Chronic Obstructive Pulmonary DiseaseNCT03094806
Vibratory PEP Device and Hospital Length of Stay for Acute Exacerbation of COPD
A study of Chronic Obstructive Pulmonary Disease, run by New York Presbyterian Brooklyn Methodist Hospital at 1 site in United States.
Trial summary
This study is evaluating the use of a respiratory device, the Acapella Vibratory Positive Expiratory Pressure (PEP) Therapy device, in patients admitted to the hospital with a chronic obstructive pulmonary disease (COPD) exacerbation. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 91 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2013to Dec 2015
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Admitted with COPD exacerbation as a primary diagnosis
- Subjectively produces more than 1 tablespoon (15 ml) / day of sputum
- Has the subjective feeling that he/she cannot cough up or clear her secretions
- Physical respiratory system exam by the physician with evidence of course ronchi suggestive of impacted secretions
- > 10 pack-year smoking history
Who cannot join
- Cannot use the flutter device or unable to follow commands
- Altered mental status
- Known active malignancy
- Known systolic congestive heart failure (CHF) with ejection fraction (EF) < 40% or clinically in acute CHF exacerbation as documented by cardiologist or primary diagnosis other than COPD
- Pregnancy
- Patients in severe exacerbation (Intubated, Continuous use of NIPPV, Unable to speak full sentences)
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- Intracranial pressure (ICP) >20 mmHg
- Hemodynamic instability (requiring vasopressor support)
- Recent facial, oral, or skull surgery or trauma.
- Acute sinusitis.
- Epistaxis.
- Esophageal surgery.
- Active Hemoptysis (More than 2 tablespoons of frank blood per day)
- Nausea.
- Severe earache or discharge from ear. (Known or suspected tympanic membrane rupture or other middle ear pathology)
- Untreated pneumothorax.
Trial locations and contacts
1 site in 1 country.
United States1 site
New York Methodist Hospital
Brooklyn, New York, 11215
About this study
Official title: Vibratory/Positive Expiratory Pressure Device and Hospital Length of Stay for Acute Exacerbation of Chronic Obstructive Pulmonary Disease
This study is evaluating the use of a respiratory device, the Acapella Vibratory Positive Expiratory Pressure (PEP) Therapy device, in patients admitted to the hospital with a chronic obstructive pulmonary disease (COPD) exacerbation.
Read the detailed description
The investigators hypothesize that the PEP-FV used as adjunctive therapy in patients hospitalized for an acute exacerbation of COPD will result in decreased hospital length of stay and improvement of overall COPD-related health outcomes.
- Conditions
- Chronic Obstructive Pulmonary Disease
- Being tested
- Acapella Vibratory PEP Therapy Device plus usual care, Sham Acapella Vibratory PEP Device plus usual care
- 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.
Acapella Vibratory PEP Therapy Device plus usual careDevice
The acapella® Vibratory PEP Therapy System (PEP-FV) device is a handheld device that operates in same principle as standard FV. Unlike standard FV, it is not gravity dependent. It comes in two different devices to accommodate for different flows rates of the patient. It has similar properties of a standard FV and may be better tolerated.
Sham Acapella Vibratory PEP Device plus usual careDevice
The Sham Acapella Vibratory PEP Device is the same as the Therapy Device, except the flutter valve has been removed from the device.
| Study group | Role | What they receive |
|---|---|---|
| Acapella Vibratory PEP Therapy Device | Experimental | Subject will use the device 3 times a day throughout hospital stay Receives: Device: Acapella Vibratory PEP Therapy Device plus usual care |
| Sham Acapella Vibratory PEP Device | Placebo comparator | Subject will use the sham device 3 times a day throughout hospital stay Receives: Device: Sham Acapella Vibratory PEP Device plus usual care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Length of Stay
Time of admission to time of discharge from hospital
Measured: Up to 2 weeks
Secondary outcomes (6)
Analysis of Change in Daily Sputum Production
Sputum production in a 24 hour period in mL volume
Measured: Up to 5 days
Dyspnea on the Borg Scale
Scale is used to rate the difficulty of breathing. It starts at 0 where the breathing is causing no difficulty at all and progresses through to number 10 where the breathing difficulty is maximal.
Measured: Up to 5 days
Dyspnea on the MMRC Scale
The Modified Medical Research Council (MMRC) dyspnea scale is used to assess an individual's shortness of breath. It starts at 0 where the shortness of breath occurs during strenuous exercise and progresses through to number 4 where the shortness of breath is maximal.
Measured: Up to 5 days
Change in 6MWT Test
A six-minute walk test (6MWT) measures the distance that an individual can walk on a flat, hard surface in a period of six minutes. This is used to assess the exercise tolerance measured by the difference in meters between the tests.
Measured: Day 1 and Day 5
Difference in Bedside Spirometry
Degree of airflow obstruction (FEV1/FVC)
Measured: Day 5
In Hospital Mortality
Death at the time of discharge
Measured: Up to 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Mar 2017
- Study startOct 2013
- Primary completionOct 2015
- Study completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Chronic Obstructive Pulmonary DiseaseStudies of the same condition, open and under way.
