- Ability to provide consent
- COPD diagnosis
- Forced Expiratory Volume in one second (FEV1) \<55 and ≥ 25 percent of predicted value
- Perceived Shortness of Breath via the Modified Medical Research Counsel Dyspnea questionnaire (rating of 2 or greater) (Appendix B)
- Able to follow directions
- Able to tolerate mild physical activity
- Pursed Lip Breathing as standard of care
- No evidence of bullous lung disease (with any bullae greater than 3cm in diameter) as confirmed by a CT scan within the past one year.
Exclusion
- Subjects who are acutely ill, medically complicated or who are medically unstable as determined by the investigator.
- Suffering from COPD exacerbation at time of enrollment or 60 days prior
- Subjects who are not currently prescribed oxygen and manifest oxygen desaturation below 88% on the screening 6MWT
- Subjects with heart disease or neuromuscular disease.
- Subjects who are not prescribed short-acting bronchodilator medication
- Patients who have experienced recent barotrauma or pneumothorax
- Unstable angina or Myocardial Infarction during past month
- Uncontrolled Hypertension (systolic blood pressure of \>180mmHg (millimeters of Mercury) and a diastolic \>100mmHg)
- Heart Rate \>120 at rest
- Subjects who have trouble coordinating their breathing with the device during the device training, or cannot tolerate the device mouthpiece resulting in leaks from the nasal cavity
- Women of child-bearing potential (WOCP) who are pregnant, breast-feeding, or planning pregnancy during the course of the study. (WOCP must have a negative pregnancy test at every visit)
Key Trial Info
Start Date :
November 6 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 20 2018
Estimated Enrollment :
25 Patients enrolled
Trial Details
Trial ID
NCT03349437
Start Date
November 6 2017
End Date
February 20 2018
Last Update
May 8 2019
Active Locations (2)
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1
Pullmonary Rehabilition Associates
Youngstown, Ohio, United States, 44512
2
Pittsburgh Pulmonary Associates
Jefferson Hills, Pennsylvania, United States, 15025