The clinical trial has been designed in accordance with EMA guidelines. It will be a multi-center, randomized, double-blind, placebo-controlled, parallel group, dose finding study in patients with cystic fibrosis. The trial is divided into two parts, with part 1 designed to identify the best dose, while part 2 is designed to assess the efficacy, safety and tolerability of the inhaled alginate oligosaccharide OligoG compared to placebo after 26 weeks of treatment, followed by a 26 weeks open label extension. Randomised patients will receive daily administrations of OligoG or placebo, both administered in addition to standard of care for 26 weeks. All patients will be offered OligoG in an open label study extension of an additional 26 weeks. An Independent Data Monitoring Committee (IDMC) will assess the safety throughout the study, and select the optimal OligoG dose based on efficacy and safety data from an interim analysis performed after all subjects have received 26 weeks of treatment.
Additional details about this clinical trial are available at www.oligogpivotalcf and at www.clinicaltrials.gov