The purpose of the study is assessment of efficacy and safety of OligoG as a dry powder formulation, in adult subjects with cystic fibrosis.
Name: alginate oligosaccharideDescription: InhalationType: Drug
Alginate oligosaccharide Placebo
Description: An improvement in FEV1 during treatment with OligoG as compared to placebo is the primary endpoint of the study.Measure: FEV1 (Forced Expiratory Volume in 1 second) Time: 28 days, i.e. start and end of treatment periods
Description: Mucociliary clearance is assessed by measuring the movement of an inhaled radiotracer up the airways.Measure: Mucociliary and cough clearance Time: 28 days, i.e. start and end of treatment periods
Description: Measurement of vital signs, ECG, blood oxygen saturation and pulmonary function tests. Adverse events and concomitant medications will be recorded, and blood samples will be collected for hematology, clinical chemistry and OligoG concentration.Measure: Safety Time: Screening, day 0, 14, 28, 56, 70, 84 and follow up
There is one SNP
- Diagnosed with the G551D-mutation, and currently on concomitant treatment with Ivacaftor (Kalydeco). --- G551D ---