Does Positive Expiratory Pressure Mask Therapy Improve Recovery From Acute Exacerbations of Chronic Obstructive Pulmonary Disease?

February 13, 2013 updated by: Christian Osadnik, La Trobe University

Does the Addition of Positive Expiratory Pressure (PEP) Mask Therapy to Usual Medical Care Improve Patients' Symptoms, Quality or Life and Risk of Future Exacerbations in Individuals With Acute Exacerbations of Chronic Obstructive Pulmonary Disease (COPD)?

This study aims to identify whether the addition of positive expiratory pressure (PEP) mask therapy to standard medical care improves clinically important outcomes in individuals with acute exacerbations of chronic obstructive pulmonary disease. It is hypothesized that those who receive the additional PEP mask therapy will show greater improvements than those who do not.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

This study aims to identify whether the addition of positive expiratory pressure (PEP) mask therapy to standard medical care improves symptoms, quality of life and risk of re-exacerbation in individuals with acute exacerbations of chronic obstructive pulmonary disease.

A PEP mask is a small hand-held device that is self-applied over the nose and mouth. It creates a resistance against exhalation (outward) breaths which helps facilitate movement of sputum from the lungs towards the mouth.

Participants will be recruited from two tertiary metropolitan hospitals in Melbourne, Australia and randomised to receive either 'usual care' (comprising medical management, non-invasive ventilation if required, rehabilitation and allied health interventions) or 'usual care' plus PEP mask therapy for the duration of their hospital admission. All participants will then complete daily diaries for six months after discharge.

The effect of PEP mask therapy will be evaluated using a range of outcomes important to both patients and health care providers.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
92

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
    • Victoria
      • Melbourne, Victoria, Australia, 3181
        • The Alfred Hospital
      • Melbourne, Victoria, Australia, 3084
        • The Austin Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria (all of the following criteria must be met):

  • The primary reason for hospital admission is an acute exacerbation of clinically diagnosed COPD
  • There is evidence of sputum expectoration or they are a chronic sputum producer ('regularly expectorates sputum on most days')
  • They are able and willing to provide written, informed consent
  • Recent (within the last 6 months) lung function data indicates obstructive lung disease (of any severity), according to the GOLD criteria: post-bronchodilator FEV1/FVC < 0.7 (only if available)
  • They have a smoking history of ≥ 10 pack/years (only if diagnosis unclear)

Exclusion Criteria (none of the following criteria must be present):

  • They are breathing via an artificial airway (e.g. endotracheal or tracheostomy tube)
  • They have a more significant respiratory disease other than COPD (e.g. primary diagnosis of bronchiectasis, cystic fibrosis, interstitial lung disease, asthma, lung cancer)
  • They have had recent (within the last 6 months) lung volume reduction procedure(s) (e.g. surgery, valve or stent insertion, or other), lung transplantation or pneumonectomy
  • The intervention is contraindicated (including but not limited to evidence of undrained pneumothorax, significant frank haemoptysis, recent facial, oral, oesophageal or skull surgery/trauma, altered conscious state or inability to co-operate)
  • They have poor oxygen saturation at rest (SpO2 < 88%) despite supplemental oxygen delivered via nasal prongs
  • They intend to continue performing established ACT routines throughout the study period
  • It is more than 48 hours since being admitted as an inpatient to hospital.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
No Intervention: 'Usual care'

Participants will receive 'usual medical care' consisting of the following:

  • Medical management: Bronchodilators, corticosteroids, antibiotics and supplemental oxygen will be provided (where appropriate) in accordance with Australian and New Zealand COPD management guidelines (COPDX guidelines).
  • Non-invasive ventilation: if clinically indicated and prescribed in accordance with standardised hospital guidelines.
  • Physical rehabilitation: Participants will be assessed by a physiotherapist and prescribed appropriate exercises to facilitate a safe and timely discharge. Participants will perform physical rehabilitation according to a standardised protocol with an aim of maximising physical function at discharge.
  • Other allied health (e.g. occupational therapy, speech pathology, dietician) assessments and interventions, as required.
Experimental: 'Usual care' plus PEP mask therapy

This will comprise:

  • 'Usual care'
  • PEP mask therapy
Device: Positive expiratory pressure (PEP) mask therapy
PEP mask therapy will be performed once/day, supervised, by an experienced physiotherapist until hospital discharge or ≥ 24 hours without sputum expectoration (whichever comes first). Written instructions shall also be provided, encouraging two more independent PEP mask sessions per day. Each session will comprise up to 5 cycles of 8-10 slightly active breaths, followed by 2 huffs (FET) and 2 coughs. A target pressure of 10-20 cms H20 during the middle of expiration shall be used (monitored via a pressure manometer).

