Comparison of Two Positive Expiratory Pressure Devices in Stable COPD Patients

NCT02817529 | Withdrawn

• 1 other identifier: PEP 001
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Chronic Obstructive Pulmonary Disease (COPD)

Outcome Measures

Primary Outcomes (1)

• The Breathlessness, Cough and Sputum Scale (BCSS)

  Within 6 months after enrollment

Secondary Outcomes (5)

• 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

Study Arms (2)

Pulmonica

EXPERIMENTAL

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

RC-Cornet

ACTIVE COMPARATOR

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

Interventions

Pulmonica DEVICE

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.

Pulmonica

RC-Cornet DEVICE

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.

RC-Cornet

Eligibility Criteria

• Age: 21 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Stable COPD patients, younger than 80 years of age, older than 21 years and are willing to participate and give consent to participate

You may not qualify if:

• tracheotomy

Sponsors & Collaborators

• Rush University Medical Center: lead

Related Publications (4)

• 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.

  PMID: 24005444 BACKGROUND

• 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.

  PMID: 25625006 BACKGROUND

• 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.

  PMID: 26003070 BACKGROUND

• 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.

  PMID: 24790426 BACKGROUND

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Jie Li

  Rush University Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 22, 2016
• First Posted: June 29, 2016
• Study Start: July 1, 2016
• Primary Completion: March 1, 2017
• Study Completion: May 1, 2017
• Last Updated: October 25, 2017

Record last verified: 2017-10

Data Sharing

• IPD Sharing: Will not share