Vitabreath Pilot in Chronic Obstructive Pulmonary Disease (COPD) Patients

NCT03349437 | Completed Results FDA Device

• 1 other identifier: HRC-17007-VBIDEPILOT-PN
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 2

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.

Conditions

COPD; Dyspnea

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Vitabreath Device

EXPERIMENTAL

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

Pursed Lip Breathing

ACTIVE COMPARATOR

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

Interventions

Vitabreath Device 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

Vitabreath Device

Pursed Lip Breathing OTHER

Pursed lip breathing (PLB) is the standard of care and will be used as the control condition comparator.

Pursed Lip Breathing

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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)

Sponsors & Collaborators

• Philips Respironics: lead

Study Sites (2)

Pullmonary Rehabilition Associates

Youngstown, Ohio, 44512, United States

Location

Pittsburgh Pulmonary Associates

Jefferson Hills, Pennsylvania, 15025, United States

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive; Dyspnea

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Respiration Disorders; Signs and Symptoms, Respiratory; Signs and Symptoms

Results Point of Contact

• Title: Biostatistician
• Organization: Philips

jeff.jasko@philips.com

412-542-3651

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Participants will receive two different interventions after exertion.

Study Record Dates

• First Submitted: November 17, 2017
• First Posted: November 21, 2017
• Study Start: November 6, 2017
• Primary Completion: February 20, 2018
• Study Completion: February 20, 2018
• Last Updated: May 8, 2019
• Results First Posted: April 16, 2019

Record last verified: 2019-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)