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

NCT ID: NCT01333800

Last Updated: 2011-04-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 94 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-07-31
• Study Completion Date: 2010-12-31

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.

Conditions

Asthma

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Ciclesonide

Group Type: ACTIVE_COMPARATOR

Ciclesonide

Intervention Type: DRUG

80 to 160 mcg per day for 6 months

Beclomethasone

Group Type: PLACEBO_COMPARATOR

Beclomethasone

Intervention Type: DRUG

200 to 400 mcg per day for 6 months

Interventions

Beclomethasone

200 to 400 mcg per day for 6 months

Intervention Type: DRUG

Ciclesonide

80 to 160 mcg per day for 6 months

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

• Patients without lung infection
• Patients without antibiotic use

• Minimum Eligible Age: 6 Years
• Maximum Eligible Age: 15 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Grünenthal Colombiana S.A.

INDUSTRY

Sponsor Role: lead

Responsible Party

Grünenthal Colombiana S.A.

Principal Investigators

Francisco Hinestrosa, MD,MSc

Role: PRINCIPAL_INVESTIGATOR

Grünenthal Colombiana S.A.

Locations

Hospital San Rafael

Bogotá, , Colombia

Countries

Colombia

Other Identifiers

CO-AL-FE-001

Identifier Type: -

Identifier Source: org_study_id