Randomised placebo controlled trial of inhaled corticosteroids for treatment of chronic cough in children.
Phase 4
Recruiting
- Conditions
- Chronic cough in children.Respiratory - Other respiratory disorders / diseases
- Registration Number
- ACTRN12616001713482
- Lead Sponsor
- Prof Anne Chang
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 77
Inclusion Criteria
Children with chronic cough. Chronic cough is defined as cough duration of >=4 weeks.
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
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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.[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 Measures
Name Time Method Proportion of participants with an improvement in parent-proxy chronic cough-specific quality of life (PC-QOL) scores.[Day 7 and 14.];Proportion of children with a reduction in fractional exhaled nitric oxide (FeNO).[Day 14.]