Cost-effectiveness Study of Beclomethasone Versus Ciclesonide as Controller Medications in Pediatric Asthma
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Purpose
The Objective was to Develop a Cost-Effectiveness study that compares Ciclesonide and Beclomethasone in pediatric asthma control.
| Condition | Intervention | Phase |
|---|---|---|
|
Asthma |
Drug: Beclomethasone Drug: Ciclesonide |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | Phase 4 Cost-effectiveness Study of Beclomethasone Versus Ciclesonide as Controller Medications in Pediatric Asthma in a Hospital in Bogotá |
- Effectiveness measured as number of patients free of asthmatic crisis with each molecule during the study period [ Time Frame: 6 months ] [ Designated as safety issue: No ]Effectiveness was assesed counting number of patients that were free of asthmatic crisis for each steroid ciclesonide and beclomethasone during 6 months of treatment
| Enrollment: | 94 |
| Study Start Date: | July 2010 |
| Study Completion Date: | December 2010 |
| Primary Completion Date: | December 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Active Comparator: Ciclesonide |
Drug: Ciclesonide
80 to 160 mcg per day for 6 months
|
| Placebo Comparator: Beclomethasone |
Drug: Beclomethasone
200 to 400 mcg per day for 6 months
|
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.
Eligibility| Ages Eligible for Study: | 6 Years to 15 Years |
| Genders Eligible for Study: | Both |
| Accepts 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
Contacts and Locations More Information
No publications provided
| Responsible Party: | Francisco Hinestrosa, Grünenthal Colombiana S.A. |
| ClinicalTrials.gov Identifier: | NCT01333800 History of Changes |
| Other Study ID Numbers: | CO-AL-FE-001 |
| Study First Received: | April 8, 2011 |
| Last Updated: | April 11, 2011 |
| Health Authority: | Colombia: Institutional Review Board |
Additional relevant MeSH terms:
|
Asthma Bronchial Diseases Respiratory Tract Diseases Lung Diseases, Obstructive Lung Diseases Respiratory Hypersensitivity Hypersensitivity, Immediate Hypersensitivity Immune System Diseases Beclomethasone Ciclesonide |
Anti-Inflammatory Agents Therapeutic Uses Pharmacologic Actions Glucocorticoids Hormones Hormones, Hormone Substitutes, and Hormone Antagonists Physiological Effects of Drugs Anti-Asthmatic Agents Respiratory System Agents Anti-Allergic Agents |
ClinicalTrials.gov processed this record on May 22, 2013