clinical trial

Found this on the clinical trials register while working. Intesting, i cant remember an announcment about this trial. Would be intersting to find out the results, it was supposed to commence in may 2005.



Title: The Funhaler study

Official scientific title A randomised controlled study evaluating the impact of a novel spacer, the Funhaler, on adherence and drug delivery in childhood asthma
Secondary IDs:

Trial acronym:
Condition: childhood asthma
Condition code: UNDEFINED

Intervention/s: RCT comparing adherence, drug delivery and asthma control of 2-7 year old children with asthma using a Funhaler (Infamed) and a control spacer (Aerochamber plus) overa 4 month period.
Intervention code: UNDEFINED
Primary Outcome: Adherence with daily preventive medication

Key Secondary outcome/s: Drug delivery measured at enrolment and at the conclusion of the study using filters connected to the spacer. Asthma control judged by questionnaire data at each visit and at the conclusion of the study.
Key inclusion and exclusion criteria: 2-7years Asthma Currently on daily preventive medication

Section 2

Study type: Interventional

Interventional Study
Purpose of the intervention: Treatment
Allocation to intervention: Randomised Controlled Trial
Allocation concealment: Randomised sealed opaque envelopes. Blocled in random alloquots
Sequence generation: Computer generated. Blocked
Masking: Open (masking not used)
Control Group: Active
Assignment: Parallel
Other design features (specify):
Endpoint: Efficacy

Observational Study
Purpose: UNDEFINED
Duration: UNDEFINED
Selection: UNDEFINED
Timing: UNDEFINED

Section 3

Phase UNDEFINED
Anticipated trial start date: 07/05/2005
Target sample size: 60
Recruitment status (at time of registration): Open To Recruitment
Funding source/s: Currently using money from a fellowsip grant from the Thoracic Society of Australia & NZ
Primary sponsor: Scott Burgess
Secondary sponsor/s: Nil
Has the study received appropriate ethics committee approval review: Yes
Site/s with ethics approval: Mater Children's Hospital, South Brisbane
Brief summary:

Responsible Contact person
Name: Dr Scott Burgess
Address: Department of Respiratory Medicine, Raymond Terrace QLD 4101 Australia
Tel: +61 7 3840 8111
Fax: +61 7 3840 8366
Email: [email protected]

Research contact person
Name: Dr Scott Burgess
Address: Department of Respiratory Medicine, Raymond Terrace QLD 4101 Australia
Tel: +61 7 3840 8111
Fax: +61 7 3840 8366
Email: [email protected]

The Registrant: Scott Burgess