Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12605000008628
Ethics application status
Approved
Date submitted
13/07/2005
Date registered
13/07/2005
Date last updated
14/09/2007
Type of registration
Retrospectively registered

Titles & IDs
Public title
The Funhaler study
Scientific title
A randomised controlled study evaluating the impact of a novel spacer, the Funhaler, on adherence and drug delivery in childhood asthma
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Childhood asthma 70 0
Condition category
Condition code
Respiratory 82 82 0 0
Asthma

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
RCT comparing adherence, drug delivery and asthma control of 2-7 year old children with asthma using a Funhaler (Infamed) over a 4 month period.
Intervention code [1] 19 0
None
Comparator / control treatment
A control spacer (Aerochamber plus) overa 4 month period.
Control group
Active

Outcomes
Primary outcome [1] 114 0
Adherence with daily preventive medication
Timepoint [1] 114 0
Secondary outcome [1] 262 0
Drug delivery
Timepoint [1] 262 0
Measured at enrolment and at the conclusion of the study using filters connected to the spacer.
Secondary outcome [2] 263 0
Asthma control judged by questionnaire data.
Timepoint [2] 263 0
At each visit and at the conclusion of the study.

Eligibility
Key inclusion criteria
Asthma, Currently on daily preventive medication.
Minimum age
2 Years
Maximum age
7 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
No exclusion criteria

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)
Randomised sealed opaque envelopes. Blocled in random alloquots
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computer generated. Blocked
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



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

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
7/05/2005
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
60
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 118 0
Charities/Societies/Foundations
Name [1] 118 0
fellowsip grant from the Thoracic Society of Australia & New Zealand
Country [1] 118 0
Primary sponsor type
Individual
Name
Scott Burgess
Address
Country
Secondary sponsor category [1] 87 0
None
Name [1] 87 0
Nil
Address [1] 87 0
Country [1] 87 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 855 0
Mater Children's Hospital
Ethics committee address [1] 855 0
Ethics committee country [1] 855 0
Australia
Date submitted for ethics approval [1] 855 0
Approval date [1] 855 0
Ethics approval number [1] 855 0

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

Contacts
Principal investigator
Name 35636 0
Address 35636 0
Country 35636 0
Phone 35636 0
Fax 35636 0
Email 35636 0
Contact person for public queries
Name 9208 0
Dr Scott Burgess
Address 9208 0
Department of Respiratory Medicine
Mater Hospital
Raymond Terrace QLD 4101
Country 9208 0
Australia
Phone 9208 0
+61 7 38408111
Fax 9208 0
+61 7 38408366
Email 9208 0
[email protected]
Contact person for scientific queries
Name 136 0
Dr Scott Burgess
Address 136 0
Department of Respiratory Medicine
Mater Hospital
Raymond Terrace QLD 4101
Country 136 0
Australia
Phone 136 0
+61 7 38408111
Fax 136 0
+61 7 38408366
Email 136 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

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

Documents added automatically
No additional documents have been identified.