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Trial registered on ANZCTR


Registration number
ACTRN12611000672954
Ethics application status
Approved
Date submitted
29/04/2011
Date registered
4/07/2011
Date last updated
4/07/2011
Type of registration
Retrospectively registered

Titles & IDs
Public title
A randomised, cross-over trial of upright sitting versus alternate side lying during nebulised delivery of medication to improve the pattern of aerosol deposition in participants with cystic fibrosis
Scientific title
A randomised, cross-over trial of upright sitting versus alternate side lying during nebulised delivery of medication to improve the pattern of aerosol deposition in participants with cystic fibrosis
Secondary ID [1] 260081 0
Nil
Universal Trial Number (UTN)
U1111-1121-1029
Trial acronym
Nil
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cystic Fibrosis 268221 0
Condition category
Condition code
Human Genetics and Inherited Disorders 265900 265900 0 0
Cystic fibrosis

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants will inhale 4mL technetium-99m DTPA radioaerosol in two positions in random order throughout the nebulisation period of 20 minutes for each of the positioning regimens on two separte days: 1. Upright sitting: or 2. Alternate Side Lying: (alternated between left and right at each minute)
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 2 minute 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 the alternate side lying strategy worthwhile in CF patient populations.
Intervention code [1] 264497 0
Treatment: Other
Intervention code [2] 266893 0
Treatment: Devices
Comparator / control treatment
Upright Sitting is the control condition. Alternate side lying the experimental
Control group
Active

Outcomes
Primary outcome [1] 266662 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] 266662 0
Immediately post 20 minutes of inhalation on each of two study days
Secondary outcome [1] 276154 0
Proportion of the loaded dose (dose loaded in nebuliser - residual remining in nebuliser post 20 minutes of inhalation in MBq) delivered to the body (decay corrected gamma camera body image dose in MBq).
Timepoint [1] 276154 0
Immediately post 20 minutes of inhalation on each of two study days
Secondary outcome [2] 276155 0
The proportion of the delivered dose (dose loaded in nebuliser - residual remining in nebuliser post 20 minutes of inhalation in MBq) that deposited in the lungs. (decay corrected lung gamma camera image dose in MBq).
Timepoint [2] 276155 0
Immediately post 20 minutes of inhalation on each of two study days
Secondary outcome [3] 276156 0
The concentration of the dose in the apical regions compared to the concentration for the whole lung. 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 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 [3] 276156 0
Immediately post 20 minutes of inhalation on each of two study days

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 cystic fibrosis, diagnosed by sweat test or genotyping
4 have an FEV1 within 10% of the best recorded value as an outpatient during the previous 6 months
5 be willing to inhale a 4mL radioaerosol and undergo a 20min gamma scan, on two occasions.
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion Criteria: A person will be ineligible to participate in this study if s/he:
1 has significant malignant, neurological or musculoskeletal comorbidity, according to clinic records
2 has hepatomegaly, hepatosplenomegaly, or intestinal obstruction, according to clinic records
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)
Willing participants will then be requested to sign a consent form to participate in the study, which will be co-signed by an independent witness. Eligibility will then be confirmed with reference to the willing participant’s clinic records. Once enrolled in the trial, each participant will be invited to attend the Department of Nuclear Medicine on two days separated by a washout day. Participants will then be randomised, by flipping a coin, to one of two positions:
1. Upright sitting: to be maintained throughout the nebulisation period of 20 minutes, or
2. Alternate Side Lying: to be alternated between left and right at each minute during the nebulisation period of 20 minutes.
Participants will be requested to adopt this position 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 positioning regimen.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomised, by flipping a coin, to one of two positions for the first day. The other position performed on the second day
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Crossover
Other design features
During the sidelying day the side of commencement will be determined by flipping a coin
Phase
Not Applicable
Type of endpoint(s)
Bio-availability
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 264976 0
Charities/Societies/Foundations
Name [1] 264976 0
Physiotherapy Research Fuondation
Address [1] 264976 0
Level 1, 1175 Toorak Road, Camberwell VIC 3124
Postal Address: PO Box 437, Hawthorn BC VIC 3122
Country [1] 264976 0
Australia
Primary sponsor type
Hospital
Name
Royal Prince Alfred Hospital Sydney
Address
RPAH Missenden Road Camperdown NSW 2050
Country
Australia
Secondary sponsor category [1] 264066 0
None
Name [1] 264066 0
Address [1] 264066 0
Country [1] 264066 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 266935 0
SSWAHS (RPA Zone)
Ethics committee address [1] 266935 0
Level 3, Building 92
RPAH Missenden Road Camperdown NSW 2050
Ethics committee country [1] 266935 0
Australia
Date submitted for ethics approval [1] 266935 0
Approval date [1] 266935 0
03/03/2009
Ethics approval number [1] 266935 0
Protocol No X09-0018 & HREC/09/RPAH/27

Summary
Brief summary
Research question: To determine whether alternate side lying improves uniformity of deposition of an inhaled aerosol compared to upright sitting in participants with cystic fibrosis (CF).

Methods: Inclusion criteria: greater than or equal to 18 years of age, confirmed CF, stable lung function.
Participants will inhale a 4mL radioaerosol in two positions in random order throughout the nebulisation period of 20 minutes: 1. Upright sitting: or
2. Alternate Side Lying: (alternated between left and right at each minute)
After each nebulisation a gamma camera will perform a 20 minute deposition scan incorporating a 2 minute 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 the alternate side lying strategy worthwhile in CF patient populations.

Significance of project: In many patient populations (for example, cystic fibrosis, HIV, asthma and bronchiectasis), the pattern of deposition of inhaled medication is poor and non-uniform. Typically the upper lobes receive a reduced dose compared to the rest of the lung. The ability to deliver a drug more uniformly to the lung using the simple strategy of side lying may have a significant impact on treatment efficacy, acceptability and compliance for people with lung disease.
Trial website
Nil
Trial related presentations / publications
Nil
Public notes

Contacts
Principal investigator
Name 32549 0
Address 32549 0
Country 32549 0
Phone 32549 0
Fax 32549 0
Email 32549 0
Contact person for public queries
Name 15796 0
Ruth Dentice
Address 15796 0
Department of Respiratory Medicine Level 11
Royal Prince Alfred Hospital
Missenden Road
Camperdown NSW 2050
Country 15796 0
Australia
Phone 15796 0
61 2 95155234
Fax 15796 0
61 2 9515 8196
Email 15796 0
ruth.dentice@sswahs.nsw.gov.au
Contact person for scientific queries
Name 6724 0
Ruth Dentice
Address 6724 0
Department of Respiratory Medicine Level 11
Royal Prince Alfred Hospital
Missenden Road
Camperdown NSW 2050
Country 6724 0
Australia
Phone 6724 0
61 2 95155234
Fax 6724 0
61 2 9515 8196
Email 6724 0
ruth.dentice@sswahs.nsw.gov.au

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary