Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12605000321640
Ethics application status
Approved
Date submitted
1/09/2005
Date registered
6/09/2005
Date last updated
24/11/2016
Type of registration
Prospectively registered

Titles & IDs
Public title
Asthma Management in CHildren Based on Exhaled Nitric Oxide - Randomised Controlled Trial
Scientific title
Asthma Management in Children Based on Exhaled Nitric Oxide - Randomised Controlled Trial
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Asthma 409 0
Condition category
Condition code
Respiratory 480 480 0 0
Asthma

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Adjust treatment according to exhaled nitric oxide result, monthly for 4 months, then second monthly for 8 months. Duration of study is 12 months.
Intervention code [1] 325 0
Treatment: Drugs
Comparator / control treatment
Control group
Uncontrolled

Outcomes
Primary outcome [1] 550 0
Reduced asthma exacerbations during 12 months
Timepoint [1] 550 0
Primary outcome [2] 551 0
Reduced asthma hospitalisations during 12 months
Timepoint [2] 551 0
Secondary outcome [1] 1168 0
Cough and asthma score
Timepoint [1] 1168 0
Completed daily for a duration of 12 months.
Secondary outcome [2] 1169 0
Child QOL and carer/parent QOL
Timepoint [2] 1169 0
Administered monthly for 4 months and then second monthly for 8 months.

Eligibility
Key inclusion criteria
Children with asthma attending a paediatric specialist clinic.
Minimum age
4 Years
Maximum age
Not stated
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Presence of other cardiorespiratory illness such as CF, trachemalacia, etc.Poorly compliant to treatment.Inability to take ICS or long acting beta-2-antagonists (LABA).

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)
A black sticker obscures the next treatment group and is only removed after enrolment
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Children are randomised within strata of age (<6 years or >=6 years) and site or enrolment. They are subsequently allocated to the next treatment regimen on a list, which was previously generated, in random order, at a remote site (Queensland Institute of Medical Research). The method of randomisation was permutated block design by computer generation.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



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

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
31/01/2006
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
110
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 546 0
Charities/Societies/Foundations
Name [1] 546 0
Royal Children's Hospital Foundation
Country [1] 546 0
Australia
Primary sponsor type
Hospital
Name
Royal Children's Hospital
Address
Country
Australia
Secondary sponsor category [1] 440 0
Individual
Name [1] 440 0
Anne Chang
Address [1] 440 0
Country [1] 440 0

Ethics approval
Ethics application status
Approved

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

Contacts
Principal investigator
Name 36186 0
Address 36186 0
Country 36186 0
Phone 36186 0
Fax 36186 0
Email 36186 0
Contact person for public queries
Name 9514 0
Anne Chang
Address 9514 0
Department of Respiratory Medicine
Royal Children's Hospital
Herston QLD 4029
Country 9514 0
Australia
Phone 9514 0
+61 7 36369149
Fax 9514 0
Email 9514 0
[email protected]
Contact person for scientific queries
Name 442 0
Helen Petsky
Address 442 0
Department of Respiratory Medicine
Royal Children's Hospital
Herston QLD 4029
Country 442 0
Australia
Phone 442 0
+61 7 36361684
Fax 442 0
Email 442 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.