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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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17 October 2012 |
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Main ID: |
NCT01333800 |
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Date of registration:
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08/04/2011 |
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Primary sponsor: |
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Public title:
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Cost-effectiveness Study of Beclomethasone Versus Ciclesonide as Controller Medications in Pediatric Asthma
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Scientific title:
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Phase 4 Cost-effectiveness Study of Beclomethasone Versus Ciclesonide as Controller Medications in Pediatric Asthma in a Hospital in Bogotá |
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Date of first enrolment:
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July 2010 |
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Target sample size:
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94 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT01333800 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment
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Countries of recruitment
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Colombia
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Contacts
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Name:
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Francisco Hinestrosa, MD,MSc |
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Address:
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Telephone:
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Email:
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Affiliation:
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Grünenthal Colombiana S.A. |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Patients with uncontrolled asthma diagnosis
- Patients with only one controller medication
Exclusion Criteria:
- Patients without lung infection
- Patients without antibiotic use
Age minimum:
6 Years
Age maximum:
15 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Asthma
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Intervention(s)
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Drug: Beclomethasone
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Drug: Ciclesonide
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Primary Outcome(s)
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Effectiveness measured as number of patients free of asthmatic crisis with each molecule during the study period
[Time Frame: 6 months]
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Secondary ID(s)
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CO-AL-FE-001
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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