Advertise With UsAdvertise on our extensive network of industry websites and newsletters.
Get the PBR newsletterSign up to our free email to get all the latest PBR
news.Nycomed plans to begin an international Phase III/IV study investigating the effect of Daxas (500mcg tablets, once daily) versus placebo on exacerbation rates in COPD patients who are concomitantly treated with fixed combination long-acting-ß2-agonists (LABA) and inhaled corticosteroids (ICS), with or without a long-acting muscarinic antagonist (LAMA).
Subscribe to our email newsletter
Daxas (roflumilast) is an orally administered selective phosphodiesterase 4 (PDE4) enzyme inhibitor, which has been shown to inhibit COPD related inflammation with a novel mode of action.
The REACT study, a 52-week, randomised, double-blind, multi-centre study which will recruit approximately 2,000 patients from 21 countries, is the first to investigate Daxas when used in patients concomitantly treated with fixed combination treatment or triple therapy.
The trial will recruit patients with severe COPD associated with chronic bronchitis and frequent exacerbations, reflecting the licence indication for Daxas.
First patient enrolment is anticipated in second quarter 2011.