NCT01465529

A Cross-over Study of OligoG in Subjects With Cystic Fibrosis. Fibrosis

A Double-blind, Randomized, Placebo-controlled, Cross-over Study to Evaluate the Safety, Tolerability and Preliminary Efficacy of Alginate Oligosaccharide (OligoG) Administered for 28 Days in Subjects With Cystic Fibrosis Chronically Colonised With Pseudomonas Aeruginosa

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 26 (actual)
• Sponsor: AlgiPharma AS · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to determine the safety and local tolerability of multiple dose administration of inhaled OligoG in CF subjects. Particular emphasis will be put on local, clinical tolerance, pulmonary function and pulmonary adverse events. The secondary purpose is to monitor the effect of multiple dose administration of inhaled OligoG on various efficacy variables, such as mucolytic activity, lung function, respiratory symptoms, Quality-of-Life and microbiological outcome measures.

Conditions

• Cystic Fibrosis

Interventions

Type	Name	Description
DRUG	OligoG CF-5/20	6% OligoG CF-5/20 in water
DRUG	Saline	0.9% NaCl in water

Timeline

• Start date: 2011-05-01
• Primary completion: 2013-10-01
• Completion: 2013-11-01
• First posted: 2011-11-04
• Last updated: 2015-01-14

Locations

3 sites across 2 countries: Ireland, United Kingdom