A Randomised Controlled Trial of the efficacy and safety of an Inhaled Corticosteroid and Long Acting Beta Agonist reliever therapy regimen in preschool children with mild asthma/recurrent wheeze.
- Conditions
- Asthma.Respiratory - Asthma
- Registration Number
- ACTRN12623000670673
- Lead Sponsor
- The University of Auckland
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 280
1. Aged 24 to 59 months; AND
2. >=3 wheezing episodes in the last 12 months (at least one doctor or nurse prescriber diagnosed); AND
3. Prescription of SABA in the last 12 months.
1. Previous life-threatening asthma/wheeze (intensive care unit admission or intravenous treatment); OR
2. Self-reported use of more than six SABA MDIs in the last 12 months (i.e. poorly controlled); OR
3. Use of asthma medications other than SABA or ICSs (LABA, leukotriene receptor antagonist, theophylline, anticholinergic agent or cromone) in last 3 months; OR
4. Significant other comorbidity including, but not limited to, cystic fibrosis and bronchiectasis or arrhythmia; OR
5. Unable or unwilling to switch from current treatment regimen; OR
6. Ex-preterm infant (born <37 weeks' gestation); OR
7. Children living outside urban areas (i.e. significant distance from ambulance or hospital).
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method