The trial is a 24-week, double-blind, placebo-controlled, randomized study comparing 60mg of denufosol inhaled three times daily to placebo in approximately 350 cystic fibrosis (CF) patients with FEV1 (Forced Expiratory Volume in one second) greater than or equal to 75% of predicted normal.
The trial’s primary efficacy endpoint is change from baseline in FEV1 (liters) at the 24-week timepoint. Secondary endpoints include other lung function parameters, pulmonary exacerbations, requirements for concomitant CF medications and quality of life. TIGER-2 is beginning with enrollment in US and Canadian sites, to be followed by enrollment in international sites later as the trial proceeds. Patients aged five years and older are eligible for enrollment. The use of standard CF maintenance therapies is permitted during the trial.