A Randomised Controlled Trial of the efficacy and safety of an Inhaled Corticosteroid and Long Acting Beta Agonist as maintenance and reliever therapy versus as prescribed maintenance with salbutamol as reliever therapy in children with moderate and severe asthma.
- Conditions
- AsthmaRespiratory - Asthma
- Registration Number
- ACTRN12623001339640
- Lead Sponsor
- The University of Auckland
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot yet recruiting
- Sex
- All
- Target Recruitment
- 376
1. Aged 4 to 11 years
2. Doctor or Nurse Practitioner (NP) diagnosis of asthma (self-report by parent/participant or healthcare provider-reported)
3. Use of maintenance ICS or ICS-LABA + SABA reliever therapy in the last 6 months (i.e. GINA step 2, 3 and 4)
4. Registered with a General Practitioner (GP)
5. Willing and able to switch from current treatment regimen
1. Significant other comorbidity including, but not limited to, cystic fibrosis and bronchiectasis or arrythmia
2. Previous life-threatening asthma (ICU admission ever or intravenous (IV) treatment in last 2 years)
3. Already using ICS-LABA as a reliever
4. GINA step 5 (few children only, brittle asthma, and potentially difficult to manage in an RCT without regular face-to-face contact); use of biologics, high dose ICS-LABA, maintenance oral corticosteroids, or leukotriene receptor antagonists in the last 6 months
5. Systemic corticosteroids in last 6 weeks prior to Visit 1
6. Any known or suspected hypersensitivity (including rash, urticaria, angioedema, bronchospasm and anaphylactic reaction) to the active substances in the study (budesonide, formoterol, salbutamol)
7. Participation in another clinical trial of an investigational medicinal product in the 30 days prior to Visit 1
8. Ex-preterm infant (born <37 weeks)
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method