Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12614001233617
Ethics application status
Approved
Date submitted
12/11/2014
Date registered
25/11/2014
Date last updated
13/02/2017
Type of registration
Prospectively registered

Titles & IDs
Public title
Does the bubble­-positive expiratory pressure (PEP) device improve secretion clearance compared to the active cycle of breathing technique (ACBT) or no intervention (control) in people with non­-cystic fibrosis bronchiectasis?
Scientific title
Does the bubble­-positive expiratory pressure (PEP) device improve secretion clearance compared to the active cycle of breathing technique (ACBT) or no intervention (control) in people with non­-cystic fibrosis bronchiectasis?
Secondary ID [1] 285650 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Non-cystic fibrosis bronchiectasis 293496 0
Condition category
Condition code
Respiratory 293775 293775 0 0
Other respiratory disorders / diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Bubble-positive expiratory pressure (PEP) device:
Administered: Mouth-piece PEP device.
Pressure of 10-20cm H2O.
1 cycle = 3-4 deep breaths followed by 10 repetitions of blowing into the Bubble-PEP device and then 2 huffs and coughs. Repetitive cycles for a total intervention time of 30 minutes (with rest periods as needed).

Adherence will be monitored by the physiotherapist delivering the intervention.
Intervention code [1] 290593 0
Treatment: Devices
Comparator / control treatment
Comparators - ACBT or no intervention
Active cycle of breathing technique (ACBT) is a self-administered breathing technique consisting of a cycle of controlled breathing, deep breathing, huffs and coughs.
Dose/intensity used: N/A.
Repetitive cycles of the ACBT for a a total intervention time of 30 minutes (with rest periods as needed).

Adherence will be monitored by the physiotherapist delivering the intervention.
Control group
Active

Outcomes
Primary outcome [1] 293571 0
Weight of sputum as measured by calibrated scales.
Timepoint [1] 293571 0
During 30 minutes of intervention and 60 minutes post intervention.
Secondary outcome [1] 311391 0
To evaluate the acceptability and perceived benefits of the bubble­PEP device by participants immediately post intervention. This will be measured by a 5 point Likert scale.
Timepoint [1] 311391 0
Immediately Post intervention

Eligibility
Key inclusion criteria
- Confirmed diagnosis of bronchiectasis on CT
­- Reported daily sputum production
­- Ability to perform airway clearance techniques
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Primary diagnosis of CF, asthma, COPD
- Any contraindications to use of PEP e.g. severe haemoptysis, pneumothorax, recent AMI, exacerbation in the previous 4 weeks
- Inability to consent or understand English
- Cognitive impairment (MMSE<24)

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
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
5/01/2015
Actual
9/04/2015
Date of last participant enrolment
Anticipated
Actual
9/12/2016
Date of last data collection
Anticipated
Actual
16/12/2016
Sample size
Target
39
Accrual to date
Final
35
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 290236 0
Hospital
Name [1] 290236 0
Prince of Wales Hospital
Country [1] 290236 0
Australia
Primary sponsor type
Hospital
Name
Prince of Wales Hospital
Address
61 High Street, Randwick, NSW, 2031
Country
Australia
Secondary sponsor category [1] 288943 0
University
Name [1] 288943 0
University of Sydney
Address [1] 288943 0
Faculty of Health Sciences
Cumberland Campus C42
The University of Sydney
PO Box 170
Lidcombe NSW 1825
AUSTRALIA
Country [1] 288943 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 291939 0
SESLHD Human Research Ethics Committee
Ethics committee address [1] 291939 0
Ethics committee country [1] 291939 0
Date submitted for ethics approval [1] 291939 0
Approval date [1] 291939 0
07/11/2014
Ethics approval number [1] 291939 0

Summary
Brief summary
The primary aim of this study is to determine the effectiveness of bubble­-PEP device compared to the active cycle of breathing technique (ACBT) or no intervention in clearing secretions in people with non­-CF bronchiectasis. The hypothesis is that the bubble­PEP is not inferior to the ACBT and is superior to no intervention in clearing secretions. Secondary aims will be to evaluate the acceptability and perceived benefits of the bubble­PEP device by participants.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 52730 0
Ms Mary Santos
Address 52730 0
Prince of Wales Hospital, Physiotherapy Department, 61 High Street, Randwick, NSW, 2031
Country 52730 0
Australia
Phone 52730 0
+610293822671
Fax 52730 0
Email 52730 0
mary.santos@sesiahs.health.nsw.gov.au
Contact person for public queries
Name 52731 0
Miss Mary Santos
Address 52731 0
Prince of Wales Hospital, Physiotherapy Department, 61 High Street, Randwick, NSW, 2031
Country 52731 0
Australia
Phone 52731 0
+610293822671
Fax 52731 0
Email 52731 0
mary.santos@sesiahs.health.nsw.gov.au
Contact person for scientific queries
Name 52732 0
Ms Mary Santos
Address 52732 0
Prince of Wales Hospital, Physiotherapy Department, 61 High Street, Randwick, NSW, 2031
Country 52732 0
Australia
Phone 52732 0
+610293822671
Fax 52732 0
Email 52732 0
mary.santos@sesiahs.health.nsw.gov.au

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

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.