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
1 other identifier
interventional
94
1 country
1
Brief Summary
The Objective was to Develop a Cost-Effectiveness study that compares Ciclesonide and Beclomethasone in pediatric asthma control.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_4 asthma
Started Jul 2010
Shorter than P25 for phase_4 asthma
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2010
CompletedFirst Submitted
Initial submission to the registry
April 8, 2011
CompletedFirst Posted
Study publicly available on registry
April 12, 2011
CompletedApril 12, 2011
April 1, 2011
5 months
April 8, 2011
April 11, 2011
Conditions
Outcome Measures
Primary Outcomes (1)
Effectiveness measured as number of patients free of asthmatic crisis with each molecule during the study period
Effectiveness was assesed counting number of patients that were free of asthmatic crisis for each steroid ciclesonide and beclomethasone during 6 months of treatment
6 months
Study Arms (2)
Ciclesonide
ACTIVE COMPARATORBeclomethasone
PLACEBO COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- Patients with uncontrolled asthma diagnosis
- Patients with only one controller medication
You may not qualify if:
- Patients without lung infection
- Patients without antibiotic use
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Hospital San Rafael
Bogotá, 11001000, Colombia
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Francisco Hinestrosa, MD,MSc
Grünenthal Colombiana S.A.
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
April 8, 2011
First Posted
April 12, 2011
Study Start
July 1, 2010
Primary Completion
December 1, 2010
Study Completion
December 1, 2010
Last Updated
April 12, 2011
Record last verified: 2011-04