Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12607000511437
Ethics application status
Approved
Date submitted
3/10/2007
Date registered
8/10/2007
Date last updated
24/11/2016
Type of registration
Retrospectively registered

Titles & IDs
Public title
Cough and Exertion: Relationship to exhaled nitric oxide and asthma in children.
Scientific title
Cough and Exertion: Relationship to exhaled nitric oxide and asthma in children
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cough 2418 0
Asthma 2419 0
Condition category
Condition code
Respiratory 2525 2525 0 0
Other respiratory disorders / diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Randomised to either exercise challenge as per American Thoracic Society guidelines on first day or inhaled dry powder mannitol challenge (potentially 635mg). Second day the challenge not undertaken on day 1 will be undertaken, ie. cross-over design.
The testing is completed over 2 consecutive days, however a diary card is completed over a 28 day period, 4 days prior to testing and a further 24 days post testing.
Intervention code [1] 2142 0
Diagnosis / Prognosis
Comparator / control treatment
Healthy controls will undertake the same protocol as children with cough, ie. 2 consecutive days of testing.
Control group
Active

Outcomes
Primary outcome [1] 3424 0
Cough frequency per 15 minutes intervals
Timepoint [1] 3424 0
15 minutely intervals for total duration of 24 hours
Secondary outcome [1] 5684 0
Corelation between cough frequency according to clinical diagnosis and exhaled nitric oxide
Timepoint [1] 5684 0
24 hour

Eligibility
Key inclusion criteria
Children aged >6 years with a cough (either inpatients or outpatients)
Controls: Well children >6 years without cough.
Minimum age
6 Years
Maximum age
18 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Children unable to perform exercise test or breathing test

Study design
Purpose of the study
Diagnosis
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 once enrolled.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Children are randomised within strata of "children with cough" or "healthy controls".
They are subsequently allocated to the next number and sequence of testing on a list, which was previously generated, in random order, at a remote site. 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
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
27/04/2006
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
100
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 2673 0
Charities/Societies/Foundations
Name [1] 2673 0
Asthma Foundation of Queensland
Country [1] 2673 0
Australia
Primary sponsor type
Individual
Name
Helen Petsky
Address
Department of Respiratory Medicine
Royal Children's Hospital
Herston Rd
HERSTON 4029
Country
Australia
Secondary sponsor category [1] 2415 0
Individual
Name [1] 2415 0
Prof Anne Chang
Address [1] 2415 0
Department of Respiratory Medicine
Roayl Childern's Hospital
Herston Rd
HERSTON 4029
Country [1] 2415 0
Australia
Other collaborator category [1] 65 0
Individual
Name [1] 65 0
Prof Anne Chang
Address [1] 65 0
Department of Respiratory Medicine
Royal Children's Hospital
Herston Rd
HERSTON 4029
Country [1] 65 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 4592 0
Royal Children's Hospital Ethics Committee
Ethics committee address [1] 4592 0
Level 3 Foundation Building
Royal Children's Hospital
Herston Rd
HERSTON 4029
Ethics committee country [1] 4592 0
Australia
Date submitted for ethics approval [1] 4592 0
Approval date [1] 4592 0
13/02/2006
Ethics approval number [1] 4592 0

Summary
Brief summary
Exercise is used to make a diagnosis of exercise induced bronchoconstriction (narrowing of the airways) in children and adults with a history of breathlessness during or after exertion.

We are aiming to find out how much change in exhaled nitric oxide occurs after exercise and whether the amount of exhaled nitric oxide is related to exercise induced cough.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 28086 0
Address 28086 0
Country 28086 0
Phone 28086 0
Fax 28086 0
Email 28086 0
Contact person for public queries
Name 11243 0
Helen Petsky
Address 11243 0
Department of Respiratory Medicine
Level 3 Woolworths Building
Royal Children's hospital
Herston Rd
HERSTON 4029
Country 11243 0
Australia
Phone 11243 0
61-7-3636 1684
Fax 11243 0
Email 11243 0
[email protected]
Contact person for scientific queries
Name 2171 0
Prof Anne Chang
Address 2171 0
Department of Respiratory Medicine
Herston Rd
HERSTON 4029
Country 2171 0
Australia
Phone 2171 0
61-7-3636 9149
Fax 2171 0
Email 2171 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.