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Comparison of Two Positive Expiratory Pressure Devices in Stable COPD Patients

Primary Purpose

Chronic Obstructive Pulmonary Disease (COPD)

Status
Withdrawn
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Pulmonica
RC-Cornet
Sponsored by
Rush University Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Obstructive Pulmonary Disease (COPD)

Eligibility Criteria

21 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    Pulmonica

    RC-Cornet

    Arm Description

    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.

    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.

    Outcomes

    Primary Outcome Measures

    The Breathlessness, Cough and Sputum Scale (BCSS)

    Secondary Outcome Measures

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

    Full Information

    First Posted
    January 22, 2016
    Last Updated
    October 24, 2017
    Sponsor
    Rush University Medical Center
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02817529
    Brief Title
    Comparison of Two Positive Expiratory Pressure Devices in Stable COPD Patients
    Official Title
    Comparison of Two Positive Expiratory Pressure Devices in Stable COPD Patients
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    October 2017
    Overall Recruitment Status
    Withdrawn
    Why Stopped
    Manufacture didn't provide enough information for submitting IRB approval
    Study Start Date
    July 2016 (undefined)
    Primary Completion Date
    March 2017 (Anticipated)
    Study Completion Date
    May 2017 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Rush University Medical Center

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Chronic Obstructive Pulmonary Disease (COPD)

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    0 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Pulmonica
    Arm Type
    Experimental
    Arm Description
    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.
    Arm Title
    RC-Cornet
    Arm Type
    Active Comparator
    Arm Description
    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.
    Intervention Type
    Device
    Intervention Name(s)
    Pulmonica
    Intervention Description
    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.
    Intervention Type
    Device
    Intervention Name(s)
    RC-Cornet
    Intervention Description
    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.
    Primary Outcome Measure Information:
    Title
    The Breathlessness, Cough and Sputum Scale (BCSS)
    Time Frame
    Within 6 months after enrollment
    Secondary Outcome Measure Information:
    Title
    COPD Assessment Test (CAT)
    Time Frame
    Within 6 months after enrollment
    Title
    St. George's Respiratory questionnaire (SGRQ) scores
    Time Frame
    Within 6 months after enrollment
    Title
    Hospitalization or Emergency room visits within 6 months after enrollment
    Time Frame
    Within 6 months after enrollment
    Title
    Frequency of using OPEP device daily
    Time Frame
    Within 6 months after enrollment
    Title
    6 minutes walk distance
    Time Frame
    6 months after enrollment

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    21 Years
    Maximum Age & Unit of Time
    80 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Jie Li
    Organizational Affiliation
    Rush University Medical Center
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    Citations:
    PubMed Identifier
    24005444
    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.
    Results Reference
    background
    PubMed Identifier
    25625006
    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.
    Results Reference
    background
    PubMed Identifier
    26003070
    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.
    Results Reference
    background
    PubMed Identifier
    24790426
    Citation
    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.
    Results Reference
    background

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    Comparison of Two Positive Expiratory Pressure Devices in Stable COPD Patients

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