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