Management of asthma in school-age children on therapy
- Conditions
- Asthma (paediatric population)RespiratoryAsthma
- Registration Number
- ISRCTN03556343
- Lead Sponsor
- niversity Hospital of North Staffordshire NHS Trust (UK)
- Brief Summary
2013 results in: http://www.ncbi.nlm.nih.gov/pubmed/23380178
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 900
1. Children with physician diagnosed asthma aged 6 years - 14 years 11 months
2. Those requiring frequent short-acting beta-2 agonist relief therapy greater than or equal to 7 puffs per week
3. Those with symptoms of asthma (i.e. wheeze, shortness of breath but not cough) resulting in:
3.1. Difficulty sleeping in the last week because of asthma symptoms and/or
3.2. Asthma has interfered with usual activities in the last week and/or
3.3. Those who have had exacerbations, defined as a short course of oral corticosteroids, an unscheduled General Practitioner (GP) or Accident and Emergency (A&E) Department visit or a hospital admission within the previous 6 months
4. Fully informed consent written (proxy) consent and assent, where appropriate
1. Children receiving long acting beta-2-agonists, leukotriene receptor antagonists, regular theophylline therapy or high dose ICS
2. Children with other respiratory diseases, cystic fibrosis, cardiac disease or immunological disorders
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The main research objective is to determine, in 6 - 14 year old children with asthma, uncontrolled on low-dose ICS, whether their control can be improved by adding in a long-acting beta-2 agonist (salmeterol) or a leukotriene receptor antagonist (montelukast) as measured by a reduced number of exacerbations requiring treatment with oral corticosteroids over the 48 week study period.
- Secondary Outcome Measures
Name Time Method