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.

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Key information

Conditions

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

Age range

40 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Pullmonary Rehabilition Associates, Youngstown, Ohio, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

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

Pursed lip breathing

Other

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

Primary outcomes

Average Distance During Modified 6 Minute Walk Test

Time frame: 15 minutes

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.

Sponsors and collaborators

Lead sponsor

Philips Respironics

Industry

Registry information

Official study 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

Important dates

Study start: 2017
Primary completion: 2018
Study completion: 2018
First posted: Nov 21, 2017
Registry last updated: May 8, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed