title: Efficacy of theophylline plus salmeterol/fluticasone propionate combination therapy in patients with asthma.
abstract: OBJECTIVE
  To compare the efficacy of theophylline plus salmeterol/fluticasone propionate combination product (SFC) with SFC plus placebo in asthmatic patients.
  
  
  METHODS
  In this randomized, stratified, parallel-group study, 325 patients were randomized to receive either 200 mg theophylline plus 50/250 μg SFC or placebo tablet plus 50/250 μg SFC twice daily for 24 weeks. Outcome variables included the level of asthma control (assessed by the Asthma Control Test) and the number of patients experiencing ≥1 exacerbations during the 24-week treatment period. Testing of lung function as well as measurement of the levels of inflammatory markers in induced sputum was performed.
  
  
  RESULTS
  There were significantly fewer patients with ≥1 asthma exacerbation in the theophylline plus SFC group (29.6%) when compared with the SFC plus placebo group (46.9%) (p = 0.004). Theophylline plus SFC improved the FEF(25-75%) value, which indicates enhanced small airway function, to a greater extent than SFC plus placebo (66.9 ± 18.8% and 57.4 ± 17.6%, respectively; p < 0.001). A significant decrease in eosinophil count and concentration of eosinophil cationic protein in induced sputum was also seen in the theophylline plus SFC group when compared with the SFC plus placebo group (4.1 ± 2.2% and 6.3 ± 2.7%, 63.6 ± 39.5 μg/L and 89.4 ± 45.6 μg/L, respectively; all p < 0.01).
  
  
  CONCLUSIONS
  The combination of theophylline plus SFC may provide greater protection against asthma exacerbations, and its administration is accompanied by significant improvements in small airway function and airway inflammation.
authors.affiliation: Department of Respiratory Medicine, Renmin Hospital of Wuhan University, 238 Jiefang Road, Wuchang District, Wuhan 430060, China. nhxiang@yahoo.cn
authors.forename: Hanxiang
authors.initials: H
authors.lastname: Nie
authors.forename: Guqin
authors.initials: G
authors.lastname: Zhang
authors.forename: Min
authors.initials: M
authors.lastname: Liu
authors.forename: Xuhong
authors.initials: X
authors.lastname: Ding
authors.forename: Yi
authors.initials: Y
authors.lastname: Huang
authors.forename: Suping
authors.initials: S
authors.lastname: Hu
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D000420:Albuterol / Q000031:analogs & derivatives* / Q000627:therapeutic use; D000730:Androstadienes / Q000627:therapeutic use*; D001249:Asthma / Q000188:drug therapy* / Q000378:metabolism / Q000503:physiopathology; D001993:Bronchodilator Agents / Q000627:therapeutic use; D002940:Circadian Rhythm / Q000502:physiology; D004338:Drug Combinations; D004359:Drug Therapy, Combination; D005260:Female; D000068297:Fluticasone-Salmeterol Drug Combination; D005938:Glucocorticoids / Q000627:therapeutic use; D006801:Humans; D018836:Inflammation Mediators / Q000378:metabolism; D008297:Male; D008875:Middle Aged; D010366:Peak Expiratory Flow Rate / Q000187:drug effects / Q000502:physiology; D015656:Respiratory Mechanics / Q000187:drug effects / Q000502:physiology; D013183:Sputum / Q000737:chemistry; D013806:Theophylline / Q000627:therapeutic use*; D016896:Treatment Outcome; D055815:Young Adult
chemical_list: D000730:Androstadienes; D001993:Bronchodilator Agents; D004338:Drug Combinations; D000068297:Fluticasone-Salmeterol Drug Combination; D005938:Glucocorticoids; D018836:Inflammation Mediators; D013806:Theophylline; D000420:Albuterol