Randomised placebo controlled trial of inhaled corticosteroids for treatment of acute and chronic cough in children.
Phase 4
- Conditions
- Acute and chronic cough in children.Respiratory - Other respiratory disorders / diseases
- Registration Number
- ACTRN12611000589987
- Lead Sponsor
- Prof Anne Chang
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot yet recruiting
- Sex
- All
- Target Recruitment
- 161
Inclusion Criteria
Children with acute or chronic cough.
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
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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.[Cough verbal category descriptive score to be scored daily for 28 days. Endpoint of study medication is day 14.]
- Secondary Outcome Measures
Name Time Method Presence of viral infection detected from nasal swab.[Nasal swab to be collected at baseline, day 7, day 14 and day 28.];Difference in Cough Quality of Life scores.[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.]