Nycomed announced plans for an international phase III/IV study investigating the effect of Daxas® (500μg 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).
Use of Daxas® with the individual components of fixed combination and triple therapy has already been shown to reduce exacerbations and improve lung function.(1,2) The REACT study is the first to investigate Daxas when used in patients concomitantly treated with fixed combination treatment or triple therapy.
The REACT trial is a 52-week, randomised, double-blind, multi-centre study which will recruit approximately 2,000 patients from 21 countries. The primary endpoint is the reduction of moderate or severe COPD exacerbations per patient per year. Moderate exacerbations are defined as those requiring oral or parenteral glucocorticosteroids and severe exacerbations are defined as requiring hospitalisation and/or leading to death. Other exacerbation endpoints will also be assessed, including the proportion of patients experiencing an exacerbation and time to first, second and third exacerbation. Quality of life will be measured using the COPD Assessment Test (CAT
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.