USHO-11-3281: Predictors of stepping down asthma therapy: observational study and Fluticasone propionate-Salmeterol Combination Therapy outcomes study

Trial description: In patients with asthma taking fluticasone propionate-salmeterol combination (FSC) to treat their symptoms, prescribers may choose to ‘step-down’ those who have demonstrated controlled asthma. This step-down may be defined as switching from a higher dose of FSC to a lower dose of FSC or eliminating the salmeterol component by stepping down from FSC therapy to only inhaled corticosteroid (ICS) therapy. Although step-down is common in clinical practice, it is not well known as to which patients are more likely to have their FSC dose reduced or the salmeterol eliminated. Payers have expressed a preference to have all FSC patients step-down to ICS. Additional evidence on drug and medical use patterns in patients who ultimately step-down could be beneficial in educating payers that the three groups (i.e. FSC dose reduction, ICS step down, and those who do not step down) are different from each other.The objectives of this study are 1) To identify patient characteristics associated with step-down in patients diagnosed with asthma and taking FSC to treat their asthma symptoms 2) To identify patient characteristics associated with a type of step-down (FSC dose reduction vs step-down to ICS).Three hypotheses will be tested. Null Hypothesis 1 assumes there is no difference in demographic and asthma-related characteristics between patients who had dose reduction step-down and those who do not step-down. Null hypothesis 2 assumes ther is no difference in demographic and asthma-related characteristics between patients who had an ICS only step-down and those who do not step-down. Null Hypothesis3 assumes there is no difference in demographic and asthma-related characteristics between patients who had dose reduction step-down and those who had an ICS only step-down.The study will use the MarketScan Commercial Claims and Encounters Database. The Commercial database contains integrated medical and pharmacy claims data that is sourced directly from health plans and employers, representing over 35 million commercial lives annually. The database include detailed cost, use, and outcomes data for healthcare services performed in inpatient and outpatient settings, prescription drug claims, as well as information on patient enrollment. MarketScan data is a nationally representative database of patients enrolled with private commercial plans. These data contains all the patients’ information (demographic, treatment, utilization and costs) we plan to assess and is similar to data accessible to payers. The MarketScan data are HIPAA compliant thus all patients have been anonymized. GSK will provide the data for this study; data from January 1, 2006 through December 31, 2010 will be used.The study is a retrospective, observational cohort study