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A Study of OligoG in Cystic Fibrosis Subjects With Burkholderia Spp. Infection — SMR-2591  

Cystic Fibrosis Clinical Trial

Official title:
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.

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT02453789
Study type Interventional
Source AlgiPharma AS
Contact
Status Completed
Phase Phase 2
Start date February 2015
Completion date December 2017
View Details
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