Vitabreath Pilot in Chronic Obstructive Pulmonary Disease (COPD) Patients
Vitabreath Pilot in Chronic Obstructive Pulmonary Disease (COPD) Patients
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 Ventilation (NIV) during exercise to increase tolerance overall, there
 is little research specifically looking at shortening dyspnea recovery times associated with
 exercise. We hypothesize that providing intermittent non-invasive positive pressure therapy
 (a form of NIV or PAP) with a handheld device to COPD patients immediately after exertion can
 relieve their dyspnea, and consequently allow them to be more active. In this study, we are
 comparing the distance walked as measured by a modified 6-Minute Walk Test (6MWT) of 20 COPD
 patients using VitaBreath (NIV) device versus Pursed Lip Breathing.
Inclusion Criteria:

 -  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 Criteria:

 -  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)