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Vitabreath Pilot in Chronic Obstructive Pulmonary Disease (COPD) Patients

Primary Purpose

COPD, Dyspnea

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Vitabreath Device

Pursed Lip Breathing

About this trial

This is an interventional treatment trial for COPD

Eligibility Criteria

40 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

Pullmonary Rehabilition Associates
Pittsburgh Pulmonary Associates

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Vitabreath Device

Pursed Lip Breathing

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

NCT ID

NCT03349437

First Posted

November 17, 2017

Last Updated

April 23, 2019

Sponsor

Philips Respironics

1. Study Identification

Unique Protocol Identification Number

NCT03349437

Brief Title

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

2. Study Status

Record Verification Date

April 2019

Overall Recruitment Status

Completed

Study Start Date

November 6, 2017 (Actual)

Primary Completion Date

February 20, 2018 (Actual)

Study Completion Date

February 20, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Philips Respironics

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Yes

Device Product Not Approved or Cleared by U.S. FDA

Yes

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

COPD, Dyspnea

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Crossover Assignment

Model Description

Participants will receive two different interventions after exertion.

Masking

None (Open Label)

Allocation

Randomized

Enrollment

25 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Vitabreath Device

Arm Type

Experimental

Arm Description

Arm Title

Pursed Lip Breathing

Arm Type

Active Comparator

Arm Description

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.

Intervention Type

Device

Intervention Name(s)

Vitabreath Device

Intervention Description

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

Intervention Type

Other

Intervention Name(s)

Pursed Lip Breathing

Intervention Description

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

Primary Outcome Measure Information:

Title

Average Distance During Modified 6 Minute Walk Test

Description

Time Frame

15 minutes

10. Eligibility

Sex

All

Minimum Age & Unit of Time

40 Years

Accepts Healthy Volunteers

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)

Facility Information:

Facility Name

Pullmonary Rehabilition Associates

City

Youngstown

State/Province

Ohio

ZIP/Postal Code

44512

Country

United States

Facility Name

Pittsburgh Pulmonary Associates

City

Jefferson Hills

State/Province

Pennsylvania

ZIP/Postal Code

15025

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

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Vitabreath Pilot in Chronic Obstructive Pulmonary Disease (COPD) Patients

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