Asthma MedDRA version: 8.1 Level: LLT Classification code 10003553 Term: Asthma
Conditions
Interventions
Trade Name: Seretide
Product Name: Seretide
Pharmaceutical Form: Inhalation powder
Trade Name: Flixotide
Product Name: Flixotide
Pharmaceutical Form: Inhalation powder
Trade Name: Singulair
Product
Sponsors
University of Dundee
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: All children and adolescents (5-18 years) with asthma in Tayside (Scotland) known (a) to carry the Arg/Arg-16 genotype and (b) currently on inhaled steroids and (c) inhaled bronchodilators according to need will be telephoned or contacted through home visits to establish if they have had (a) any school absences from asthma or (b) out-of-hours visits to GP/hospital visits/admissions or NHS 24 contacts due to asthma over the previous 12 months. All patients fulfilling the above inclusion criteria will be invited to participate in the study. Are the trial subjects under 18? yes Number of subjects for this age range: F.1.2 Adults (18-64 years) no F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: The presence of serious respiratory or multi-system disease (e.g. cystic fibrosis, cancer under current treatment) will constitute exclusion criteria for the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To perform a randomised controlled trial (parallel design) of oral montelukast versus inhaled salmeterol on children on step 2 BTS with a history of school absences/hospital admissions due to asthma over the past year using asthma exacerbations over a period of 1 year as the primary outcome. All the patients will be on inhlaed steroids. ;Secondary Objective: 2. Secondary outcomes that will also be tested: (a) Oral montelukast is associated with reduced out-of hours visits/hospital visits or admissions in comparison to inhaled salmeterol over a period of 1 year (b) Oral montelukast is associated with a reduction in airway resistance in comparison to inhaled salmeterol over a period of 1 year (c) Oral montelukast is associated with reduced exhaled nitric oxide levels in comparison to inhaled salmeterol over a period of 1 year (d) Oral montelukast is associated with reduced salivary eosinophilic cationic protein levels in comparison to inhaled salmeterol over a period of 1 year (e) Oral montelukast is associated with improved asthma specific quality-of-life in comparison to inhaled salmeterol over a period of 1 year (f) Oral montelukast is associated with improved morning peak expiratory flow rate in comparison to inhaled salmeterol over a period of 1 year ;Primary end point(s): Oral montelukast is associated with reduced asthma exacerbations in comparison to inhaled salmeterol over a period of 1 year in Arg/Arg-16 asthmatic children | — |
Countries
United Kingdom
Outcome results
None listed