title: Real-life effectiveness of budesonide/formoterol therapy in asthma: A subanalysis of the SMARTASIA study.
abstract: BACKGROUND
  In the Study to Investigate Real Life Effectiveness of Symbicort Maintenance and Reliever Therapy in Asthma Patients Across Asia, the effectiveness of single-inhaler budesonide/formoterol maintenance and reliever therapy was evaluated in patients with poorly controlled asthma.
  
  
  OBJECTIVE
  To study the effects of this therapy on a Chinese patient subgroup.
  
  
  METHODS
  In this 12-week, multicenter, open-label therapeutic phase IV study, patients with partially controlled or uncontrolled asthma were switched from their usual asthma treatment to budesonide/formoterol (160/4.5 μg, one inhalation twice daily and as needed) after a 2-week run-in period. Primary and secondary objectives of the study, asthma control and quality of life were assessed by using the five-item Asthma Control Questionnaire and the Standardized Asthma Quality of Life Questionnaire. Asthma symptom scores, study medication use, asthma control and/or symptom-free days, and the number of asthma-related nighttime awakenings were also monitored.
  
  
  RESULTS
  In total, 478 Chinese patients were enrolled and 407 patients initiated treatment. The patients displayed a significant improvement in mean (standard deviation) five-item Asthma Control Questionnaire (-0.58 ± 0.86; p < 0.0001) and Standardized Asthma Quality of Life Questionnaire (0.69 ± 0.79; p < 0.0001) scores versus the run-in period. Mean (standard deviation) asthma symptom scores were significantly reduced compared with run-in (-0.30 ± 0.55 daytime, -0.31 ± 0.56 nighttime; p < 0.0001 for both), as was as-needed study medication use (-0.24 ± 1.16 daytime, -0.28 ± 0.97 nighttime; p < 0.0001 for both). Patients who received previous treatment with salmeterol/fluticasone propionate also showed improvement in asthma control.
  
  
  CONCLUSIONS
  In China, asthma control in Chinese patients whose asthma was not fully controlled with previous standard therapy improved during 12 weeks of treatment with budesonide/formoterol maintenance and reliever therapy. Quality of life was improved, and treatment was well tolerated. (Clinical Trials identifier NCT00939341).
authors.affiliation: Department of Respiratory Diseases, China-Japan Friendship Hospital, Peking University, Beijing, China.
authors.forename: Jiangtao
authors.initials: J
authors.lastname: Lin
authors.forename: Yan
authors.initials: Y
authors.lastname: Tang
authors.forename: Qingyu
authors.initials: Q
authors.lastname: Xiu
authors.forename: Jian
authors.initials: J
authors.lastname: Kang
authors.forename: Shaoxi
authors.initials: S
authors.lastname: Cai
authors.forename: Kewu
authors.initials: K
authors.lastname: Huang
authors.forename: Yohji
authors.initials: Y
authors.lastname: Itoh
authors.forename: Xia
authors.initials: X
authors.lastname: Ling
authors.forename: Nanshan
authors.initials: N
authors.lastname: Zhong
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D018927:Anti-Asthmatic Agents / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D001249:Asthma / Q000175:diagnosis / Q000188:drug therapy*; D019819:Budesonide / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D004359:Drug Therapy, Combination; D005260:Female; D000068759:Formoterol Fumarate / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D006801:Humans; D008297:Male; D008875:Middle Aged; D011788:Quality of Life; D012129:Respiratory Function Tests; D012307:Risk Factors; D016896:Treatment Outcome; D055815:Young Adult
chemical_list: D018927:Anti-Asthmatic Agents; D019819:Budesonide; D000068759:Formoterol Fumarate