Clinical trial NCT01101282: 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)?
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pulmonary Disease, Chronic Obstructive
Lung Diseases, Obstructive
Keywords: PEP
exacerbation
physiotherapy
airway clearance
sputum
physical Therapy modalities
Lead sponsor: La Trobe University
Sponsor class: OTHER
Collaborators: name: The Alfred
name: Austin Hospital, Melbourne Australia
First posted: 2010-04-09
Enrollment: 92
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Symptom severity
timeFrame: Within 48 hours of presenting to hospital (day 1)
measure: Symptom severity
timeFrame: At hospital discharge (up to approx. day 10)
measure: Symptom severity
timeFrame: 8 weeks following hospital discharge
measure: Symptom severity
timeFrame: 6 months following hospital discharge
Secondary outcomes:
measure: Disease-specific quality of life
timeFrame: Within 48 hours of presenting to hospital (day 1)
measure: Disease-specific quality of life
timeFrame: 8 weeks following hospital discharge
measure: Disease-specific quality of life
timeFrame: 6 months following hospital discharge
measure: Need for assisted (non-invasive and/or invasive) ventilation during hospitalisation (within, and after 48 hours of presentation to hospital)
timeFrame: At hospital discharge (up to approx. day 10)
measure: Hospital length of stay
timeFrame: At hospital discharge (up to approx. day 10)
measure: Time to first exacerbation
timeFrame: 6 months following hospital discharge
measure: Time to first hospitalisation (due to respiratory illness)
timeFrame: 6 months following hospital discharge
measure: Number of acute exacerbations
timeFrame: 6 months following hospital discharge
measure: Number of hospitalisations (due to respiratory illness)
timeFrame: 6 months following hospital discharge
measure: Total number of hospitalised days
timeFrame: 6 months following hospital discharge
measure: Lung function (spirometry)
timeFrame: At hospital discharge (up to approx. day 10)
measure: Lung function (spirometry)
timeFrame: 6 months following hospital discharge
measure: Mortality (actual, all cause)
timeFrame: At hospital discharge (up to approx. day 10)
measure: Mortality (actual, all cause)
timeFrame: 6 months following hospital discharge
measure: Mortality (predicted)
timeFrame: At hospital discharge (up to approx. day 10)
measure: Mortality (predicted)
timeFrame: 6 months following hospital discharge
Other outcomes:
Locations:
city: Melbourne
country: Australia
facility: The Austin Hospital
state: Victoria
city: Melbourne
country: Australia
facility: The Alfred Hospital
state: Victoria
Study officials:
affiliation: La Trobe University
name: Christian R Osadnik, Bachelor of Physiotherapy
role: PRINCIPAL_INVESTIGATOR
References: