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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT01101282




Registration number
NCT01101282
Ethics application status
Date submitted
7/04/2010
Date registered
9/04/2010
Date last updated
15/02/2013

Titles & IDs
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)?
Secondary ID [1] 0 0
(not yet specified)
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Pulmonary Disease, Chronic Obstructive 0 0
Lung Diseases, Obstructive 0 0
Condition category
Condition code
Respiratory 0 0 0 0
Chronic obstructive pulmonary disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Devices - Positive expiratory pressure (PEP) mask therapy

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


Treatment: Devices: 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).
Intervention code [1] 0 0
Treatment: Devices
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Symptom severity
Timepoint [1] 0 0
Within 48 hours of presenting to hospital (day 1)
Primary outcome [2] 0 0
Symptom severity
Timepoint [2] 0 0
At hospital discharge (up to approx. day 10)
Primary outcome [3] 0 0
Symptom severity
Timepoint [3] 0 0
8 weeks following hospital discharge
Primary outcome [4] 0 0
Symptom severity
Timepoint [4] 0 0
6 months following hospital discharge
Secondary outcome [1] 0 0
Disease-specific quality of life
Timepoint [1] 0 0
Within 48 hours of presenting to hospital (day 1)
Secondary outcome [2] 0 0
Disease-specific quality of life
Timepoint [2] 0 0
8 weeks following hospital discharge
Secondary outcome [3] 0 0
Disease-specific quality of life
Timepoint [3] 0 0
6 months following hospital discharge
Secondary outcome [4] 0 0
Need for assisted (non-invasive and/or invasive) ventilation during hospitalisation (within, and after 48 hours of presentation to hospital)
Timepoint [4] 0 0
At hospital discharge (up to approx. day 10)
Secondary outcome [5] 0 0
Hospital length of stay
Timepoint [5] 0 0
At hospital discharge (up to approx. day 10)
Secondary outcome [6] 0 0
Time to first exacerbation
Timepoint [6] 0 0
6 months following hospital discharge
Secondary outcome [7] 0 0
Time to first hospitalisation (due to respiratory illness)
Timepoint [7] 0 0
6 months following hospital discharge
Secondary outcome [8] 0 0
Number of acute exacerbations
Timepoint [8] 0 0
6 months following hospital discharge
Secondary outcome [9] 0 0
Number of hospitalisations (due to respiratory illness)
Timepoint [9] 0 0
6 months following hospital discharge
Secondary outcome [10] 0 0
Total number of hospitalised days
Timepoint [10] 0 0
6 months following hospital discharge
Secondary outcome [11] 0 0
Lung function (spirometry)
Timepoint [11] 0 0
At hospital discharge (up to approx. day 10)
Secondary outcome [12] 0 0
Lung function (spirometry)
Timepoint [12] 0 0
6 months following hospital discharge
Secondary outcome [13] 0 0
Mortality (actual, all cause)
Timepoint [13] 0 0
At hospital discharge (up to approx. day 10)
Secondary outcome [14] 0 0
Mortality (actual, all cause)
Timepoint [14] 0 0
6 months following hospital discharge
Secondary outcome [15] 0 0
Mortality (predicted)
Timepoint [15] 0 0
At hospital discharge (up to approx. day 10)
Secondary outcome [16] 0 0
Mortality (predicted)
Timepoint [16] 0 0
6 months following hospital discharge

Eligibility
Key inclusion 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)
Minimum age
No limit
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
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 design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Not applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/07/2010
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/01/2013
Sample size
Target
Accrual to date
Final
92
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
The Austin Hospital - Melbourne
Recruitment hospital [2] 0 0
The Alfred Hospital - Melbourne
Recruitment postcode(s) [1] 0 0
3084 - Melbourne
Recruitment postcode(s) [2] 0 0
3181 - Melbourne

Funding & Sponsors
Primary sponsor type
Other
Name
La Trobe University
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
The Alfred
Address [1] 0 0
Country [1] 0 0
Other collaborator category [2] 0 0
Other
Name [2] 0 0
Austin Hospital, Melbourne Australia
Address [2] 0 0
Country [2] 0 0

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/study/NCT01101282
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Christian R Osadnik, Bachelor of Physiotherapy
Address 0 0
La Trobe University
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT01101282