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

Study Status: Active, not recruiting
Recruit Status: Active, not recruiting
Study Type: Interventional

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 Wit

Brief 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 Summary:

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.

Sponsor: AlgiPharma AS

Current Primary Outcome: Changes in Burkholderia spp. density in expectorated sputum and/or induced sputum. [ Time Frame: 28 days, i.e. at start and end of treatment ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

• Clinical safety as measured by vital signs [ Time Frame: Time Frame: Screening, day 0, 14, 28, 56, 70, 84 and follow up at day 112 ]
  Measurement of vital signs
• Clinical safety as measured by ECG [ Time Frame: Time Frame: Screening, day 0, 14, 28, 56, 70, 84 and follow upat day 112 ]
  Measurement of ECG
• Clinical safety as measured by blood oxygen saturation [ Time Frame: Time Frame: Screening, day 0, 14, 28, 56, 70, 84 and follow upat day 112 ]
  Measurement of blood oxygen saturation
• Clinical safety as measured by FEV1 (Forced Expiratory Volume in 1 second) [ Time Frame: Time Frame: Screening, day 0, 14, 28, 56, 70, 84 and follow up at day 112 ]
  Measurement of pulmonary function tests

Original Secondary Outcome: Same as current

Information By: AlgiPharma AS

Dates:
Date Received: May 14, 2015
Date Started: February 2015
Date Completion: May 2017
Last Updated: January 26, 2017
Last Verified: August 2016