Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12611000589987
Ethics application status
Approved
Date submitted
6/06/2011
Date registered
7/06/2011
Date last updated
7/06/2011
Type of registration
Prospectively registered

Titles & IDs
Public title
Randomised placebo controlled trial of inhaled corticosteroids for treatment of acute and chronic cough in children.
Scientific title
Is a two week course of inhaled corticosteroids efficacious as primary treatment of cough in children, compared to standard therapy?
Secondary ID [1] 262318 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Acute and chronic cough in children. 268031 0
Condition category
Condition code
Respiratory 268160 268160 0 0
Other respiratory disorders / diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants will be randomised to receive either inhaled corticosteroids or placebo. Participants allocated to the intervention group will receive 250 micrograms fluticasone propionate twice daily for two weeks, delivered via metered dose inhaler and spacer (with or without mask, depending on age and technique).
Intervention code [1] 266720 0
Treatment: Drugs
Comparator / control treatment
Participants allocated to the control group will receive a placebo inhaler with no active ingredient.
Control group
Placebo

Outcomes
Primary outcome [1] 266908 0
Proportion of children with good response to inhaled corticosteroid treatment defined as a change of 1 in cough verbal category descriptive score from baseline to completion of study medication.
Timepoint [1] 266908 0
Cough verbal category descriptive score to be scored daily for 28 days. Endpoint of study medication is day 14.
Secondary outcome [1] 276605 0
Presence of viral infection detected from nasal swab.
Timepoint [1] 276605 0
Nasal swab to be collected at baseline, day 7, day 14 and day 28.
Secondary outcome [2] 276610 0
Difference in Cough Quality of Life scores.
Timepoint [2] 276610 0
Cough Quality of Life Questionnaire to be completed by parent (and child aged >6 years) at baseline, day 7, day 14, day 21 and day 28.

Eligibility
Key inclusion criteria
Children with acute or chronic cough.
Minimum age
2 Years
Maximum age
16 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Children who have received oral or inhaled corticosteroids in the week prior to presentation.
Children who are unable to tolerate inhaled corticosteroids or spacer.
Children with cerebral palsy or severe neuro-developmental abnormality.
Children with physician-confirmed underlying chronic respiratory illness.
Children who are immunocompromised.

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)
Potential participants will be screened upon presentation to emergency department or outpatient clinic, and invited to participate. Consenting participants will be randomly allocated to either inhaled corticosteroid or placebo. Allocation will be concealed by sealed opaque envelopes.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Permuted block randomisation, stratified by age (<=6, >6) and cough duration (acute, chronic).
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 4
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
8/06/2011
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
161
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 267204 0
Hospital
Name [1] 267204 0
Queensland Children's Medical Research Institute
Country [1] 267204 0
Australia
Primary sponsor type
Individual
Name
Prof Anne Chang
Address
Queensland Children's Respiratory Centre
Level 5 Woolworths Building
Royal Children's Hospital
Herston Road
Herston QLD 4029
Country
Australia
Secondary sponsor category [1] 266275 0
None
Name [1] 266275 0
Address [1] 266275 0
Country [1] 266275 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 269196 0
QLD Children's Health Services (RCH) Human Research Ethics Committee
Ethics committee address [1] 269196 0
Ethics committee country [1] 269196 0
Australia
Date submitted for ethics approval [1] 269196 0
Approval date [1] 269196 0
18/01/2011
Ethics approval number [1] 269196 0
HREC/10/QRCH/108

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

Contacts
Principal investigator
Name 32702 0
Address 32702 0
Country 32702 0
Phone 32702 0
Fax 32702 0
Email 32702 0
Contact person for public queries
Name 15949 0
Prof Anne Chang
Address 15949 0
Queensland Children's Respiratory Centre
Level 5 Woolworths Building
Royal Children's Hospital
Herston Road
Herston QLD 4029
Country 15949 0
Australia
Phone 15949 0
+61736368111
Fax 15949 0
Email 15949 0
anne_b_chang@health.qld.gov.au
Contact person for scientific queries
Name 6877 0
Prof Anne Chang
Address 6877 0
Queensland Children's Respiratory Centre
Level 5 Woolworths Building
Royal Children's Hospital
Herston Road
Herston QLD 4029
Country 6877 0
Australia
Phone 6877 0
+61736368111
Fax 6877 0
Email 6877 0
anne_b_chang@health.qld.gov.au

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.