mdlinx mdlinx
Latest (53) Full Text Articles (1939) Focus on Apnea Article Summary

Roflumilast in Asian patients with COPD: A randomized placebo-controlled trial
Respirology,  Clinical Article

Lee SD et al. - Roflumilast, 500 μg once daily, improves pulmonary function in Asian patients with chronic obstructive pulmonary disease (COPD). The safety and tolerability of roflumilast in this population was similar to that in a Caucasian population.

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 endpoint was mean change in FEV1 from baseline to each postrandomization visit during the treatment period.
  • Other spirometric lung function measurements were evaluated as secondary endpoints.
  • 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 endpoints, 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.

Please login or register to follow this author.
Are you sure you want to Unfollow this Author?
► Click here to access PubMed, Publisher and related articles...

Your Unread Messages in Pulmonology

See All >> Messages include industry-sponsored communications and special communications from MDLinx

Most Popular Pulmonology Articles

Last month's top read Top Articles of 2013

Indexed Journals in Pulmonology: Chest, Thorax, American Journal of Respiratory and Critical Care Medicinemore

Other Topics in Pulmonology

Register now to view all the MDLinx contents (FREE)!

  • Stay current on the latest literature, research and clinical news
  • Get special communications and offers from MDLinx and our sponsors
  • Receive invitations to paid market research
View Samples and Register

Stay current - Media Tool

Newsletter
RSS
Follow
Like

Receive the latest mecial news
updates for free via email

Sign up!

Subscribe to our free RSS feeds:

Get the latest news in your specialty automatically added to your newsreader or your personal My Yahoo!, Google, My MSN or My AOL page. Learn More

Close