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

• ClinicalTrials.gov Identifier: NCT01101282
• Recruitment Status: Completed
• First Posted: April 9, 2010
• Last Update Posted: February 15, 2013
• Sponsor: La Trobe University
• Collaborators: The Alfred; Austin Hospital, Melbourne Australia
• Information provided by (Responsible Party): Christian Osadnik, La Trobe University

Tracking Information

• First Submitted Date: April 7, 2010
• First Posted Date: April 9, 2010
• Last Update Posted Date: February 15, 2013
• Study Start Date: July 2010
• Actual Primary Completion Date: January 2013 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (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: Same as current

Current Secondary Outcome Measures (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: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Does Positive Expiratory Pressure Mask Therapy Improve Recovery From Acute Exacerbations of Chronic Obstructive Pulmonary Disease?
• Official Title: 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: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Single (Outcomes Assessor); Primary Purpose: Treatment

Condition

• Pulmonary Disease, Chronic Obstructive
• Lung Diseases, Obstructive

Intervention

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

• 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

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: February 13, 2013): 92
• Original Estimated Enrollment (submitted: April 8, 2010): 116
• Actual Study Completion Date: January 2013
• Actual Primary Completion Date: January 2013 (Final data collection date for primary outcome measure)

Eligibility Criteria

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

• Sexes Eligible for Study: All

• Ages: Child, Adult, Older Adult
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Australia

Administrative Information

• NCT Number: NCT01101282
• Other Study ID Numbers: (not yet specified)
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Current Responsible Party: Christian Osadnik, La Trobe University
• Original Responsible Party: Mr. Christian Osadnik, La Trobe University
• Current Study Sponsor: La Trobe University
• Original Study Sponsor: Same as current

Collaborators

• The Alfred
• Austin Hospital, Melbourne Australia

Investigators

• Principal Investigator: Christian R Osadnik, Bachelor of Physiotherapy; La Trobe University

• PRS Account: La Trobe University
• Verification Date: February 2013