Vitabreath Pilot in Chronic Obstructive Pulmonary Disease (COPD) Patients

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

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.

Study Overview

• Status: Completed
• Conditions: COPD; Dyspnea
• Intervention / Treatment: Device: Vitabreath Device; Other: Pursed Lip Breathing

• Study Type: Interventional
• Enrollment (Actual): 25
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Ohio
    • Youngstown, Ohio, United States, 44512
      • Pullmonary Rehabilition Associates
  • Pennsylvania
    • Jefferson Hills, Pennsylvania, United States, 15025
      • Pittsburgh Pulmonary Associates

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: CROSSOVER
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Vitabreath Device; The Philips Respironics investigational device VitaBreath is a handheld, battery powered, intermittent positive airway pressure device that is non-invasive, and provides positive airway pressure (PAP) of 18 cm water (H2O) during inspiration and 8 cm H2O on expiration, thus creating 10 cm H2O of pressure support. Pressure support is defined as the difference between inhalation pressure and exhalation pressure. The study device is intended as an adjunct therapy to relieve shortness of breath in COPD patients who experience exertion-related dyspnea to allow them to be more active. The air is delivered to the patient via a mouthpiece on the device.	Device: Vitabreath Device; The VitaBreath device is designed for non-continuous use only and typical device use is expected to be for 2-3 minutes. The device should only be operated for less than 10 minutes at a time. After such time, the device should be turned off for at least 30 minutes
Active Comparator: Pursed Lip Breathing; Pursed lip breathing is a commonly used technique by COPD patients. That involves exhaling through tightly pressed lips and inhaling through the nose with the mouth closed.	Other: Pursed Lip Breathing; Pursed lip breathing (PLB) is the standard of care and will be used as the control condition comparator.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Average Distance During Modified 6 Minute Walk Test	Compare the average distance walked during modified 6 minute walk test (M 6MWT) by COPD participants using Pursed Lip Breathing (PLB) versus an intermittent positive airway pressure handheld device, VitaBreath.	15 minutes

Collaborators and Investigators

• Sponsor: Philips Respironics

Study record dates

Study Major Dates

• Study Start (Actual): November 6, 2017
• Primary Completion (Actual): February 20, 2018
• Study Completion (Actual): February 20, 2018

Study Registration Dates

• First Submitted: November 17, 2017
• First Submitted That Met QC Criteria: November 20, 2017
• First Posted (Actual): November 21, 2017

Study Record Updates

• Last Update Posted (Actual): May 8, 2019
• Last Update Submitted That Met QC Criteria: April 23, 2019
• Last Verified: April 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Respiration Disorders; Signs and Symptoms, Respiratory; Dyspnea
• Other Study ID Numbers: HRC-17007-VBIDEPILOT-PN

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes