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

This study has been completed.
Information provided by:
Grünenthal Colombiana S.A. Identifier:
First received: April 8, 2011
Last updated: April 11, 2011
Last verified: April 2011
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 (Participant, 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

Resource links provided by NLM:

Further study details as provided by Grünenthal Colombiana S.A.:

Primary Outcome Measures:
  • Effectiveness measured as number of patients free of asthmatic crisis with each molecule during the study period [ Time Frame: 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

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.

Ages Eligible for Study:   6 Years to 15 Years   (Child)
Sexes Eligible for Study:   All
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
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Please refer to this study by its identifier: NCT01333800

Hospital San Rafael
Bogotá, Colombia, 11001000
Sponsors and Collaborators
Grünenthal Colombiana S.A.
Principal Investigator: Francisco Hinestrosa, MD,MSc Grünenthal Colombiana S.A.
  More Information

Responsible Party: Francisco Hinestrosa, Grünenthal Colombiana S.A. Identifier: NCT01333800     History of Changes
Other Study ID Numbers: CO-AL-FE-001
Study First Received: April 8, 2011
Last Updated: April 11, 2011

Additional relevant MeSH terms:
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Immune System Diseases
Anti-Inflammatory Agents
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Anti-Allergic Agents processed this record on September 19, 2017