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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01101282
Recruitment Status : Completed
First Posted : April 9, 2010
Last Update Posted : February 15, 2013
Sponsor:
Collaborators:
The Alfred
Austin Hospital, Melbourne Australia
Information provided by (Responsible Party):
Christian Osadnik, La Trobe University

Tracking Information
First Submitted Date  ICMJE April 7, 2010
First Posted Date  ICMJE April 9, 2010
Last Update Posted Date February 15, 2013
Study Start Date  ICMJE July 2010
Actual Primary Completion Date January 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 8, 2010)
  • Symptom severity [ Time Frame: Within 48 hours of presenting to hospital (day 1) ]
    Measured via the Breathlessness, Cough and Sputum Scale (BCSS).
  • Symptom severity [ Time Frame: At hospital discharge (up to approx. day 10) ]
    Measured via the BCSS
  • Symptom severity [ Time Frame: 8 weeks following hospital discharge ]
    Measured via the BCSS
  • Symptom severity [ Time Frame: 6 months following hospital discharge ]
    Measured via the BCSS
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 8, 2010)
  • 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).
  • Disease-specific quality of life [ Time Frame: 8 weeks following hospital discharge ]
    Measured via the SGRQ
  • Disease-specific quality of life [ Time Frame: 6 months following hospital discharge ]
    Measured via the SGRQ
  • 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.
  • Hospital length of stay [ Time Frame: At hospital discharge (up to approx. day 10) ]
    Measured as number of days
  • Time to first exacerbation [ Time Frame: 6 months following hospital discharge ]
    Measured as number of days
  • Time to first hospitalisation (due to respiratory illness) [ Time Frame: 6 months following hospital discharge ]
    Measured as number of days
  • Number of acute exacerbations [ Time Frame: 6 months following hospital discharge ]
    Measured as number of events
  • Number of hospitalisations (due to respiratory illness) [ Time Frame: 6 months following hospital discharge ]
    Measured as number of events
  • Total number of hospitalised days [ Time Frame: 6 months following hospital discharge ]
    Measured as number of hospitalised days
  • Lung function (spirometry) [ Time Frame: At hospital discharge (up to approx. day 10) ]
    e.g. FEV1, FVC, FEV1/FVC%
  • Lung function (spirometry) [ Time Frame: 6 months following hospital discharge ]
    e.g. FEV1, FVC, FEV1/FVC%
  • Mortality (actual, all cause) [ Time Frame: At hospital discharge (up to approx. day 10) ]
    Measured as number of events
  • Mortality (actual, all cause) [ Time Frame: 6 months following hospital discharge ]
    Measured as number of events
  • 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).
  • Mortality (predicted) [ Time Frame: 6 months following hospital discharge ]
    Measured via BODE index
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Does Positive Expiratory Pressure Mask Therapy Improve Recovery From Acute Exacerbations of Chronic Obstructive Pulmonary Disease?
Official Title  ICMJE 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)?
Brief Summary 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.
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  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Pulmonary Disease, Chronic Obstructive
  • Lung Diseases, Obstructive
Intervention  ICMJE 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).
Study Arms  ICMJE
  • 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
    Intervention: Device: Positive expiratory pressure (PEP) mask therapy
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: February 13, 2013)
92
Original Estimated Enrollment  ICMJE
 (submitted: April 8, 2010)
116
Actual Study Completion Date  ICMJE January 2013
Actual Primary Completion Date January 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE Child, Adult, Older Adult
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Australia
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01101282
Other Study ID Numbers  ICMJE (not yet specified)
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party Christian Osadnik, La Trobe University
Original Responsible Party Mr. Christian Osadnik, La Trobe University
Current Study Sponsor  ICMJE La Trobe University
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE
  • The Alfred
  • Austin Hospital, Melbourne Australia
Investigators  ICMJE
Principal Investigator: Christian R Osadnik, Bachelor of Physiotherapy La Trobe University
PRS Account La Trobe University
Verification Date February 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP