Last updated: 11/07/2018 04:54:11
Outcomes in patients taking fluticasone propionate/salmeterol combination or other inhaled corticosteroids
Clinicaltrials.gov ID
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Finalized
Finalized
Trial overview
Official title: Comparison of Healthcare Utilization and Costs in Patients with Asthma who Fluticasone/Salmeterol Inhalation Powder versus other Inhaled Corticosteroid(s) in Typical Clinical Practice Using Health Insurance Claims Data.
Trial description: The objective of this study is to compare healthcare utilization and costs in asthma patients who receive fluticasone propionate/salmeterol combination 100mcg/50mcg (“FSC 100/50”) or inhaled corticosteriods in typical clinical practice using a retrospective observational cohort study design of large managed care database.
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:
To assess the difference in asthma related exacerbations
Timeframe: 90 days post index
Secondary outcomes:
Not applicable
Interventions:
Drug: Fluticasone propionate/salmeterol combination
Drug: Inhaled corticosteroids
Enrollment:
5180
Observational study model:
Cohort
Primary completion date:
Not applicable
Time perspective:
Retrospective
Clinical publications:
Hagiwara M, Delea T, Stanford RS.Risk of asthma exacerbation, asthma-related healthcare utilization and costs, and adherence to controller therapy in patients with asthma receiving fluticasone propionate/salmeterol inhalation powder 100mcg/50mcg vs. mometasone furoate inhalation powder.J Asthma.2013;50(3):287-295
Medical condition
Asthma
Product
fluticasone propionate, fluticasone propionate/salmeterol, salmeterol
Collaborators
Not applicable
Study date(s)
June 2009 to December 2010
Type
Observational
Phase
Not applicable
Participation criteria
Sex
Female & Male
Age
12 - 65 years
Accepts healthy volunteers
No
- Subjects with asthma as determined by ICD-9 codes and asthma drug use
- at least 12 years of age
- Subjects with COPD or treatment for COPD
Inclusion and exclusion criteria
Inclusion criteria:
- Subjects with asthma as determined by ICD-9 codes and asthma drug use
- at least 12 years of age
- treated with inhaled corticosteroids
Exclusion criteria:
- Subjects with COPD or treatment for COPD
Trial location(s)
No location data available.
Study documents
Clinical study report
Available language(s): English
Scientific result summary
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Refer to study documents
Recruitment status
Finalized
Actual primary completion date
Not applicable
Actual study completion date
2010-15-12
Plain language summaries
Not applicable. GSK’s transparency policy provides for Plain Language Summaries for Interventional studies.
Additional information about the trial
Not applicable
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