Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12613000621718
Ethics application status
Not yet submitted
Date submitted
29/05/2013
Date registered
30/05/2013
Date last updated
30/05/2013
Type of registration
Prospectively registered

Titles & IDs
Public title
Comparison of three methods of sputum clearance in patients with an acute exacerbation of chronic obstructive pulmonary disease (COPD).
Scientific title
In patients with an acute exacerbation of COPD, do positive expiratory pressure (PEP) devices, compared to standard physiotherapy exercises, reduce patient reported symptoms of breathlessness, cough and sputum.
Secondary ID [1] 282591 0
None
Universal Trial Number (UTN)
1111-1142-1941
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Acute exacerbation of chronic obstructive pulmonary disease (AECOPD) 289282 0
Condition category
Condition code
Respiratory 289606 289606 0 0
Chronic obstructive pulmonary disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment arm 1. A variable resistance positive expiratory pressure (PEP) device (TheraPEP 'Registered Trademark'), it has six resistance setting with pressures ranging from 10cmH2O to 20cmH2O.

The participant will be instructed to sit upright with elbows resting on a table holding the theraPEP 'Registered Trademark' device in front of them. The participant will be instructed to seal their lips around the mouth piece and exhale with a little force for three seconds only so the blue disc rises and reaches between the lower and upper black line. They will repeat this for 10 breaths, followed by two huffs (Forced expiratory technique (FET) – a demonstration maybe helpful) and a cough.

The full set will be repeated two more times to complete each session. There will be a two minute rest between each set. The first treatment session will be supervised and participants will be instructed to complete two further unsupervised sessions, one in the afternoon and another later that night. Participants will complete a diary after each treatment session.

Participants will be shown how to and instructed to increase the resistance if they are reaching the top black line too easily as per the usual method of use.

Treatment arm 2 - Bubble-PEP is a threshold resistor PEP system constructed using a plastic bottle, 10cm water and flexible plastic tubing. Bubble-PEP to be set up with 10cm of water (line marked on the bottle), a length of suction tubing placed down the handle of a two litre new plastic bottle.

The bubble-PEP device will be set up on a table in front of the participant with the participant sitting upright. Participants will be instructed to seal their lips around the tubing and exhale with a little force for three seconds only to create bubbles. Participants will repeat this for 10 breaths, followed by two huffs (FET – a demonstration maybe helpful) and a cough.

The full set is to be repeated two more times to complete the treatment session. There will be a two minute rest between each set. Participants will be supervised for their first session and a handout given. Participants will be instructed to complete 2 further unsupervised sessions, one in the afternoon and one later that night. Participants will complete a diary after each treatment session.

The water in the bottle will be changed after each treatment session and refilled to the marked line to ensure 10cm of water as per the Counties Manukau District Health Board (CMDHB) bubble–PEP device procedure
Intervention code [1] 287259 0
Treatment: Devices
Comparator / control treatment
Treatment arm 3 -Standard physiotherapy breathing exercises (Active cycle of breathing technique (ACBT))

With participants sitting upright, they will be are instructed to take three slow deep breaths in through their nose, followed by three relaxed breaths. Three more slow deep breaths, followed by three relaxed breaths with two huffs (forced expiratory technique (FET) – a demonstration maybe helpful) and a cough.

This full set is repeated two more times to complete one treatment session. There will be a two minute rest between each set. The first treatment session will be supervised and a handout will be provided. Participants will be instructed to complete two further treatment sessions independently, one in the afternoon and another later that night. Participants will complete a diary after each treatment session.
Control group
Active

Outcomes
Primary outcome [1] 289698 0
Breathlessness, cough and sputum scale (BCSS)
Timepoint [1] 289698 0
Baseline, 30min after each treatment session on day 1(3 treatment sessions), Reassessment on day 2
Secondary outcome [1] 303045 0
Length of hospital stay
Timepoint [1] 303045 0
On discharge from this hospital admission
Secondary outcome [2] 303046 0
Ease of expectoration on visual analogue scale
Timepoint [2] 303046 0
At baseline, 30min after each treatment session on day 1 (3 sessions) and at reassessment on day 2.
Secondary outcome [3] 303047 0
Lung function specifically forced expiratory volume in 1 second (FEV1) and forced vital capacity (FVC) as measured by bedside spirometry
Timepoint [3] 303047 0
At baseline assessment, 40min after first treatment session, at reassessment on day 2.
Secondary outcome [4] 303048 0
Health-related quality of life (HRQoL) - COPD Assessment Test (CAT).
Timepoint [4] 303048 0
At baseline, 40minutes after first supervised treatment session and at reassessment on day 2.

