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Vitabreath Pilot in Chronic Obstructive Pulmonary Disease (COPD) Patients

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ClinicalTrials.gov Identifier: NCT03349437
Recruitment Status : Completed
First Posted : November 21, 2017
Results First Posted : April 16, 2019
Last Update Posted : May 8, 2019
Sponsor:
Information provided by (Responsible Party):
Philips Respironics

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.

Condition or disease Intervention/treatment Phase
COPD Dyspnea Device: Vitabreath Device Other: Pursed Lip Breathing Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 25 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention Model Description: Participants will receive two different interventions after exertion.
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : November 6, 2017
Actual Primary Completion Date : February 20, 2018
Actual Study Completion Date : February 20, 2018

Resource links provided by the National Library of Medicine


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.




Primary Outcome Measures :
  1. 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.



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Ages Eligible for Study:   40 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03349437


Locations
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United States, Ohio
Pullmonary Rehabilition Associates
Youngstown, Ohio, United States, 44512
United States, Pennsylvania
Pittsburgh Pulmonary Associates
Jefferson Hills, Pennsylvania, United States, 15025
Sponsors and Collaborators
Philips Respironics
  Study Documents (Full-Text)

Documents provided by Philips Respironics:

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Responsible Party: Philips Respironics
ClinicalTrials.gov Identifier: NCT03349437     History of Changes
Other Study ID Numbers: HRC-17007-VBIDEPILOT-PN
First Posted: November 21, 2017    Key Record Dates
Results First Posted: April 16, 2019
Last Update Posted: May 8, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: Yes
Pediatric Postmarket Surveillance of a Device Product: No

Additional relevant MeSH terms:
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Pulmonary Disease, Chronic Obstructive
Dyspnea
Lung Diseases, Obstructive
Lung Diseases
Respiratory Tract Diseases
Respiration Disorders
Signs and Symptoms, Respiratory
Signs and Symptoms