Comparison of Two Positive Expiratory Pressure Devices in Stable COPD Patients

Chronic Obstructive Pulmonary Disease (COPD) Clinical Trial

Official title:

Comparison of Two Positive Expiratory Pressure Devices in Stable COPD Patients

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02817529
• Other study ID #: PEP 001
• Status: Withdrawn
• Phase: N/A
• First received: January 22, 2016
• Last updated: October 24, 2017
• Start date: July 2016
• Est. completion date: May 2017

Study information

• Verified date: October 2017
• Source: Rush University Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: May 2017
• Est. primary completion date: March 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Chronic Obstructive Pulmonary Disease (COPD)
• Lung Diseases
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive

Intervention

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.
• 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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Rush University Medical Center

References & Publications (4)

Bulcun E, Ekici M, Ekici A. Assessment of patients' preferences regarding the characteristics associated with the treatment of chronic obstructive pulmonary disease. Int J Chron Obstruct Pulmon Dis. 2014 Apr 16;9:363-8. doi: 10.2147/COPD.S56229. eCollection 2014. — View Citation

Orlik T, Sands D. Application of positive expiratory pressure *PEP* in cystic fibrosis patient inhalations. Dev Period Med. 2015 Jan-Mar;19(1):50-9. — View Citation

Osadnik CR, McDonald CF, Miller BR, Hill CJ, Tarrant B, Steward R, Chao C, Stodden N, Oliveira CC, Gagliardi N, Holland AE. The effect of positive expiratory pressure (PEP) therapy on symptoms, quality of life and incidence of re-exacerbation in patients with acute exacerbations of chronic obstructive pulmonary disease: a multicentre, randomised controlled trial. Thorax. 2014 Feb;69(2):137-43. doi: 10.1136/thoraxjnl-2013-203425. Epub 2013 Sep 4. — View Citation

Sethi S, Yin J, Anderson PK. Lung flute improves symptoms and health status in COPD with chronic bronchitis: A 26 week randomized controlled trial. Clin Transl Med. 2014 Sep 23;3:29. doi: 10.1186/s40169-014-0029-y. eCollection 2014. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The Breathlessness, Cough and Sputum Scale (BCSS)		Within 6 months after enrollment
Secondary	COPD Assessment Test (CAT)		Within 6 months after enrollment
Secondary	St. George's Respiratory questionnaire (SGRQ) scores		Within 6 months after enrollment
Secondary	Hospitalization or Emergency room visits within 6 months after enrollment		Within 6 months after enrollment
Secondary	Frequency of using OPEP device daily		Within 6 months after enrollment
Secondary	6 minutes walk distance		6 months after enrollment