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Comparison of Two Positive Expiratory Pressure Devices in Stable COPD Patients

Not Applicable
Withdrawn
Conditions
Chronic Obstructive Pulmonary Disease (COPD)
Registration Number
NCT02817529
Lead Sponsor
Rush University Medical Center
Brief Summary

Positive expiratory pressure (PEP) therapy is a device aiding airway clearance and secretion mobilization, also prevent the small airway from collapsing. The purpose of this research is to compare two PEP devices (Pulmonica, RC-Cornet) in stable COPD patients. Patients' compliance, satisfaction, 3 months and 6 months lung function test and life quality will be compared.

Detailed Description

Background : Positive expiratory pressure (PEP) therapy is a type of airway clearance therapy in which the patient exhales through a resistance, which helps to shift the pressure points that aid mobilization of sputum and prevent the lung from collapsing. PEP therapy helps patients reduce the need for ventilatory support, improve hyperinflation and dyspnea. Although PEP devices are used, only a few studies have compared their beneficial effects and preference among COPD patients.

Objective: The purpose of this research is to compare two PEP devices (Pulmonica, RC-Cornet) in stable COPD patients. .

Methods:

A baseline assessment of the patient will be taken at the beginning, three months and the end of six months, including patients' ability to clear secretions via Breathlessness, Cough and Sputum Scale (BCSS), patients' self-reported quality of life via St. George's Respiratory questionnaire (SGRQ) and COPD Assessment Test (CAT) scores, pt's satisfaction with each device, and cardio-pulmonary function via pulmonary function test and six minute walk test in three and six months.

Subsequently, patients will be randomly assigned a PEP device (Pulmonica, RC-Cornet) and given instructions on how to properly use the device including frequency of PEP therapy. Each patient will receive a monthly follow-up call in order to determine adherence and satisfaction with PEP therapy, also BCSS, SGRQ and CAT scores.

Recruitment & Eligibility

Status
WITHDRAWN
Sex
All
Target Recruitment
Not specified
Inclusion Criteria
  • Stable COPD patients, younger than 80 years of age, older than 21 years and are willing to participate and give consent to participate
Exclusion Criteria
  • tracheotomy

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Primary Outcome Measures
NameTimeMethod
The Breathlessness, Cough and Sputum Scale (BCSS)Within 6 months after enrollment
Secondary Outcome Measures
NameTimeMethod
6 minutes walk distance6 months after enrollment
St. George's Respiratory questionnaire (SGRQ) scoresWithin 6 months after enrollment
Hospitalization or Emergency room visits within 6 months after enrollmentWithin 6 months after enrollment
Frequency of using OPEP device dailyWithin 6 months after enrollment
COPD Assessment Test (CAT)Within 6 months after enrollment

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