drugset / Trial / NCT01465529

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

NCT01465529 ↗

Phase 1/2 Completed 26 enrolled AlgiPharma AS
RandomizedCrossoverQuadruple-blindTreatment

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.

Timeline

Start
2011-05
Primary completion
2013-10
Completion
2013-11

Drugs

EvaluationDrugModalityDoseRoute
Subject OligoG Other / unclassified 6 % Inhaled

Indications