- 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 91 participants (actual)
Sponsor and investigators
- Lead sponsor
- New York Presbyterian Brooklyn Methodist Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jeremy Weingarten, MD, New York Presbyterian Brooklyn Methodist Hospital
- Investigators
- Jeremy A Weingarten, MD, Principal investigator, New York Presbyterian Brooklyn Methodist Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03094806
- Sponsor's protocol ID
- 470455
- Status last verified
- Mar 2024
- First submitted
- 27 May 2015
- Last updated
- 21 Mar 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Milan S, Bondalapati P, Megally M, Patel E, Vaghasia P, Gross L, Bachman EM, Chadha P, Weingarten JA. Positive Expiratory Pressure Therapy With And Without Oscillation And Hospital Length Of Stay For Acute Exacerbation Of Chronic Obstructive Pulmonary Disease. Int J Chron Obstruct Pulmon Dis. 2019 Nov 20;14:2553-2561. doi: 10.2147/COPD.S213546. eCollection 2019.
PubMed 31819393
Study at a glance
From the registry record, last updated by the sponsor on 21 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Vibratory/Positive Expiratory Pressure Device and Hospital Length of Stay for Acute Exacerbation of Chronic Obstructive Pulmonary Disease
- ClinicalTrials.gov ID
- NCT03094806
- Acronym / sponsor ID
- 470455
- Conditions
- Chronic Obstructive Pulmonary Disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 91 participants (actual)
- Lead sponsor
- New York Presbyterian Brooklyn Methodist HospitalUniversity, hospital or other
- Study start
- Oct 2013
- Primary completion
- Oct 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 29 Mar 2017 (actual)
- Results
- Posted 11 Oct 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is evaluating the use of a respiratory device, the Acapella Vibratory Positive Expiratory Pressure (PEP) Therapy device, in patients admitted to the hospital with a chronic obstructive pulmonary disease (COPD) exacerbation.
Detailed description
The investigators hypothesize that the PEP-FV used as adjunctive therapy in patients hospitalized for an acute exacerbation of COPD will result in decreased hospital length of stay and improvement of overall COPD-related health outcomes.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Acapella Vibratory PEP Therapy Device | Experimental | Device: Acapella Vibratory PEP Therapy Device plus usual careSubject will use the device 3 times a day throughout hospital stay |
| Sham Acapella Vibratory PEP Device | Placebo comparator | Device: Sham Acapella Vibratory PEP Device plus usual careSubject will use the sham device 3 times a day throughout hospital stay |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Admitted with COPD exacerbation as a primary diagnosis
- Subjectively produces more than 1 tablespoon (15 ml) / day of sputum
- Has the subjective feeling that he/she cannot cough up or clear her secretions
- Physical respiratory system exam by the physician with evidence of course ronchi suggestive of impacted secretions
- > 10 pack-year smoking history
Key exclusion criteria (16 listed)
- Cannot use the flutter device or unable to follow commands
- Altered mental status
- Known active malignancy
- Known systolic congestive heart failure (CHF) with ejection fraction (EF) < 40% or clinically in acute CHF exacerbation as documented by cardiologist or primary diagnosis other than COPD
- Pregnancy
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 |
|---|---|---|
| Acapella Vibratory PEP Therapy Device plus usual careThe acapella® Vibratory PEP Therapy System (PEP-FV) device is a handheld device that operates in same principle as standard FV. Unlike standard FV, it is not gravity dependent. It comes in two different devices to accommodate for different flows rates of the patient. It has similar properties of a standard FV and may be better tolerated. | Device | Acapella Vibratory PEP Therapy Device |
| Sham Acapella Vibratory PEP Device plus usual careThe Sham Acapella Vibratory PEP Device is the same as the Therapy Device, except the flutter valve has been removed from the device. | Device | Sham Acapella Vibratory PEP Device |
Primary outcome
Length of Stay
Time frame: Up to 2 weeks
Time of admission to time of discharge from hospital
6 secondary outcomes
Analysis of Change in Daily Sputum Production
Time frame: Up to 5 days
Dyspnea on the Borg Scale
Time frame: Up to 5 days
Dyspnea on the MMRC Scale
Time frame: Up to 5 days
Change in 6MWT Test
Time frame: Day 1 and Day 5
Difference in Bedside Spirometry
Time frame: Day 5
In Hospital Mortality
Time frame: Up to 2 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Mar 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 31819393Milan S, Bondalapati P, Megally M, Patel E, Vaghasia P, Gross L, Bachman EM, Chadha P, Weingarten JA. Positive Expiratory Pressure Therapy With And Without Oscillation And Hospital Length Of Stay For Acute Exacerbation Of Chronic Obstructive Pulmonary Disease. Int J Chron Obstruct Pulmon Dis. 2019 Nov 20;14:2553-2561. doi: 10.2147/COPD.S213546. eCollection 2019.
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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.
Jeremy A Weingarten, MD principal investigator
New York Presbyterian Brooklyn Methodist Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study of Chronic Obstructive Pulmonary Disease, run by New York Presbyterian Brooklyn Methodist Hospital at 1 site in United States.
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 5 inclusion and 16 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: finished, as of the sponsor's last update on 21 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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?
Yes. Results are posted in the registry (first posted 11 Oct 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Length of Stay (time frame: Up to 2 weeks). 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 NCT03094806, which also lists 1 linked publication.
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 21 Mar 2024; AzTrials last refreshed its copy on 8 Nov 2026.