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

Grünenthal

Status and phase: Completed; Phase 4

Conditions: Asthma

Treatments: Drug: Beclomethasone; Drug: Ciclesonide

Study type: Interventional

Funder types: Industry

Identifiers

NCT01333800

CO-AL-FE-001

Details and patient eligibility

About

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

Full 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.

Enrollment: 94 patients

Sex: All

Ages: 6 to 15 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

• Patients without lung infection
• Patients without antibiotic use

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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94 participants in 2 patient groups, including a placebo group

Ciclesonide

Active Comparator group

Treatment:

Drug: Ciclesonide

Beclomethasone

Placebo Comparator group

Treatment:

Drug: Beclomethasone