Status:
COMPLETED
Observed Outcomes Associated With Fluticasone Propionate/Salmeterol Xinafoate or Inhaled Corticosteroids in Asthma Patients
Lead Sponsor:
GlaxoSmithKline
Conditions:
Asthma
Eligibility:
All Genders
12-65 years
Brief Summary
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 c...
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
October 1 2010
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
January 1 2012
Estimated Enrollment :
7779 Patients enrolled
Trial Details
Trial ID
NCT01431924
Start Date
October 1 2010
End Date
January 1 2012
Last Update
February 25 2013
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