title: Roflumilast in Asian patients with COPD: A randomized placebo-controlled trial.
abstract: OBJECTIVE
  Roflumilast, an oral, selective phosphodiesterase 4 inhibitor, has been shown to reduce exacerbations and improve pulmonary function in patients with COPD. This study examined the efficacy, safety and tolerability of roflumilast in Asian patients with COPD.
  
  
  METHODS
  Patients with COPD were randomized 1:1 to enter a 12-week treatment period and receive either oral roflumilast, 500 µg once daily, or placebo, following a single-blind, 4-week baseline period in which all patients received placebo. The primary end point was mean change in FEV₁ from baseline to each postrandomization visit during the treatment period. Other spirometric lung function measurements were evaluated as secondary end points. COPD exacerbations were monitored. Safety was assessed from clinical laboratory tests, vital signs, physical examination (including electrocardiogram) and monitoring of adverse events (AEs).
  
  
  RESULTS
  Of 551 patients recruited, 410 were randomized and received at least one dose of study medication (roflumilast, n = 203; placebo, n = 207). Superiority of roflumilast over placebo was demonstrated by a statistically significant difference in postbronchodilator FEV₁ (79 mL, P < 0.0001). Other spirometry end points, including prebronchodilator FEV₁, pre-and postbronchodilator FEV₆, forced vital capacity and peak expiratory flow significantly favoured roflumilast over placebo. AEs were more common with roflumilast than with placebo, but were comparable with those reported in previous studies.
  
  
  CONCLUSIONS
  Roflumilast, 500 µg once daily, improves pulmonary function in Asian patients with COPD. The safety and tolerability of roflumilast in this population was similar to that in a Caucasian population.
authors.affiliation: Asan Medical Center, Seoul, South Korea.
authors.forename: Sang-Do
authors.initials: SD
authors.lastname: Lee
authors.forename: David S C
authors.initials: DS
authors.lastname: Hui
authors.forename: Aziah A
authors.initials: AA
authors.lastname: Mahayiddin
authors.forename: Camilo C
authors.initials: CC
authors.lastname: Roa
authors.forename: Kheng Hoe
authors.initials: KH
authors.lastname: Kwa
authors.forename: Udo-Michael
authors.initials: UM
authors.lastname: Goehring
authors.forename: Dirk
authors.initials: D
authors.lastname: Bredenbröker
authors.forename: Han-Pin
authors.initials: HP
authors.lastname: Kuo
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000631:Aminopyridines / Q000627:therapeutic use*; D000893:Anti-Inflammatory Agents / Q000627:therapeutic use*; D044466:Asian People; D001549:Benzamides / Q000627:therapeutic use*; D003521:Cyclopropanes / Q000627:therapeutic use; D004311:Double-Blind Method; D005260:Female; D005541:Forced Expiratory Volume / Q000187:drug effects*; D006801:Humans; D008297:Male; D008875:Middle Aged; D058988:Phosphodiesterase 4 Inhibitors / Q000627:therapeutic use*; D029424:Pulmonary Disease, Chronic Obstructive / Q000188:drug therapy* / Q000208:ethnology / Q000503:physiopathology; D011788:Quality of Life; D016896:Treatment Outcome; D014797:Vital Capacity / Q000187:drug effects*
chemical_list: D000631:Aminopyridines; D000893:Anti-Inflammatory Agents; D001549:Benzamides; D003521:Cyclopropanes; D058988:Phosphodiesterase 4 Inhibitors; C424423:Roflumilast