Last updated: 11/07/2018 07:00:45
Observed outcomes associated with fluticasone propionate/salmeterol xinafoate or inhaled corticosteroids in asthma patients
Clinicaltrials.gov ID
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Finalized
Finalized
Trial overview
Official title: Observed outcomes associated with fluticasone propionate/salmeterol xinafoate or inhaled corticosteroids in asthma patients
Trial description: This is an observational retrospective analysis of linked pharmacy and medical claims data from IMS Health/Pharmetrics database. which is a comprehensive, de-identified United States (US) healthcare claims database that is representative of the non-elderly, insurance-carrying population, The total population is 35.4 million. The average length of follow-up is 2.7 years mean (2.2 years median). Subjects will be identified in the database that have at least one ICD-9 diagnostic code (493.xx) for asthma and at least 1 asthma treatment within a 12-month period prior to the index use of fluticsasone propionate/salmeterol xinafoate or inhaled corticosteroids. Subjects will be followed in the database until they have the event of interest (asthma-related emergency department visit, hospitalization, or oral corticosteroid use or combination of asthma-related emergency department/hospitalization or asthma-related emergency department/hospitalization/oral corticosteroids) or until they are lost to follow up whichever comes first. Subjects can be censored if they leave the database, have the event of interest, or are dispensed another asthma controller other than the medication of interest. All outcomes will be assessed in the follow-up period. Time-dependent statistical models adjusting for differences in baseline (pre-index) asthma and patient demographics will be used to compare asthma events.
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:
Asthma-related exacerbations
Timeframe: Outcomes period is at least 90 days during 5-year study period
Secondary outcomes:
Not applicable
Interventions:
Drug: Higher-dose inhaled corticosteroids
Drug: Low-dose fixed dose fluticasone propionate/salmeterol xinafoate combination
Enrollment:
7779
Observational study model:
Cohort
Primary completion date:
Not applicable
Time perspective:
Retrospective
Clinical publications:
Hagiwara M, Delea TE, Stanford RH.Healthcare utilization and costs with fluticasone propionate and fluticasone propionate/salmeterol in asthma patients at risk for exacerbations. Allergy Asthma Proc.2014;35(1):54-62
Medical condition
Asthma
Product
fluticasone propionate, fluticasone propionate/salmeterol, salmeterol
Collaborators
Not applicable
Study date(s)
October 2010 to January 2012
Type
Observational
Phase
Not applicable
Participation criteria
Sex
Female & Male
Age
12 - 65 years
Accepts healthy volunteers
No
- One or more medical claims with a diagnosis (primary or secondary) of asthma (ICD-9-CM 493.XX) during study period;
- One or more outpatient pharmacy claims during the study for one or more of the following “study medications”:
- Patients with more than one of the study medications during the 3-month period beginning with the index date;
- One or more prescriptions within three months of index date (pre or post) for an ICS or LABA other than the study medications
Inclusion and exclusion criteria
Inclusion criteria:
- One or more medical claims with a diagnosis (primary or secondary) of asthma (ICD-9-CM 493.XX) during study period;
- One or more outpatient pharmacy claims during the study for one or more of the following “study medications”:
- Fluticasone propionate/salmeterol xinafoate 250 mcg/50 mcg or 100mcg/50mcg combinations
- Fluticasone propionate 110 mcg or 220 mcg
- One or more asthma exacerbations (asthma-related hospitalization or emergency department visit, oral corticosteriod prescription drug claim, or a combination of any of the above events) during the 12 months prior to the index date (“pre-index period”) or
- Five or more prescriptions for a short-acting beta agonist during the pre-index period.
Exclusion criteria:
- Patients with more than one of the study medications during the 3-month period beginning with the index date;
- One or more prescriptions within three months of index date (pre or post) for an ICS or LABA other than the study medications
- One or more prescriptions within three months of post index date for:
- Any asthma maintenance medication
- Any medical claims during study period with a diagnosis of: Chronic obstructive pulmonary disease (COPD) (ICD-9-CM 491, 492, or 496); or Respiratory tract cancer (ICD-9-CM 160-164, or 231)
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
2012-03-01
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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