Asthma
Conditions
Brief summary
The Objective was to Develop a Cost-Effectiveness study that compares Ciclesonide and Beclomethasone in pediatric asthma control.
Detailed description
Cost-effectiveness study, of cohorts, observational, analytic, prospective, from health institution perspective. Based on published data related to percentage of patients free of crisis for both molecules, it was estimated that the sample size to detect significant differences between the two alternatives was 20 patients per alternative. Medical records of 94 patients with diagnosis of uncontrolled asthma were included, aged between 6 and 15 years, 47 received Beclomethasone randomly, and 47 received Ciclesonide randomly, treatment physician was blind related to this assignation, both cohorts were followed for 6 months, and primary effectiveness variable was defined as number of patients free of crisis with each alternative. Cost generating variables were defined as medication use, and hospital stay. Decision analysis was based on a decision tree.
Interventions
DRUGBeclomethasone
200 to 400 mcg per day for 6 months
DRUGCiclesonide
80 to 160 mcg per day for 6 months
Sponsors
Grünenthal Colombiana S.A.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
6 Years to 15 Years
Healthy volunteers
No
Inclusion criteria
* Patients with uncontrolled asthma diagnosis * Patients with only one controller medication
Exclusion criteria
* Patients without lung infection * Patients without antibiotic use
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Effectiveness measured as number of patients free of asthmatic crisis with each molecule during the study period | 6 months | Effectiveness was assesed counting number of patients that were free of asthmatic crisis for each steroid ciclesonide and beclomethasone during 6 months of treatment |
Countries
Colombia
Outcome results
None listed