Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12616001713482
Ethics application status
Approved
Date submitted
30/11/2016
Date registered
14/12/2016
Date last updated
14/12/2016
Type of registration
Retrospectively registered

Titles & IDs
Public title
Randomised placebo controlled trial of inhaled corticosteroids for treatment of chronic cough in children.
Scientific title
Is a two week course of inhaled corticosteroids efficacious for reducing cough severity in children with chronic cough, compared to placebo?
Secondary ID [1] 273139 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record
ACTRN12611000589987. Study investigators have decided that it is more accurate to split this registration into two separate studies based on cough duration (acute cough and chronic cough).

Health condition
Health condition(s) or problem(s) studied:
Chronic cough in children. 270893 0
Condition category
Condition code
Respiratory 279068 279068 0 0
Other respiratory disorders / diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Children will be randomised to receive either inhaled corticosteroids or placebo. Children 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] 269480 0
Treatment: Drugs
Comparator / control treatment
Children allocated to the control group will receive a placebo inhaler with no active ingredient.
Control group
Placebo

Outcomes
Primary outcome [1] 279718 0
Proportion of children with good response to inhaled corticosteroid treatment. Good response is defined as an improvement in cough verbal category descriptive score of greater than or equal to 1 for at least 3 days compared to baseline.
Timepoint [1] 279718 0
Endpoint of study medication is day 14. Cough verbal category descriptive score to be assessed daily for the 14 days of study medication. Timepoint for primary outcome is during the 14 day study treatment regime.
Secondary outcome [1] 294289 0
Proportion of participants with an improvement in parent-proxy chronic cough-specific quality of life (PC-QOL) scores.
Timepoint [1] 294289 0
Day 7 and 14.
Secondary outcome [2] 294387 0
Proportion of children with a reduction in fractional exhaled nitric oxide (FeNO).
Timepoint [2] 294387 0
Day 14.

Eligibility
Key inclusion criteria
Children with chronic cough. Chronic cough is defined as cough duration of >=4 weeks.
Minimum age
18 Months
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 adequately use 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 the emergency department or outpatient clinic and invited to participate. Following provision of written informed consent by the parent/guardian, children will be randomly allocated to either inhaled corticosteroid or placebo. Allocation will be performed by a hospital pharmacist external to the research project and concealed in sequentially numbered sealed opaque envelopes.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomisation sequence, stratified by age and using permuted blocks of variable block sizes will be generated and maintained by a statistician external to the research project. Children will be allocated the next available independent sequential study number within the appropriate age stratification (<=6 and >6 years). The allocation is fully concealed from all investigators.
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
Recruiting
Date of first participant enrolment
Anticipated
Actual
7/06/2011
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
77
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NT,QLD
Recruitment hospital [1] 7032 0
Lady Cilento Children's Hospital - South Brisbane
Recruitment hospital [2] 7033 0
Royal Darwin Hospital - Tiwi
Recruitment postcode(s) [1] 14763 0
4101 - South Brisbane
Recruitment postcode(s) [2] 14764 0
0810 - Tiwi

Funding & Sponsors
Funding source category [1] 269958 0
Hospital
Name [1] 269958 0
Children's Hospital Foundation
Country [1] 269958 0
Australia
Primary sponsor type
Individual
Name
Prof Anne Chang
Address
Department of Respiratory and Sleep Medicine
Level 5 Lady Cilento Children's Hospital
501 Stanley Street
South Brisbane QLD 4101
Country
Australia
Secondary sponsor category [1] 268955 0
None
Name [1] 268955 0
Address [1] 268955 0
Country [1] 268955 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 271927 0
Children's Health Queensland Hospital and Health Service (LCCH) Human Research Ethics Committee
Ethics committee address [1] 271927 0
Level 7 Centre for Children's Health Research
Lady Cilento Children's Hospital Precinct
62 Graham Street
South Brisbane QLD 4101
Ethics committee country [1] 271927 0
Australia
Date submitted for ethics approval [1] 271927 0
Approval date [1] 271927 0
18/01/2011
Ethics approval number [1] 271927 0
HREC/10/QRCH/108
Ethics committee name [2] 296441 0
Human Research Ethics Committee of the Northern Territory Department of Health and Menzies School of Health Research
Ethics committee address [2] 296441 0
John Mathews Building (Building 58)
Royal Darwin Hospital Campus
Rocklands Drive
Casuarina QLD 0810
Ethics committee country [2] 296441 0
Australia
Date submitted for ethics approval [2] 296441 0
11/09/2013
Approval date [2] 296441 0
12/12/2013
Ethics approval number [2] 296441 0
HOMER2013-2097

Summary
Brief summary
This study will help us answer the question: should children with chronic cough be given inhaled corticosteroids to promote faster recovery and improve ability for children to return to their normal daily routines? This study will also evaluate whether fractional exhaled nitric oxide levels can predict short term response to inhaled corticosteroids in children with chronic cough. We hypothesise that a short (two week) course of inhaled corticosteroids will reduce cough severity in children with chronic cough, and that FeNO measurements can be used to predict this response.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 33221 0
Prof Anne Chang
Address 33221 0
Department of Respiratory and Sleep Medicine
Level 5, Lady Cilento Children's Hospital
501 Stanley Street
South Brisbane QLD 4101
Country 33221 0
Australia
Phone 33221 0
+61739681111
Fax 33221 0
Email 33221 0
[email protected]
Contact person for public queries
Name 16468 0
Prof Anne Chang
Address 16468 0
Department of Respiratory and Sleep Medicine
Level 5, Lady Cilento Children's Hospital
501 Stanley Street
South Brisbane QLD 4101
Country 16468 0
Australia
Phone 16468 0
+61730681111
Fax 16468 0
Email 16468 0
[email protected]
Contact person for scientific queries
Name 7396 0
Prof Anne Chang
Address 7396 0
Department of Respiratory and Sleep Medicine
Level 5, Lady Cilento Children's Hospital
501 Stanley Street
South Brisbane QLD 4101
Country 7396 0
Australia
Phone 7396 0
+61730681111
Fax 7396 0
Email 7396 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.