NCT02453789

A Study of OligoG in Cystic Fibrosis Subjects With Burkholderia Spp. Infection

A Randomized Double-blind, Placebo-controlled Cross-over Study of Inhaled Alginate Oligosaccharide (OligoG) for 28 Days in Subjects With Cystic Fibrosis Using Aztreonam Due to Chronic Colonization With Burkholderia Spp.

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 15 (actual)
• Sponsor: AlgiPharma AS · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of the study is to assess the efficacy of Alginate oligosaccharide (OligoG) dry powder for inhalation in cystic fibrosis (CF) patients with a Burkholderia spp. infection.

Detailed description

Primary objective: To explore the efficacy of inhaled OligoG in reducing the microbial burden of Burkholderia spp. as measured in expectorated sputum samples. Secondary objectives: To explore the effect of inhaled OligoG on various efficacy variables such as lung function, Quality-of-Life, rheology and other microbiological outcome measures. To evaluate the safety, tolerability and subject compliance with treatment The study will also evaluate the effect of inhaled OligoG on various efficacy variables such as lung function, Quality-of-Life, rheology and other microbiological outcome measures, and evaluate the safety and patient compliance with treatment.

Conditions

• Cystic Fibrosis
• Burkholderia Infection

Interventions

Type	Name	Description
DRUG	Alginate oligosaccharide	Inhalation of dry powder for inhalation (DPI)
DRUG	Placebo

Timeline

• Start date: 2015-02-01
• Primary completion: 2017-03-01
• Completion: 2017-12-01
• First posted: 2015-05-27
• Last updated: 2018-04-19

Locations

2 sites across 1 country: Germany