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

This study has been completed.
Sponsor:
Information provided by:
Grünenthal Colombiana S.A.
ClinicalTrials.gov Identifier:
NCT01333800
First received: April 8, 2011
Last updated: April 11, 2011
Last verified: April 2011
History of Changes

April 8, 2011
April 11, 2011
July 2010
December 2010   (final data collection date for primary outcome measure)
Effectiveness measured as number of patients free of asthmatic crisis with each molecule during the study period [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Effectiveness was assesed counting number of patients that were free of asthmatic crisis for each steroid ciclesonide and beclomethasone during 6 months of treatment
Same as current
Complete list of historical versions of study NCT01333800 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
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Cost-effectiveness Study of Beclomethasone Versus Ciclesonide as Controller Medications in Pediatric Asthma
Phase 4 Cost-effectiveness Study of Beclomethasone Versus Ciclesonide as Controller Medications in Pediatric Asthma in a Hospital in Bogotá

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

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.
Interventional
Phase 4
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment
Asthma
  • Drug: Beclomethasone
    200 to 400 mcg per day for 6 months
  • Drug: Ciclesonide
    80 to 160 mcg per day for 6 months
  • Active Comparator: Ciclesonide
    Intervention: Drug: Ciclesonide
  • Placebo Comparator: Beclomethasone
    Intervention: Drug: Beclomethasone
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
94
December 2010
December 2010   (final data collection date for primary outcome measure)

Inclusion Criteria:

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

Exclusion Criteria:

  • Patients without lung infection
  • Patients without antibiotic use
Both
6 Years to 15 Years
No
Contact information is only displayed when the study is recruiting subjects
Colombia
 
NCT01333800
CO-AL-FE-001
Yes
Francisco Hinestrosa, Grünenthal Colombiana S.A.
Grünenthal Colombiana S.A.
Not Provided
Principal Investigator: Francisco Hinestrosa, MD,MSc Grünenthal Colombiana S.A.
Grünenthal Colombiana S.A.
April 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP