NCT02817529

Comparison of Two Positive Expiratory Pressure Devices in Stable COPD Patients

• Status: Withdrawn
• Phase: N/A
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Rush University Medical Center · Academic / Other
• Sex: All
• Age: 21 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Chronic Obstructive Pulmonary Disease (COPD)

Interventions

Type	Name	Description
DEVICE	Pulmonica	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.
DEVICE	RC-Cornet	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.

Timeline

• Start date: 2016-07-01
• Primary completion: 2017-03-01
• Completion: 2017-05-01
• First posted: 2016-06-29
• Last updated: 2017-10-25