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Trial registered on ANZCTR
Registration number
ACTRN12625000757415
Ethics application status
Approved
Date submitted
13/06/2025
Date registered
17/07/2025
Date last updated
17/07/2025
Date data sharing statement initially provided
17/07/2025
Type of registration
Prospectively registered
Titles & IDs
Public title
Effect of Small Particle Size Bronchodilator Aerosol on Small Airway Function in Asthma
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Scientific title
Targeting peripheral airway dysfunction with small particle bronchodilator in adults with asthma
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Secondary ID [1]
314632
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None
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Asthma
337796
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Condition category
Condition code
Respiratory
334143
334143
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0
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Asthma
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Study design
This is a cross-over study. All subjects will receive both small and large particle bronchodilator, thereby serving as their own control. They will attend for 2 visits. 1x small particle visit and 1 x large particle visit. Consecutive participants will alternate between small particle first / large particle second and large particle first / small particle second, so that the order will be split equally amongst the cohort. Baseline physiology and response to both large and small particle bronchodilator will be assessed for each participant.
Bronchodilator administration
Bronchodilators act on receptors in the airway to relax the smooth muscle, increasing the airway lumen diameter, and reducing airflow obstruction. Short acting beta-2 agonists (SABA) are fast acting bronchodilators and are used as ‘rescue medication’ on presentation of asthma symptoms.
Currently there are many devices that can be used to administer SABA, which deliver particles of different sizes, but there is no consensus on which provides the most therapeutic benefit.
Up to a 100µg dose of salbutamol (equivalent of 1 actuation from a metered dose inhaler) will be delivered to the participant in the sitting position from a Aerogen Solo that will deliver the large aerosol and Aerogen PDAP nebuliser that will deliver fine aerosol (intervention).
Both the Solo and PDAP are attached to a mouthpiece, through which the participant will inhale the aerosol. They will breath normally until all of the aerosol has been delivered, this will be 1 day apart. Efficacious period for SABA / salbutamol is 4 hours, therefore 1 day is sufficient for washout.
Study setting
The study site is the Alfred Hospital. The Alfred Hospital is a large, tertiary academic hospital located in Melbourne, Australia, and is part of Alfred Health. Recruitment will be via the Asthma clinic, patients under the management of the Asthma clinic may be invited in person or over the phone to take part. Participant testing and data storage will be onsite at the Alfred hospital.
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Intervention code [1]
331271
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Treatment: Devices
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Comparator / control treatment
Intervention = small particle bronchodilator delivered by specialist nebuliser (Aeroegen PDAP)
Comparator = standard size particle bronchodilator delivered by over the counter nebuliser (Aerogen Solo)
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Control group
Active
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Outcomes
Primary outcome [1]
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Airflow obstruction
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Assessment method [1]
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Spirometry assesses levels of airflow obstruction. In asthma when bronchoconstriction (contraction of airway smooth muscle) is present the airway is narrowed to a significant degree, this can be detected with spirometry. Parameter: delta FEV1 (baseline vs post bronchodilator).
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Timepoint [1]
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Assessment will be at the end of each visit after medication delivery.
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Primary outcome [2]
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Airflow obstruction
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Assessment method [2]
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Spirometry assesses levels of airflow obstruction. In asthma when bronchoconstriction (contraction of airway smooth muscle) is present the airway is narrowed to a significant degree, this can be detected with spirometry. Parameter: delta FEV1/FVC (baseline vs post bronchodilator)
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Timepoint [2]
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Assessment will be at the end of each visit after medication delivery.
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Primary outcome [3]
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Airflow obstruction
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Assessment method [3]
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Spirometry assesses levels of airflow obstruction. In asthma when bronchoconstriction (contraction of airway smooth muscle) is present the airway is narrowed to a significant degree, this can be detected with spirometry. Parameter: delta FVC (baseline vs post bronchodilator)
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Timepoint [3]
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Assessment will be at the end of each visit after medication delivery.
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Secondary outcome [1]
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**Additional primary outcome** Global Ventilation heterogeneity
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Assessment method [1]
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MBW produces measurements of gas mixing in the central airways and the peripheral airways, and details ventilation heterogeneity. Increased ventilation heterogeneity indicates worse asthma. This test will allow patients to be stratified into peripheral and central phenotypes, as well as quantifying ventilation heterogeneity post bronchodilator. Parameter: delta LCI (lung clearance index) (baseline vs post bronchodilator).
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Timepoint [1]
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Assessment will be at the end of each visit after medication delivery.
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Secondary outcome [2]
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**Additional primary outcome** Respiratory mechanics
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Assessment method [2]
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The FOT provides measurements of respiratory mechanics, including resistance. FOT indices will be able to quantify the level of airways resistance. Parameter: delta Rrs 5Hz (respiratory resistance at 5Hertz) (baseline vs post bronchodilator).
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Timepoint [2]
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Assessment will be at the end of each visit after medication delivery.
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Secondary outcome [3]
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**Additional primary outcome** Respiratory mechanics
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Assessment method [3]
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The FOT provides measurements of respiratory mechanics, including reactance. FOT indices will be able to quantify the level of respiratory system reactance. Parameter: delta Xrs 5Hz (respiratory reactance at 5Hertz) (baseline vs post bronchodilator).
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Timepoint [3]
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Assessment will be at the end of each visit after medication delivery.