Eligibility
Key inclusion criteria
Diagnosis of mild, moderate or severe COPD (as defined by spirometry) based on the Global Initiative for Chronic Obstructive Lung Disease (GOLD) guidelines

18 years or over.

Admitted to Middlemore Hospital medical wards.

Exacerbation with reported sputum based on GOLD definition from COPDx Guidelines (An exacerbation is an event in the natural course of the disease characterised by a change in the patient’s baseline dyspnoea, cough, and/or sputum that is beyond normal day-to-day variations, is acute in onset, and may warrant a change in regular medication in a patient with underlying COPD)

English speaking and reading

Consent to research
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Non English speaking or reading

Unable to complete questionnaires or actively participate in treatment for any other reason (medical, physical, psychological)

Any previous PEP use at home

Receiving Bilevel positive airway pressure (BiPAP) treatment (as already receiving a form of positive pressure)

Any contraindications to PEP - large bullous disease, undrained pneumothorax

Any contraindications to airway clearance techniques, namely frank haemoptysis

Any patients previously recruited into this trial on any other admission

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)
Patients admitted with an AECOPD will be identified as per standard practice from the ward handover sheets every morning and from daily ward handover meetings. Randomisation will occur (via envelopes) just after the initial assessment, after participants have been deemed eligible, consented and assessed
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computer generated randomisation codes will be allocated to the participants individual research code.
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
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
24/06/2013
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
75
Accrual to date
Final
Recruitment outside Australia
Country [1] 5120 0
New Zealand
State/province [1] 5120 0
Auckland

Funding & Sponsors
Funding source category [1] 287373 0
Hospital
Name [1] 287373 0
Counties Manukau District Health Board, Research Office, Tupu Research Fund
Country [1] 287373 0
New Zealand
Primary sponsor type
Individual
Name
Brigitte Eastwood
Address
Middlemore Hospital
Counties Manukau Health
Private Bag 93 311
Auckland 1640
Country
New Zealand
Secondary sponsor category [1] 286119 0
Individual
Name [1] 286119 0
Katie Coulter
Address [1] 286119 0
Counties Manukau Health
Private Bag 93 311
Auckland 1640
Country [1] 286119 0
New Zealand

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 289348 0
Health and Disability Ethics Committee
Ethics committee address [1] 289348 0
Ministry of Health
No 1 The Terrace
PO Box 5013
Wellington 6145
Ethics committee country [1] 289348 0
New Zealand
Date submitted for ethics approval [1] 289348 0
28/05/2013
Approval date [1] 289348 0
Ethics approval number [1] 289348 0

Summary
Brief summary
Chronic obstructive pulmonary disease (COPD) is a respiratory disorder defined by airflow limitation that is not fully reversible. Individuals diagnosed with COPD present with chronic and progressive breathlessness, cough, and often sputum production. Positive expiratory pressure (PEP) is a form of airway clearance that works by splinting the airways open on expiration and allowing greater movement of air, it has been found to be an effective form of immediate airway clearance. Commercial PEP devices are expensive; however an alternative form of PEP that is inexpensive and is being used by New Zealand and Australian physiotherapists in the treatment of COPD is bubble-PEP. Despite bubble-PEP being used regularly there is limited evidence that assesses the effectiveness of it for its use in secretion clearance in the COPD population.

The aim of the study is to assess the effect of bubble-PEP compared with theraPEP 'Registered Trademark' (a type of commercially available PEP) and standard physiotherapy in patients with an acute exacerbation of COPD (AECOPD). The study aims to determine if 1, bubble-PEP has a greater effect on participant reported symptoms of breathlessness, cough and sputum compared with standard physiotherapy; 2, bubble-PEP is comparable to theraPEP 'Registered Trademark'.

The study hypothesis is that bubble-PEP will have a greater effect on participant reported symptoms than standard physiotherapy and that bubble-PEP will be as effective as the commercial product theraPEP 'Registered Trademark'.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 40418 0
Miss Brigitte Eastwood
Address 40418 0
Counties Manukau Health
Private Bag 93311
Auckland 1640
Country 40418 0
New Zealand
Phone 40418 0
+6492760207
Fax 40418 0
Email 40418 0
[email protected]
Contact person for public queries
Name 40419 0
Miss Brigitte Eastwood
Address 40419 0
Counties Manukau Health
Private Bag 93311
Auckland 1640
Country 40419 0
New Zealand
Phone 40419 0
+6492760207
Fax 40419 0
Email 40419 0
[email protected]
Contact person for scientific queries
Name 40420 0
Miss Brigitte Eastwood
Address 40420 0
Counties Manukau Health
Private Bag 93311
Auckland 1640
Country 40420 0
New Zealand
Phone 40420 0
+6492760207
Fax 40420 0
Email 40420 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

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