Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12605000790640
Ethics application status
Approved
Date submitted
12/12/2005
Date registered
14/12/2005
Date last updated
10/12/2018
Date data sharing statement initially provided
10/12/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
Deep breaths and airway closure in asthma
Scientific title
Effect of inhaled surfactant on the magnitude of bronchoprotection by deep inspiration against methacholine induced airway narrowing in asthmatic and non-asthmatic subjects
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Asthma 950 0
Condition category
Condition code
Respiratory 1019 1019 0 0
Asthma

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Poractant alfa, 120mg delivered by aerosolization of a 50mg/ml suspension in 0.9% normal saline, on two occasions administered 30 minutes before bronchial challenge with methacholine chloride.
Intervention code [1] 797 0
None
Comparator / control treatment
Control solution is 0.9% normal saline, delivered by aerosolization on two occasions administered 30 minutes before bronchial challenge with methacholine chloride.
Control group
Placebo

Outcomes
Primary outcome [1] 1366 0
The fall in the forced expiratory volume in one second, with and without deep inspirations.
Timepoint [1] 1366 0
Measured 60 seconds after bronchial challenges with methacholine, after active and control treatments.
Secondary outcome [1] 2418 0
The bronchoprotective effect of deep inspiration, measured by the difference in response between tests with and without deep inspirations, after active and control treatments.
Timepoint [1] 2418 0

Eligibility
Key inclusion criteria
Asthma, defined by previous doctor diagnosis and current symptoms or regular therapyNon-asthmatic controls with no history of asthma or other chronic respiratory disease.
Minimum age
Not stated
Maximum age
Not stated
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Smokers and subjects who are otherwise unsuitable for bronchial challenge will be excluded.

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)
Random allocation sequence generated and kept by an independent researcher in a password protected file
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Random number generator in Microsoft Excel used to determine treatment sequence
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Crossover
Other design features
Phase
Phase 2 / Phase 3
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Withdrawn
Reason for early stopping/withdrawal
Other reasons/comments
Other reasons
Estimate - details not known
Date of first participant enrolment
Anticipated
1/02/2006
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
20
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 1121 0
Other
Name [1] 1121 0
Woolcock Institute of Medical Research
Country [1] 1121 0
Australia
Primary sponsor type
Other
Name
Woolcock Institute of Medical Research
Address
Country
Australia
Secondary sponsor category [1] 979 0
None
Name [1] 979 0
N/A
Address [1] 979 0
Country [1] 979 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 2435 0
Sydney South West Area Health Service (RPAH Zone)
Ethics committee address [1] 2435 0
Ethics committee country [1] 2435 0
Australia
Date submitted for ethics approval [1] 2435 0
Approval date [1] 2435 0
27/01/2006
Ethics approval number [1] 2435 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 35138 0
Address 35138 0
Country 35138 0
Phone 35138 0
Fax 35138 0
Email 35138 0
Contact person for public queries
Name 9986 0
Sarah Newton-John
Address 9986 0
PO Box M77
Missenden Road
Camperdown NSW 2050
Country 9986 0
Australia
Phone 9986 0
+61 2 95156578
Fax 9986 0
+61 2 95505865
Email 9986 0
sarahnj@woolcock.org.au
Contact person for scientific queries
Name 914 0
Dr Cheryl Salome
Address 914 0
Woolcock Institute of Medical Research
PO Box M77
Missenden Road
Camperdown NSW 2050
Country 914 0
Australia
Phone 914 0
+61 2 95158383
Fax 914 0
+61 2 95506115
Email 914 0
cms@woolcock.org.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No/undecided IPD sharing reason/comment


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.