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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01333800
First Posted: April 12, 2011
Last Update Posted: April 12, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Grünenthal Colombiana S.A.
  Purpose
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.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   6 Years to 15 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01333800


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

Responsible Party: Francisco Hinestrosa, Grünenthal Colombiana S.A.
ClinicalTrials.gov Identifier: NCT01333800     History of Changes
Other Study ID Numbers: CO-AL-FE-001
First Submitted: April 8, 2011
First Posted: April 12, 2011
Last Update Posted: April 12, 2011
Last Verified: April 2011

Additional relevant MeSH terms:
Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Beclomethasone
Ciclesonide
Anti-Inflammatory Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Anti-Allergic Agents