Clinical trial NCT03349437: Vitabreath Pilot in Chronic Obstructive Pulmonary Disease (COPD) Patients
Official title: Pilot Study to Assess the Effect of Providing Intermittent Positive Airway Pressure in COPD Patients in Order to Relieve Their Exertion Related Shortness of Breath
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: COPD
Dyspnea
Lead sponsor: Philips Respironics
Sponsor class: INDUSTRY
First posted: 2017-11-21
Enrollment: 25
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Participants will receive two different interventions after exertion.
Primary purpose: TREATMENT

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 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.


Eligibility criteria: 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)

Primary outcomes:
measure: Average Distance During Modified 6 Minute Walk Test
timeFrame: 15 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Youngstown
country: United States
facility: Pullmonary Rehabilition Associates
state: Ohio
city: Jefferson Hills
country: United States
facility: Pittsburgh Pulmonary Associates
state: Pennsylvania
Study officials:
References: