Vitabreath Pilot in Chronic Obstructive Pulmonary Disease (COPD) Patients

COPD Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03349437
• Other study ID #: HRC-17007-VBIDEPILOT-PN
• Status: Completed
• Phase: N/A
• Start date: November 6, 2017
• Est. completion date: February 20, 2018

Study information

• Verified date: April 2019
• Source: Philips Respironics
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 25
• Est. completion date: February 20, 2018
• Est. primary completion date: February 20, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• COPD
• Dyspnea
• Pulmonary Disease, Chronic Obstructive

Intervention

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

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

Locations

Country	Name	City	State
United States	Pittsburgh Pulmonary Associates	Jefferson Hills	Pennsylvania
United States	Pullmonary Rehabilition Associates	Youngstown	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
Philips Respironics

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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