A dose finding study of OligoG in patients with Cystic Fibrosis
The clinical trial 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.