NCT02157922

A Phase IIb Study of OligoG in Subjects With Cystic Fibrosis

A Double-blind, Randomized, Placebo-controlled Cross Over Study of Inhaled Alginate Oligosaccharide (OligoG) Administered for 28 Days in Subjects With Cystic Fibrosis

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 65 (actual)
• Sponsor: AlgiPharma AS · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of the study is assessment of efficacy and safety of OligoG as a dry powder formulation, in adult subjects with cystic fibrosis.

Detailed description

The primary objective is to demonstrate efficacy of inhaled OligoG measured by FEV1, and supported by secondary endpoints including Mucociliary Clearance, rheology,microbiology and Quality-of-Life. The secondary objectives are 1. To demonstrate the safety and tolerability of inhaled OligoG as a dry powder for inhalation after multiple dose administration; and 2. To evaluate patient compliance with treatment. The design will be randomized, double-blind, placebo-controlled, multi-center, cross-over phase II study. Mucociliary and Cough clearance (MCC) will be an exploratory endpoint in a subset of 24 patients, and Lung Clearance Index (LCI) an exploratory endpoint in another subset of 20 or more patients.

Conditions

• Cystic Fibrosis

Interventions

Type	Name	Description
DRUG	alginate oligosaccharide	Inhalation

Timeline

• Start date: 2014-10-01
• Primary completion: 2017-01-01
• Completion: 2017-09-01
• First posted: 2014-06-06
• Last updated: 2018-04-19

Locations

18 sites across 5 countries: Denmark, Germany, Norway, Sweden, United Kingdom