Outcomes for Medicare Asthma Patients Taking Fluticasone Propionate/Salmeterol Xinafoate Combination Versus Inhaled Corticosteroids or Other Combination Therapy
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|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|
|Primary Completion Date :||April 2010|
|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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01347060
|Study Director:||GSK Clinical Trials||GlaxoSmithKline|