Asthma (paediatric population) Respiratory Asthma
Conditions
Interventions
1. Inhaled fluticasone propionate 100 µg twice daily plus placebo tablet once daily
2. Inhaled fluticasone propionate 100 µg and salmeterol 50 µg twice daily (combination inhaler) p
Sponsors
University Hospital of North Staffordshire NHS Trust (UK)
Keele University (UK)
University Hospital of North Staffordshire NHS Trust
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria
Exclusion criteria: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 1. Quality of Life measured by the Juniper QoL questionnaire, collected at baseline, randomisation, then +8 weeks, +24 weeks, +36 weeks and +48 weeks 2. Time from randomisation to first exacerbation requiring treatment with a short course of oral corticosteroids, collected at baseline, randomisation, then +8 weeks, +24 weeks, +36 weeks and +48 weeks 3. School attendance, collected at baseline, randomisation, then +8 weeks, +24 weeks, +36 weeks and +48 weeks 4. Hospital admissions, collected at baseline, randomisation, then +8 weeks, +24 weeks, +36 weeks and +48 weeks 5. Amount of rescue beta-2 agonist therapy prescribed, collected at baseline, randomisation, then +8 weeks, +24 weeks, +36 weeks and +48 weeks 6. Time from randomisation to treatment withdrawal (due to lack of efficacy or side effects), collected at baseline, randomisation, then +8 weeks, +24 weeks, +36 weeks and +48 weeks 7. Lung function (as assessed by spirometry), conducted at baseline/randomisation (T0) and randomisation + 48 weeks (T48) | — |
Countries
United Kingdom
Outcome results
None listed