Outcomes for Medicare Asthma Patients Taking Fluticasone Propionate/Salmeterol Xinafoate Combination Versus Inhaled Corticosteroids or Other Combination Therapy
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|ClinicalTrials.gov Identifier: NCT01347060|
Recruitment Status : Completed
First Posted : May 4, 2011
Results First Posted : June 1, 2011
Last Update Posted : May 25, 2017
|Condition or disease||Intervention/treatment|
|Asthma||Drug: fluticasone propionate/salmeterol xinafoate combination Drug: inhaled corticosteroids|
|Study Type :||Observational|
|Actual Enrollment :||17448 participants|
|Official Title:||Outcomes for Medicare Asthma Patients Taking Fluticasone Propionate/Salmeterol Xinafoate Combination Versus Inhaled Corticosteroids or Other Combination Therapy|
|Study Start Date :||July 2009|
|Actual Primary Completion Date :||April 2010|
|Actual Study Completion Date :||April 2010|
Medicare-eligible subjects with asthma
Asthma subjects at least 65 years of age enrolled in a large Medicare managed care health plan.
Drug: fluticasone propionate/salmeterol xinafoate combination
Fluticasone propionate/salmeterol xinafoate combination for asthma, all doses (100mcg/50mcg, 250 mcg/50mcg and 500 mcg/50mcg)
Other Name: Advair (TM)Drug: inhaled corticosteroids
Inhaled corticosteroids: beclomethasone dipropionte, mometasone, fluticasone propionate, budesonide, and flunisolide
- Mean Number of Post-index Asthma-related Events Measured Using Medical and Pharmacy Claims [ Time Frame: Up to 7 years from July 1, 2001 to June 30, 2008 ]Asthma-related events were defined as events with any primary ICD-9 code of 493.xx for hospitalizations, emergency department visits, and combined hospitalization/emergency department visits. The post-index period is defined as 3-12 months after either the first administration of fluticasone propionate and salmetrol or inhaled corticosteroids. Medical and pharmacy claims are recorded healthcare encounters in a large managed care administrative insurance database.
- Mean Asthma-related Costs in the Post-index Period [ Time Frame: Up to 7 years from July 1, 2001 to June 30, 2008 ]Asthma-related costs were calculated as pharmacy costs, medical costs, and total asthma (pharmacy plus medical) costs. Medical costs were made up of asthma-related visits, hospitalizations, emergency department visits, and medical office visits. Pharmacy costs were comprised of all asthma-related medications used during the follow-up period. Medical services were identified by place of service and PharMetrics-specific confinement codes. Prescriptions were counted by 30-day fills, with fills less than 30 days rounded up to indicate one fill.
- Mean Number of Albuterol (Short-acting β-Agonists) Canisters Dispensed Per Pharmacy Claim Per Participant [ Time Frame: Up to 7 years from July 1, 2001 to June 30, 2008 ]The number of albuterol canisters dispensed was used as a surrogate marker of asthma symptoms.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01347060
|Study Director:||GSK Clinical Trials||GlaxoSmithKline|