Comparison of Two Positive Expiratory Pressure Devices in Stable COPD Patients

Study Overview
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Brief Summary
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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
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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.

Official Title
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Comparison of Two Positive Expiratory Pressure Devices in Stable COPD Patients

Conditions
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Chronic Obstructive Pulmonary Disease (COPD)

Intervention / Treatment
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* Device: Pulmonica
* Device: RC-Cornet


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Pulmonica<br>The Pulmonica is a specially constructed and tuned Pulmonary Harmonica that produces deep, resonant, meditative sounds that can be felt vibrating in the lungs and sinuses. Participants who will be instructed to inhale and exhale through the PEP device at least ten times daily for up to six months. | Device: Pulmonica<br>* The Pulmonica is a specially constructed and tuned Pulmonary Harmonica that produces deep, resonant, meditative sounds that can be felt vibrating in the lungs and sinuses. Participants who will be instructed to inhale and exhale through Pulmonica at least ten times daily for up to six months.<br>|
| Active Comparator: RC-Cornet<br>The RC-Cornet is a device that provides oscillatory positive expiratory pressure (OPEP) therapy for the detachment and removal of pulmonary secretions. Through variable pressure settings and optional aerosolized medication delivery, patients realize maximum efficacy specific to their unique clinical needs.The RC-Cornet uses the patient's full expired air volume to produce pressure and oscillatory vibrations. Participants who will be instructed to inhale and exhale through the PEP device at least ten times daily for up to six months. | Device: RC-Cornet<br>* RC-Cornet is an oscillatory positive expiratory pressure device, which is designed to aid in the loosening and removal of mucus build-up in the lungs. Participants who will be instructed to inhale and exhale through RC-Cornet at least ten times daily for up to six months.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The Breathlessness, Cough and Sputum Scale (BCSS) |  | Within 6 months after enrollment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| COPD Assessment Test (CAT) |  | Within 6 months after enrollment | 
| St. George's Respiratory questionnaire (SGRQ) scores |  | Within 6 months after enrollment | 
| Hospitalization or Emergency room visits within 6 months after enrollment |  | Within 6 months after enrollment | 
| Frequency of using OPEP device daily |  | Within 6 months after enrollment | 
| 6 minutes walk distance |  | 6 months after enrollment |