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

NCT01465529 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 26

Last updated 2015-01-14

No results posted yet for this study

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

Interventions

DRUG

OligoG CF-5/20

6% OligoG CF-5/20 in water

DRUG

Saline

0.9% NaCl in water

Sponsors & Collaborators

  • AlgiPharma AS

    lead INDUSTRY

Principal Investigators

  • Martin Walshaw, MD · Liverpool Heart & Chest Hospital, UK

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-05-31
Primary Completion
2013-10-31
Completion
2013-11-30

Countries

  • Ireland
  • United Kingdom

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01465529 on ClinicalTrials.gov