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Symptom severity
Time Frame: Within 48 hours of presenting to hospital (day 1)
Measured via the Breathlessness, Cough and Sputum Scale (BCSS).
Within 48 hours of presenting to hospital (day 1)
Symptom severity
Time Frame: At hospital discharge (up to approx. day 10)
Measured via the BCSS
At hospital discharge (up to approx. day 10)
Symptom severity
Time Frame: 8 weeks following hospital discharge
Measured via the BCSS
8 weeks following hospital discharge
Symptom severity
Time Frame: 6 months following hospital discharge
Measured via the BCSS
6 months following hospital discharge

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Disease-specific quality of life
Time Frame: Within 48 hours of presenting to hospital (day 1)
Measured via the 4-week English (Australian) version of the St. George's Respiratory Questionnaire (SGRQ).
Within 48 hours of presenting to hospital (day 1)
Disease-specific quality of life
Time Frame: 8 weeks following hospital discharge
Measured via the SGRQ
8 weeks following hospital discharge
Disease-specific quality of life
Time Frame: 6 months following hospital discharge
Measured via the SGRQ
6 months following hospital discharge
Need for assisted (non-invasive and/or invasive) ventilation during hospitalisation (within, and after 48 hours of presentation to hospital)
Time Frame: At hospital discharge (up to approx. day 10)
The number of participants needing non-invasive or invasive ventilation during their inpatient stay shall be assessed. As early non-invasive ventilation is commonly used for the management of acute exacerbations of COPD, this outcome shall be assessed both within and after 48 hours of presentation to hospital. This aims to differentiate usual care from clinical deterioration.
At hospital discharge (up to approx. day 10)
Hospital length of stay
Time Frame: At hospital discharge (up to approx. day 10)
Measured as number of days
At hospital discharge (up to approx. day 10)
Time to first exacerbation
Time Frame: 6 months following hospital discharge
Measured as number of days
6 months following hospital discharge
Time to first hospitalisation (due to respiratory illness)
Time Frame: 6 months following hospital discharge
Measured as number of days
6 months following hospital discharge
Number of acute exacerbations
Time Frame: 6 months following hospital discharge
Measured as number of events
6 months following hospital discharge
Number of hospitalisations (due to respiratory illness)
Time Frame: 6 months following hospital discharge
Measured as number of events
6 months following hospital discharge
Total number of hospitalised days
Time Frame: 6 months following hospital discharge
Measured as number of hospitalised days
6 months following hospital discharge
Lung function (spirometry)
Time Frame: At hospital discharge (up to approx. day 10)
e.g. FEV1, FVC, FEV1/FVC%
At hospital discharge (up to approx. day 10)
Lung function (spirometry)
Time Frame: 6 months following hospital discharge
e.g. FEV1, FVC, FEV1/FVC%
6 months following hospital discharge
Mortality (actual, all cause)
Time Frame: At hospital discharge (up to approx. day 10)
Measured as number of events
At hospital discharge (up to approx. day 10)
Mortality (actual, all cause)
Time Frame: 6 months following hospital discharge
Measured as number of events
6 months following hospital discharge
Mortality (predicted)
Time Frame: At hospital discharge (up to approx. day 10)
Measured via calculation of the BODE index. The BODE index is derived from: Body mass index, Obstruction severity (spirometry), Dyspnoea (MRC dyspnoea scale) and Exercise tolerance (6 minute walk test).
At hospital discharge (up to approx. day 10)
Mortality (predicted)
Time Frame: 6 months following hospital discharge
Measured via BODE index
6 months following hospital discharge

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
La Trobe University

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
The Alfred
Austin Hospital, Melbourne Australia

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Christian R Osadnik, Bachelor of Physiotherapy, La Trobe University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 1, 2010

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 1, 2013

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 1, 2013

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 7, 2010

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 8, 2010

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 9, 2010

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 15, 2013

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 13, 2013

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • (not yet specified)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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