Last updated: 11/07/2018 04:54:23
Outcomes for Medicare asthma patients taking fluticasone propionate/salmeterol xinafoate combination versus Inhaled Corticosteroids or other combination therapy
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Finalized
Finalized
Trial overview
Official title: Outcomes for Medicare asthma patients taking fluticasone propionate/salmeterol xinafoate combination versus Inhaled Corticosteroids or other combination therapy
Trial description: The objective of this study is to compare healthcare utilization and costs in Medicare-eligible asthma patients (aged >65) who receive fluticasone propionate/salmeterol xinafoate combination or inhaled corticosteroids in a typical clinical practice using a retrospective observational cohort study design of large managed care database. Outcomes on interest include asthma related severe exacerbations defined as asthma related emergency department visits, hospitalizations or combined emergency department/hospitalization. Other outcomes of interest include use of albuterol, oral corticosteroids and overall asthma related costs. Outcomes of interest will be compared between the two treatment cohorts (fluticasone propionate/salmeterol xinafoate combination or inhaled corticosteroids). Dichotomous outcomes (emergency visits, hospitalizations etc) will be compared using Cox regression hazards analysis assessing time to first event for each asthma related endpoint adjusting for differences in baseline demographics such as age, gender, previous asthma medication use, co morbidities, costs, and plan demographics. Total asthma related costs will also be compared using generalized linear models adjusting for baseline differences.
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:
Mean number of post-index asthma-related events measured using medical and pharmacy claims
Timeframe: Up to 7 years from July 1, 2001 to June 30, 2008
Secondary outcomes:
Mean asthma-related costs in the post-index period
Timeframe: Up to 7 years from July 1, 2001 to June 30, 2008
Mean number of albuterol (short-acting β-Agonists) canisters dispensed per pharmacy claim per participant
Timeframe: Up to 7 years from July 1, 2001 to June 30, 2008
Interventions:
Drug: fluticasone propionate/salmeterol xinafoate combination
Drug: inhaled corticosteroids
Enrollment:
17448
Observational study model:
Cohort
Primary completion date:
2010-01-04
Time perspective:
Retrospective
Clinical publications:
Stanford RH, Blanchette CM, Roberts MH, Petersen H, Fuhlbrigge AL.Effect of combination fluticasone propionate and salmeterol or inhaled corticosteroids on asthma-related outcomes in a Medicare eligible population.Am J Geriatr Pharmacother.2012;6(10):343-351
Medical condition
Asthma
Product
fluticasone propionate, fluticasone propionate/salmeterol, salmeterol
Collaborators
Not applicable
Study date(s)
July 2009 to April 2010
Type
Observational
Phase
Not applicable
Participation criteria
Sex
Female & Male
Age
65+ years
Accepts healthy volunteers
No
- Subjects with asthma as determined by ICD-9 codes and asthma drug use
- at least 65 years of age
- a diagnosis of chronic obstructive pulmonary disease or
- a prescription for a chronic obstructive pulmonary disease treatment
Inclusion and exclusion criteria
Inclusion criteria:
- Subjects with asthma as determined by ICD-9 codes and asthma drug use
- at least 65 years of age
- prescription for an inhaled corticosteroid
Exclusion criteria:
- a diagnosis of chronic obstructive pulmonary disease or
- a prescription for a chronic obstructive pulmonary disease treatment
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
2010-01-04
Actual study completion date
2010-01-04
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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