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Efficacy Study of IgY (Antibody Against Pseudomonas) in Cystic Fibrosis Patients — PsAer-IgY  

Cystic Fibrosis Clinical Trial

Official title:
Phase III Study to Evaluate Clinical Efficacy and Safety of Avian Polyclonal Anti-Pseudomonas Antibodies (IgY) in Prevention of Recurrence of Pseudomonas Aeruginosa Infection in Cystic Fibrosis Patients

Clinical Trial Summary

The purpose of this study is to prolong the time to reinfection with Pseudomonas aeruginosa after successfully treated acute or intermittent infection.

Clinical Trial Description

This is a double -blind, placebo controlled study in which the investigational drug and the reference placebo group are gargled and swallowed. 70 ml IgY/ placebo solution is gargled every night for two minutes (for maximal 24 months) The design will include the recruitment of 144 patients randomized in two groups (72 per treatment group) In order to compensate for dropouts (i.e. patients dropping out prior to 24 months without having an event) the total sample size was planned to be approximately 180 (i.e. ~20 % dropout rate). After the actual drop-out rate has been low throughout the study, only 144 plus approx. 10% potential drop-outs were included into the study.

During the two years of treatment, subjects will be examined at the clinic every 3 months regarding safety and efficacy of the medication.

For more information please see www.impactt.eu The IMPACTT Project is funded by EU within the Framework 7 Program. PsAer-IgY Studies is part of IMPACTT Project (Workpackage 2). ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT01455675
Study type Interventional
Source Mukoviszidose Institut gGmbH
Contact
Status Completed
Phase Phase 3
Start date October 2011
Completion date June 27, 2017
View Details
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