title: Patient-reported outcomes among omalizumab and salmeterol/fluticasone combination therapy patients.
abstract: BACKGROUND
  Some asthma patients remain poorly controlled despite receiving care consistent with treatment guidelines.
  
  
  OBJECTIVE
  This study compared the ability to sleep, work, and participate in leisure activities among subjects with immunoglobulin E-mediated (allergic) asthma initiating omalizumab (omalizumab start group) with subjects receiving moderate-to-high doses of salmeterol/fluticasone combination therapy, who continued on salmeterol/fluticasone combination therapy for at least a year without adding omalizumab (salmeterol/fluticasone combination continuation group).
  
  
  METHODS
  Subjects completed an Internet-based screener and, if eligible, an Internet-based questionnaire. A propensity score model was utilized in the analysis. Group differences were assessed through logistic and linear regression models. Analyses were adjusted for propensity score quintile, how subjects heard about the study, and responses to retrospective single-item questions.
  
  
  RESULTS
  The analysis population included 86 omalizumab start group subjects and 436 salmeterol/fluticasone combination continuation subjects, recruited from June to November 2006. In the adjusted analyses, the omalizumab start group was more than twice as likely to have controlled asthma as measured by the Asthma Control Test (odds ratio, 2.62; p = 0.005). The omalizumab start group had significantly fewer sleep disturbances as measured by the Jenkins Sleep Evaluation Questionnaire (least-square means difference, -1.65;p = 0.004), less activity impairment as measured by the Work Productivity Activity Impairment-Asthma Scale (least-square means difference, -13.36;p < 0.001), and less difficulty in activities as measured by the Valued Life Activities Questionnaire (least-square means difference, -0.24; p < 0.001).
  
  
  CONCLUSIONS
  Asthma subjects who started taking omalizumab reported more improvement in asthma control, fewer sleep problems, less activity impairment, and less difficulty with activities than a similar cohort of subjects who continued taking salmeterol/fluticasone combination therapy.
authors.affiliation: ICON Clinical Research, San Francisco, CA 94105, USA. dave.miller@iconplc.com
authors.forename: Dave P
authors.initials: DP
authors.lastname: Miller
authors.forename: Gladys
authors.initials: G
authors.lastname: Tom
authors.forename: Lawrence
authors.initials: L
authors.lastname: Rasouliyan
authors.forename: Bradley
authors.initials: B
authors.lastname: Chipps
mesh_terms: D000203:Activities of Daily Living; D000328:Adult; D000420:Albuterol / Q000031:analogs & derivatives* / Q000627:therapeutic use; D000730:Androstadienes / Q000627:therapeutic use*; D018927:Anti-Asthmatic Agents / Q000627:therapeutic use; D000888:Antibodies, Anti-Idiotypic; D000911:Antibodies, Monoclonal / Q000627:therapeutic use*; D061067:Antibodies, Monoclonal, Humanized; D001249:Asthma / Q000150:complications / Q000188:drug therapy*; D004338:Drug Combinations; D004526:Efficiency; D005260:Female; D000068297:Fluticasone-Salmeterol Drug Combination; D006801:Humans; D020407:Internet; D007899:Leisure Activities; D008297:Male; D008875:Middle Aged; D000069444:Omalizumab; D017060:Patient Satisfaction; D012893:Sleep Wake Disorders / Q000209:etiology; D011795:Surveys and Questionnaires; D016896:Treatment Outcome
chemical_list: D000730:Androstadienes; D018927:Anti-Asthmatic Agents; D000888:Antibodies, Anti-Idiotypic; D000911:Antibodies, Monoclonal; D061067:Antibodies, Monoclonal, Humanized; D004338:Drug Combinations; D000068297:Fluticasone-Salmeterol Drug Combination; D000069444:Omalizumab; D000420:Albuterol