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Trial registered on ANZCTR


Registration number
ACTRN12608000294358
Ethics application status
Approved
Date submitted
9/06/2008
Date registered
13/06/2008
Date last updated
13/06/2008
Type of registration
Retrospectively registered

Titles & IDs
Public title
Clinical Efficacy of the Funhaler in Children with asthma aged 2-6 Years
Scientific title
Influence of the Funhaler on drug delivery, adherence to medication and clinical outcome in 2-6 year old children with doctor diagnosed asthma
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Asthma 3246 0
Preschool wheeze 3247 0
Condition category
Condition code
Respiratory 3410 3410 0 0
Asthma

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Use of the Funhaler instead of a conventional spacer. The Funhaler is commercialy available small volume spacer with a spinning disk and whistle on the exhalatory arm. The study group will be asked to use the Funhaler instead of their conventional spacer for administering their daily inhaled steroids (they have to be on regular inhaled steroids as part of the inclusion criteria). Each participant will be followed up for one year. If any study participant should be weaned off their inhaled steroids during the course of the study( by the study doctor or by their GP), because their asthma is well controlled, they will still be followed up.
Intervention code [1] 3001 0
Treatment: Devices
Comparator / control treatment
Conventional spacer (Aerochamber Plus)
The Aerochamber is a commonly used, commercially available small volume spacer device. As part of the inclusion criteria the study participants will be using inhaled steroids. In the preschool age group inhaled steroids are mostly prescribed for daily use and administered with puffers and spacers. All subjects will be followed up for one year after randomisation.
Control group
Active

Outcomes
Primary outcome [1] 4308 0
Symptom free days as recorded by the parents or caregivers of the study participants on diary cards. Diary cards designed to record asthma symptoms the week before every study visit i.e. one week every 3 months.
Timepoint [1] 4308 0
3 monthly for one year
Symtoms recorded on diary cards filled in by parents on diary cards the week before each study visit. Study visits every 3 months.
Secondary outcome [1] 7256 0
Electronically measured adherence to prescribed medication
Timepoint [1] 7256 0
Continuously recorded by Smartinhaler(Nexus6) electronic monitoring devices that record each time that a metered dose inhaler is actuated. (data uploaded 3 monthly). Electronic adherence monitoring continuously throughout the study (one year).
Secondary outcome [2] 7257 0
Drug delivery as measured by filter dose "inhaled"
Timepoint [2] 7257 0
3 monthly for one year. Drug inhaled via the spacer onto a filter. Filter study performed at each study visit.
Secondary outcome [3] 7258 0
Drug delivery calculated in vitro using breathing recordings and breathing simulation
Timepoint [3] 7258 0
3 monthly for one year
Secondary outcome [4] 7259 0
Quality of life (Peds QL 3.0) asthma module
Timepoint [4] 7259 0
3 monthly for one year
Secondary outcome [5] 7260 0
Asthma symptoms determined by clinical questionnaire
Timepoint [5] 7260 0
3 monthly for one year
Secondary outcome [6] 7261 0
Lung function (Forced oscillation technique)
Timepoint [6] 7261 0
3 monthly for one year

Eligibility
Key inclusion criteria
Doctor dianosed asthma
Age 2-6 years
On inhaled steroid treatment
Minimum age
2 Years
Maximum age
6 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
On oral steroids past 3 months
Chronic lung disease other than asthma
Allergy to Flixotide
Known immunodeficiency

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)
All eligible participants enrolled. Randomisation done independantly by hospital pharmacy
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Block randomisation
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint(s)
Efficacy
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] 3471 0
Government body
Name [1] 3471 0
National Institute of Health
Address [1] 3471 0
National Institutes of Health
6705 Rockledge Drive, Room 2207, MSC 7987
Bethesda, MD 20892-7987 (regular USPS or USPS Express mail)
Bethesda, MD 20817 (other courier/express mail delivery)
Country [1] 3471 0
United States of America
Primary sponsor type
Government body
Name
National Institute of Health
Address
National Institutes of Health
6705 Rockledge Drive, Room 2207, MSC 7987
Bethesda, MD 20892-7987 (regular USPS or USPS Express mail)
Bethesda, MD 20817 (other courier/express mail delivery)
Country
United States of America
Secondary sponsor category [1] 3113 0
None
Name [1] 3113 0
Address [1] 3113 0
Country [1] 3113 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 5502 0
Princess Margaret Hospital for Children Ethics Committee
Ethics committee address [1] 5502 0
GPO Box D184
Perth
WA
6840
Ethics committee country [1] 5502 0
Australia
Date submitted for ethics approval [1] 5502 0
Approval date [1] 5502 0
18/12/2003
Ethics approval number [1] 5502 0
933/EP

Summary
Brief summary
To determine whether use of the Funhaler,as a spacer for administation of asthma preventive treatment, has an influence on adherence to medication, drug delivery, and eventually if its use can improve asthma control.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 28657 0
Address 28657 0
Country 28657 0
Phone 28657 0
Fax 28657 0
Email 28657 0
Contact person for public queries
Name 11814 0
André Schultz
Address 11814 0
Princess Margaret Hospital for Chidlren
GPO Box D184
Perth
WA
6840
Country 11814 0
Australia
Phone 11814 0
08 9340 8222
Fax 11814 0
08 9340 8092
Email 11814 0
andre.schultz@health.wa.gov.au
Contact person for scientific queries
Name 2742 0
André Schultz
Address 2742 0
Princess Margaret Hospital for Chidlren
GPO Box D184
Perth
WA
6840
Country 2742 0
Australia
Phone 2742 0
08 9340 8222
Fax 2742 0
08 9340 8092
Email 2742 0
andre.schultz@health.wa.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