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Secondary outcome [4]
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Ventilation defect percentage (VDP)
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Assessment method [4]
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4D fluoroscopy ventilation scans. This test uses a standard fluoroscopy scan of the chest. Fluoroscopic images of a single tidal breath will be obtained at five distinct angles with the participant in a supine position. The scan time is about 30 seconds to allow for one respiratory cycle to be captured at each angle. 4DMedical’s XV Ventilation Analysis software is applied to images to quantify lung ventilation heterogeneity and generate a regional spatial map of lung ventilation and quantitative measures such as ventilation defect percent and ventilation heterogeneity. Parameter: delta VDP (baseline vs post bronchodilator).
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Timepoint [4]
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Assessment will be at the end of each visit after medication delivery.
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Secondary outcome [5]
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Spatial Ventilation heterogeneity
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Assessment method [5]
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4D fluoroscopy ventilation scans. This test uses a standard fluoroscopy scan of the chest. Fluoroscopic images of a single tidal breath will be obtained at five distinct angles with the participant in a supine position. The scan time is about 30 seconds to allow for one respiratory cycle to be captured at each angle. 4DMedical’s XV Ventilation Analysis software is applied to images to quantify lung ventilation heterogeneity and generate a regional spatial map of lung ventilation and quantitative measures such as ventilation defect percent and ventilation heterogeneity (VH). Parameter: delta VH (baseline vs post bronchodilator).
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Timepoint [5]
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Assessment will be at the end of each visit after medication delivery.
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Eligibility
Key inclusion criteria
• Able to provide informed consent to participate in the study
• Physician diagnosis of asthma
• Evidence of airway dysfunction / suboptimal Asthma control defined as either: recent positive response to salbutamol on spirometry bronchodilator testing (within 6 weeks) or an Asthma Control Questionnaire (ACQ) score >1.5.
• 18–60 years of age
• Current Non-smokers with <10-year pack history and no smoking for 12 months
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
• COPD, bronchiectasis, and any other lung disease apart from asthma based on clinical grounds and available HRCT scans
• Asthma exacerbation (increase in asthma symptoms >2days resulting in increased SABA +/- ICS or oral steroids) within the previous 6 weeks
• Attending emergency department or GP for worsening asthma symptoms in the last 12 weeks
• Current smoking (>1 cigarette/day>3months) within the last 12 months, or >10 pack year history of smoking.
• Pregnant or breastfeeding
• Unable to provide written informed consent
• Allergy to salbutamol
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Non-randomised trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Crossover
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Other design features
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Phase
Not Applicable
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Type of endpoint/s
Efficacy
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Statistical methods / analysis
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Recruitment
Recruitment status
Not yet recruiting
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Date of first participant enrolment
Anticipated
21/07/2025
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Actual
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Date of last participant enrolment
Anticipated
1/12/2025
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Actual
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Date of last data collection
Anticipated
29/12/2025
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Actual
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Sample size
Target
30
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
VIC
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Funding & Sponsors
Funding source category [1]
319193
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Commercial sector/Industry
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Name [1]
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Chiesi
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Address [1]
319193
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Country [1]
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Australia
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Primary sponsor type
Government body
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Name
Alfred Health
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Address
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Country
Australia
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Secondary sponsor category [1]
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None
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Name [1]
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Address [1]
321660
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Country [1]
321660
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
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Alfred Hospital Ethics Committee
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Ethics committee address [1]
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https://www.alfredhealth.org.au/research/ethics-research-governance
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Ethics committee country [1]
317775
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Australia
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Date submitted for ethics approval [1]
317775
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19/02/2025
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Approval date [1]
317775
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03/04/2025
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Ethics approval number [1]
317775
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41/25
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Summary
Brief summary
Targeting peripheral airway dysfunction with small particle bronchodilator in asthma This study aims to determine whether the small airways, a site of physiological dysfunction in asthma, can be targeted with bronchodilator therapy, by using a small particle size aerosol that reaches the lung periphery. Current clinical management of patients with asthma includes an array of inhaled therapies. However, there is no consensus relating to the efficacy of different particle sizes for inhalation, despite particle size being the main determinant of where the drug deposits in the airway. Participants with asthma will be invited to participate in two study visits. Both study visits will involve physiological assessments (lung function tests) and ventilation scans completed at baseline and post-bronchodilator. At one visit the standard medication salbutamol will be administered via a conventional vibrating mesh nebuliser (Aerogen solo), at the other visit the salbutamol will be administered via the Aerogen PDAP which will create a fine particle aerosol. The aim is 2 recruit and test 30 participants and compare their response to small and large particle bronchodilator.
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Trial website
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Dr Andrew Gillman
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Address
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Respiratory Medicine, Alfred Health, 55 Commercial Rd, Prahran, 3004, VIC
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Country
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Australia
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Phone
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+61 407339127
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Fax
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Email
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[email protected]
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Contact person for public queries
Name
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Claire O'Sullivan
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Address
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Lung Function, Alfred Health, 55 Commercial Rd, Prahran, 3004, VIC
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Country
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Australia
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Phone
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+61 03 9076 3476
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Fax
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Email
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[email protected]
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Contact person for scientific queries
Name
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Claire O'Sullivan
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Address
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Lung Function, Alfred Health, 55 Commercial Rd, Prahran, 3004, VIC
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Country
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Australia
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Phone
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+61 03 9076 3476
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Fax
142108
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Email
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[email protected]
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Data sharing statement
Will the study consider sharing individual participant data?
No
No IPD sharing reason/comment:
Data storage and sharing has already been outlined in the submission to ethics and in the PICF. At request an amendment may be submitted to allow for further data sharing.
What supporting documents are/will be available?
No Supporting Document Provided
Type
Citation
Link
Email
Other Details
Attachment
Study protocol
PROPOSAL_V1.0_30.01.25.pdf
Informed consent form
PICF_V2.2_17.04.25_clean.docx
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.
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