Cost-effectiveness Study of Beclomethasone Versus Ciclesonide as Controller Medications in Pediatric Asthma

Phase 4

Completed

• Conditions: Asthma
• Interventions: Drug: Ciclesonide; Drug: Beclomethasone

• Registration Number: NCT01333800
• Lead Sponsor: Grünenthal Colombiana S.A.

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.

Study Timeline

• Study Start: 2010-07
• Primary Completion: 2010-12
• Study Completion: 2010-12
• Status Verified: 2011-04
• Study First Submitted: 2011-04-08
• Study First Submitted QC: 2011-04-11
• Last Update Submitted: 2011-04-11
• Study First Posted: 2011-04-12
• Last Update Posted: 2011-04-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 94

Inclusion Criteria

• Patients with uncontrolled asthma diagnosis
• Patients with only one controller medication

Exclusion Criteria

• Patients without lung infection
• Patients without antibiotic use

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Ciclesonide	Ciclesonide	-
Beclomethasone	Beclomethasone	-

Primary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Hospital San Rafael; 🇨🇴 Bogotá, Colombia