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Trial registered on ANZCTR


Registration number
ACTRN12612000015842
Ethics application status
Not yet submitted
Date submitted
21/12/2011
Date registered
4/01/2012
Date last updated
4/01/2012
Type of registration
Prospectively registered

Titles & IDs
Public title
A randomised, cross-over trial of upright sitting with or without positive expiratory pressure during nebulised delivery of medication to improve the pattern of aerosol deposition in healthy participants
Scientific title
Randomised trial of positive expiratory pressure (PEP) to improve deposition in healthy participants
Secondary ID [1] 279641 0
Nil
Universal Trial Number (UTN)
U1111-1126-6036
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Healthy participants (to be compared to participants with cystic fibrosis of a similar age) 285439 0
Condition category
Condition code
Respiratory 285623 285623 0 0
Normal development and function of the respiratory system
Human Genetics and Inherited Disorders 285624 285624 0 0
Cystic fibrosis

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants will inhale 4mL technetium-99m DTPA radioaerosol in random order throughout the nebulisation period of 20 minutes for each of the regimens on two separte days: 1. Standard nebulisation period of 20 minutes, or
2. Nebulisation period of 20 minutes with the addition of a positive expiratory pressure device.
The two study days will have a minimum of 48 hours washout between them and not greater than 7 days (to ensure clinical stability).
After each nebulisation a gamma camera will perform a 20 minute deposition scan incorporating a transmission scan to outline the three-dimensional margin of the lung fields. This data will be reconstructed to determine the distribution of the deposited radioaerosol in the lungs.
Intervention code [1] 283923 0
Treatment: Other
Intervention code [2] 283924 0
Treatment: Devices
Comparator / control treatment
Nebulisation period of 20 minutes with the addition of a positive expiratory pressure device is the comparator treatment.
Standard nebulisation period of 20 minutes is the control condition.
A concurrent study (registered separately will include participants of similar age who will undertake the sme protocol and be a comparator group during analysis
Control group
Active

Outcomes
Primary outcome [1] 286182 0
The 3-dimensional map of the lung fields will be divided into unit volumes (voxels). The amount of radioactivity in each voxel will be calculated. The standard deviation of the radioactivity across all voxels within the margins of the lung fields will be used as an index of uniformity of the pattern of deposition for each participant.
Timepoint [1] 286182 0
Immediately post 20 minutes of inhalation
Secondary outcome [1] 295324 0
The ratio of central:peripheral deposition of radioactivity will be determined by the mean number of counts per voxel in the central lung field divided by the mean number of counts per voxel in peripheral the lung field.
Timepoint [1] 295324 0
Immediately post 20 minutes of inhalation
Secondary outcome [2] 295325 0
The ratio of apical:non-apical deposition of radioactivity will be determined by the mean number of counts per voxel in the apical one third of the lung field divided by the mean number of counts per voxel in the basal two thirds of the lung field.
Timepoint [2] 295325 0
Immediately post 20 minutes of inhalation
Secondary outcome [3] 295326 0
The deposition fraction will be calculated as the amount of radioactivity in the lung fields divided by the amount of radioactivity in the nebuliser before inhalation, with correction for decay.
Timepoint [3] 295326 0
Immediately post 20 minutes of inhalation

Eligibility
Key inclusion criteria
Inclusion Criteria: To participate in this study, a person must:
1 be 18 years of age or older
2 be able to read, write and comprehend English
3 have normal lung function, with greater than or equal to 80% predicted FEV1
4 be willing to inhale a 4mL radioaerosol and undergo a 20-minute gamma scan, on two occasions.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Exclusion Criteria: A person will be ineligible to participate in this study if s/he:
1 has any respiratory condition
2 has significant malignant, neurological or musculoskeletal conditions
3 is unable to perform spirometry reproducibly
4 is pregnant, or is sexually active and unwilling to use contraception during the study

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)
Potential participants will be invited to read an Information for Participants document, and sign a consent form to participate in the study. Eligibility will then be confirmed with reference to the willing participant’s spirometry in standing according to the most recent American Thoracic Society criteria Participants will then be randomised via a coin toss by a blinded investigator to regimen "1. or 2." for their first study day (but will be unaware of the accociated regimen). 1. Standard nebulisation period of 20 minutes, or
2. Nebulisation period of 20 minutes with the addition of a positive expiratory pressure device.
Participants will be requested to adopt this strategy and maintain a normal tidal breathing pattern during the subsequent standard study inhalation. When participants return for their second study day, they will adopt the other inhalation regimen.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Coin toss for the first inhalation strategy performed by a blinded investigator.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Crossover
Other design features
Nil
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/03/2012
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
15
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 284418 0
Charities/Societies/Foundations
Name [1] 284418 0
Physiotherapy Research Foundation
Country [1] 284418 0
Australia
Primary sponsor type
Hospital
Name
Royal Prince Alfred Hospital
Address
Missenden Road
Camperdown NSW 2050
Country
Australia
Secondary sponsor category [1] 283346 0
None
Name [1] 283346 0
None
Address [1] 283346 0
Country [1] 283346 0

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 286378 0
SLHD (RPA Zone)
Ethics committee address [1] 286378 0
Missenden Road
Camperdown NSW 2050
Ethics committee country [1] 286378 0
Australia
Date submitted for ethics approval [1] 286378 0
14/12/2011
Approval date [1] 286378 0
Ethics approval number [1] 286378 0
HREC/11/RPAH/646

Summary
Brief summary
Research question: To determine whether the addition of positive expiratory pressure (PEP) improves uniformity of deposition of an inhaled aerosol in upright sitting in healthy participants.

Methods: Inclusion criteria: greater than or equal to18 years of age, normal lung function. Participants will inhale a 4mL radioaerosol in two stategies in random order throughout the nebulisation period of 20 minutes:
1. Standard nebulisation period of 20 minutes, or
2. Nebulisation period of 20 minutes with the addition of a PEP device.

After each nebulisation a gamma camera will perform a 20-minute deposition scan incorporating a transmission scan to outline the three-dimensional margin of the lung fields. This data will be reconstructed to determine the distribution of the deposited radioaerosol in the lungs. A 15% improvement in uniformity of deposition is the proposed minimum difference that would make further investigation of the PEP strategy worthwhile in patient populations.

Significance of project: In many patient populations (eg, cystic fibrosis, HIV and bronchiectasis), the pattern of deposition of inhaled medication is poor and non-uniform. The ability to deliver a drug more uniformly to the lung using the addition of PEP may have a significant impact on treatment efficacy for people with lung disease. Data from healthy participants will aid interpretation of subsequent studies in patients.
Trial website
Nil
Trial related presentations / publications
Nil
Public notes

Contacts
Principal investigator
Name 33560 0
Address 33560 0
Country 33560 0
Phone 33560 0
Fax 33560 0
Email 33560 0
Contact person for public queries
Name 16807 0
Ruth Dentice
Address 16807 0
Department of Respiratory Medicine Level 11
Royal Prince Alfred Hospital
Missenden Road Camperdown NSW 2050
Country 16807 0
Australia
Phone 16807 0
61 2 95155234
Fax 16807 0
61 2 95158196
Email 16807 0
[email protected]
Contact person for scientific queries
Name 7735 0
Ruth Dentice
Address 7735 0
Department of Respiratory Medicine Level 11
Royal Prince Alfred Hospital
Missenden Road Camperdown NSW 2050
Country 7735 0
Australia
Phone 7735 0
61 2 95155234
Fax 7735 0
61 2 95158196
Email 7735 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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