Chronic Obstructive Pulmonary Disease (COPD)NCT02817529
Comparison of Two Positive Expiratory Pressure Devices in Stable COPD Patients
A study testing Pulmonica and RC-Cornet in people with Chronic Obstructive Pulmonary Disease (COPD), run by Rush University Medical Center.
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. Read more about this study
- Who is it for?
- Ages 21 to 80 years
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease (COPD)
- What is being tested?
- Pulmonica and RC-Cornet
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Jul 2016to May 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Stable COPD patients, younger than 80 years of age, older than 21 years and are willing to participate and give consent to participate
Who cannot join
- tracheotomy
About this study
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.
Read the 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.
- Being tested
- Pulmonica, RC-Cornet
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PulmonicaDevice
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-CornetDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Device: RC-Cornet |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Breathlessness, Cough and Sputum Scale (BCSS)
Measured: Within 6 months after enrollment
Secondary outcomes (5)
COPD Assessment Test (CAT)
Measured: Within 6 months after enrollment
St. George's Respiratory questionnaire (SGRQ) scores
Measured: Within 6 months after enrollment
Hospitalization or Emergency room visits within 6 months after enrollment
Measured: Within 6 months after enrollment
Frequency of using OPEP device daily
Measured: Within 6 months after enrollment
6 minutes walk distance
Measured: 6 months after enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2016 (estimated)
- Study startJul 2016
- Primary completionMar 2017 (estimated)
- Study completionMay 2017 (estimated)
Why it stopped: Manufacture didn't provide enough information for submitting IRB approval
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Chronic Obstructive Pulmonary Disease (COPD)Studies of the same condition, open and under way.
- More trials run by Rush University Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rush University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jie Li, Principal investigator, Rush University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02817529
- Sponsor's protocol ID
- PEP 001
- Status last verified
- Oct 2017
- First submitted
- 22 Jan 2016
- Last updated
- 25 Oct 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
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.
PubMed 24005444Sethi 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.
PubMed 25625006Orlik T, Sands D. Application of positive expiratory pressure *PEP* in cystic fibrosis patient inhalations. Dev Period Med. 2015 Jan-Mar;19(1):50-9.
PubMed 26003070Bulcun 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.
PubMed 24790426
Study at a glance
From the registry record, last updated by the sponsor on 25 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Two Positive Expiratory Pressure Devices in Stable COPD Patients
- ClinicalTrials.gov ID
- NCT02817529
- Acronym / sponsor ID
- PEP 001
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Manufacture didn't provide enough information for submitting IRB approval
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Rush University Medical CenterUniversity, hospital or other
- Study start
- Jul 2016
- Primary completion
- Mar 2017 (estimated)
- Study completion
- May 2017 (estimated)
- First posted
- 29 Jun 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pulmonica | Experimental | Device: PulmonicaThe 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. |
| RC-Cornet | Active comparator | Device: RC-CornetThe 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. |
Who may qualify
- Ages
- 21 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Stable COPD patients, younger than 80 years of age, older than 21 years and are willing to participate and give consent to participate
Key exclusion criteria (1 listed)
- tracheotomy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PulmonicaThe 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 | Pulmonica |
| RC-CornetRC-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. | Device | RC-Cornet |
Primary outcome
The Breathlessness, Cough and Sputum Scale (BCSS)
Time frame: Within 6 months after enrollment
5 secondary outcomes
COPD Assessment Test (CAT)
Time frame: Within 6 months after enrollment
St. George's Respiratory questionnaire (SGRQ) scores
Time frame: Within 6 months after enrollment
Hospitalization or Emergency room visits within 6 months after enrollment
Time frame: Within 6 months after enrollment
Frequency of using OPEP device daily
Time frame: Within 6 months after enrollment
6 minutes walk distance
Time frame: 6 months after enrollment
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Oct 2017.
- Background: PubMed 24005444Osadnik 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.
- Background: PubMed 25625006Sethi 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.
- Background: PubMed 26003070Orlik T, Sands D. Application of positive expiratory pressure *PEP* in cystic fibrosis patient inhalations. Dev Period Med. 2015 Jan-Mar;19(1):50-9.
- Background: PubMed 24790426Bulcun 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jie Li principal investigator
Rush University Medical Center
Questions about this trial
What is this clinical trial studying?
A study testing Pulmonica and RC-Cornet in people with Chronic Obstructive Pulmonary Disease (COPD), run by Rush University Medical Center.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 25 Oct 2017. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The Breathlessness, Cough and Sputum Scale (BCSS) (time frame: Within 6 months after enrollment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02817529, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Oct 2017.