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Pulmonary Disease, Chronic ObstructiveNCT01101282

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

A study testing Positive expiratory pressure (PEP) mask therapy in people with Pulmonary Disease, Chronic Obstructive and Lung Diseases, Obstructive, run by La Trobe University at 2 sites in Australia.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Any age
What is being tested?
Positive expiratory pressure (PEP) mask therapy
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
92 participants
Where
2 sitesAustralia
Study dates
Jul 2010to Jan 2013
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Any age
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

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.

Trial locations and contacts

2 sites in 1 country.

Australia2 sites

  • The Austin Hospital

    Melbourne, Victoria, 3084

  • The Alfred Hospital

    Melbourne, Victoria, 3181

Other trials in Australia

About this study

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)?

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.

Read the 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.

Being tested
Positive expiratory pressure (PEP) mask therapy
Keywords
PEP, exacerbation, physiotherapy, airway clearance, sputum, physical Therapy modalities
Medical subject headings
Pulmonary Disease, Chronic Obstructive, Lung Diseases, Obstructive

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Positive expiratory pressure (PEP) mask therapyDevice

    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 groups in NCT01101282
Study groupRoleWhat they receive
'Usual care'No interventionParticipants 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.
'Usual care' plus PEP mask therapyExperimentalThis will comprise: * 'Usual care' * PEP mask therapy
Receives: Device: Positive expiratory pressure (PEP) mask therapy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Symptom severity

    Measured via the Breathlessness, Cough and Sputum Scale (BCSS).

    Measured: Within 48 hours of presenting to hospital (day 1)

  2. Symptom severity

    Measured via the BCSS

    Measured: At hospital discharge (up to approx. day 10)

  3. Symptom severity

    Measured via the BCSS

    Measured: 8 weeks following hospital discharge

  4. Symptom severity

    Measured via the BCSS

    Measured: 6 months following hospital discharge

Secondary outcomes (16)

  1. Disease-specific quality of life

    Measured via the 4-week English (Australian) version of the St. George's Respiratory Questionnaire (SGRQ).

    Measured: Within 48 hours of presenting to hospital (day 1)

  2. Disease-specific quality of life

    Measured via the SGRQ

    Measured: 8 weeks following hospital discharge

  3. Disease-specific quality of life

    Measured via the SGRQ

    Measured: 6 months following hospital discharge

  4. Need for assisted (non-invasive and/or invasive) ventilation during hospitalisation (within, and after 48 hours of presentation to hospital)

    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.

    Measured: At hospital discharge (up to approx. day 10)

  5. Hospital length of stay

    Measured as number of days

    Measured: At hospital discharge (up to approx. day 10)

  6. Time to first exacerbation

    Measured as number of days

    Measured: 6 months following hospital discharge

  7. Time to first hospitalisation (due to respiratory illness)

    Measured as number of days

    Measured: 6 months following hospital discharge

  8. Number of acute exacerbations

    Measured as number of events

    Measured: 6 months following hospital discharge

  9. Number of hospitalisations (due to respiratory illness)

    Measured as number of events

    Measured: 6 months following hospital discharge

  10. Total number of hospitalised days

    Measured as number of hospitalised days

    Measured: 6 months following hospital discharge

  11. Lung function (spirometry)

    e.g. FEV1, FVC, FEV1/FVC%

    Measured: At hospital discharge (up to approx. day 10)

  12. Lung function (spirometry)

    e.g. FEV1, FVC, FEV1/FVC%

    Measured: 6 months following hospital discharge

  13. Mortality (actual, all cause)

    Measured as number of events

    Measured: At hospital discharge (up to approx. day 10)

  14. Mortality (actual, all cause)

    Measured as number of events

    Measured: 6 months following hospital discharge

  15. Mortality (predicted)

    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).

    Measured: At hospital discharge (up to approx. day 10)

  16. Mortality (predicted)

    Measured via BODE index

    Measured: 6 months following hospital discharge

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Apr 2010 (estimated)
  2. Study startJul 2010
  3. Primary completionJan 2013
  4. Study completionJan 2013

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
92 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01101282
Sponsor's protocol ID
(not yet specified)
Status last verified
Feb 2013
First submitted
7 Apr 2010
Last updated
15 Feb 2013
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A study testing Positive expiratory pressure (PEP) mask therapy in people with Pulmonary Disease, Chronic Obstructive and Lung Diseases, Obstructive, run by La Trobe University at 2 sites in Australia.

The full registered description is in the About this study section and the official record.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 15 Feb 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Symptom severity (time frame: Within 48 hours of presenting to hospital (day 1)). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01101282.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Feb 2013.

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