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

• Register: ClinicalTrials.gov
• Last refreshed on: 18 February 2013
• Main ID: NCT01101282
• Date of registration: 07/04/2010
• Primary sponsor: La Trobe University
• Public title: Does Positive Expiratory Pressure Mask Therapy Improve Recovery From Acute Exacerbations of Chronic Obstructive Pulmonary Disease?
• Scientific 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)?
• Date of first enrolment: July 2010
• Target sample size: 92
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT01101282
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Countries of recruitment

Australia

Contacts

• Name: Christian R Osadnik, Bachelor of Physiotherapy
• Affiliation: La Trobe University

Key inclusion & exclusion 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.



Age minimum: N/A
Age maximum: N/A
Gender: Both

Health Condition(s) or Problem(s) studied

Lung Diseases, Obstructive

Pulmonary Disease, Chronic Obstructive

Intervention(s)

Device: Positive expiratory pressure (PEP) mask therapy

Primary Outcome(s)

Symptom severity [Time Frame: 6 months following hospital discharge]

Symptom severity [Time Frame: 8 weeks following hospital discharge]

Symptom severity [Time Frame: At hospital discharge (up to approx. day 10)]

Symptom severity [Time Frame: Within 48 hours of presenting to hospital (day 1)]

Secondary Outcome(s)

Disease-specific quality of life [Time Frame: 6 months following hospital discharge]

Disease-specific quality of life [Time Frame: 8 weeks following hospital discharge]

Disease-specific quality of life [Time Frame: Within 48 hours of presenting to hospital (day 1)]

Hospital length of stay [Time Frame: At hospital discharge (up to approx. day 10)]

Lung function (spirometry) [Time Frame: 6 months following hospital discharge]

Lung function (spirometry) [Time Frame: At hospital discharge (up to approx. day 10)]

Mortality (actual, all cause) [Time Frame: 6 months following hospital discharge]

Mortality (actual, all cause) [Time Frame: At hospital discharge (up to approx. day 10)]

Mortality (predicted) [Time Frame: 6 months following hospital discharge]

Mortality (predicted) [Time Frame: At hospital discharge (up to approx. day 10)]

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)]

Number of acute exacerbations [Time Frame: 6 months following hospital discharge]

Number of hospitalisations (due to respiratory illness) [Time Frame: 6 months following hospital discharge]

Time to first exacerbation [Time Frame: 6 months following hospital discharge]

Time to first hospitalisation (due to respiratory illness) [Time Frame: 6 months following hospital discharge]

Total number of hospitalised days [Time Frame: 6 months following hospital discharge]

Secondary ID(s)

(not yet specified)

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Austin Hospital, Melbourne Australia

The Alfred