- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01101282
Does Positive Expiratory Pressure Mask Therapy Improve Recovery From Acute Exacerbations of Chronic Obstructive Pulmonary Disease?
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)?
Study Overview
Status
Intervention / Treatment
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
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Victoria
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Melbourne, Victoria, Australia, 3181
- The Alfred Hospital
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Melbourne, Victoria, Australia, 3084
- The Austin Hospital
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Genders Eligible for Study
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
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
No Intervention: 'Usual care'
Participants will receive 'usual medical care' consisting of the following:
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|
Experimental: 'Usual care' plus PEP mask therapy
This will comprise:
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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).
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What is the study measuring?
Primary Outcome Measures
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)
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Symptom severity
Time Frame: 8 weeks following hospital discharge
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Measured via the BCSS
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8 weeks following hospital discharge
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Symptom severity
Time Frame: 6 months following hospital discharge
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Measured via the BCSS
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6 months following hospital discharge
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Disease-specific quality of life
Time Frame: Within 48 hours of presenting to hospital (day 1)
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Measured via the 4-week English (Australian) version of the St. George's Respiratory Questionnaire (SGRQ).
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Within 48 hours of presenting to hospital (day 1)
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Disease-specific quality of life
Time Frame: 8 weeks following hospital discharge
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Measured via the SGRQ
|
8 weeks following hospital discharge
|
Disease-specific quality of life
Time Frame: 6 months following hospital discharge
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Measured via the SGRQ
|
6 months following hospital discharge
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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.
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At hospital discharge (up to approx. day 10)
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Hospital length of stay
Time Frame: At hospital discharge (up to approx. day 10)
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Measured as number of days
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At hospital discharge (up to approx. day 10)
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Time to first exacerbation
Time Frame: 6 months following hospital discharge
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Measured as number of days
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6 months following hospital discharge
|
Time to first hospitalisation (due to respiratory illness)
Time Frame: 6 months following hospital discharge
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Measured as number of days
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6 months following hospital discharge
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Number of acute exacerbations
Time Frame: 6 months following hospital discharge
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Measured as number of events
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6 months following hospital discharge
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Number of hospitalisations (due to respiratory illness)
Time Frame: 6 months following hospital discharge
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Measured as number of events
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6 months following hospital discharge
|
Total number of hospitalised days
Time Frame: 6 months following hospital discharge
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Measured as number of hospitalised days
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6 months following hospital discharge
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Lung function (spirometry)
Time Frame: At hospital discharge (up to approx. day 10)
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e.g. FEV1, FVC, FEV1/FVC%
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At hospital discharge (up to approx. day 10)
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Lung function (spirometry)
Time Frame: 6 months following hospital discharge
|
e.g. FEV1, FVC, FEV1/FVC%
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6 months following hospital discharge
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Mortality (actual, all cause)
Time Frame: At hospital discharge (up to approx. day 10)
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Measured as number of events
|
At hospital discharge (up to approx. day 10)
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Mortality (actual, all cause)
Time Frame: 6 months following hospital discharge
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Measured as number of events
|
6 months following hospital discharge
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Mortality (predicted)
Time Frame: At hospital discharge (up to approx. day 10)
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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).
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At hospital discharge (up to approx. day 10)
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Mortality (predicted)
Time Frame: 6 months following hospital discharge
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Measured via BODE index
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6 months following hospital discharge
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Christian R Osadnik, Bachelor of Physiotherapy, La Trobe University
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- (not yet specified)
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