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

Asthma Clinical Trial

Official title:

Phase 4 Cost-effectiveness Study of Beclomethasone Versus Ciclesonide as Controller Medications in Pediatric Asthma in a Hospital in Bogotá

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01333800
• Other study ID #: CO-AL-FE-001
• Status: Completed
• Phase: Phase 4
• First received: April 8, 2011
• Last updated: April 11, 2011
• Start date: July 2010
• Est. completion date: December 2010

Study information

• Verified date: April 2011
• Source: Grünenthal Colombiana S.A.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Colombia: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

The Objective was to Develop a Cost-Effectiveness study that compares Ciclesonide and Beclomethasone in pediatric asthma control.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 94
• Est. completion date: December 2010
• Est. primary completion date: December 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 6 Years to 15 Years

Eligibility

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

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Asthma

Intervention

Drug:
• Beclomethasone
200 to 400 mcg per day for 6 months
• Ciclesonide
80 to 160 mcg per day for 6 months

Locations

Country	Name	City	State
Colombia	Hospital San Rafael	Bogotá

Sponsors (1)

Lead Sponsor	Collaborator
Grünenthal Colombiana S.A.

Country where clinical trial is conducted

Colombia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Effectiveness measured as number of patients free of asthmatic crisis with each molecule during the study period	Effectiveness was assesed counting number of patients that were free of asthmatic crisis for each steroid ciclesonide and beclomethasone during 6 months of treatment	6 months	No