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).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Enrollment
164
Time from start of treatment (=Day 0) to the first recurrence of PA (Pseudomonas aeruginosa) in the sputum or throat cough swab or endolaryngeal suction
Time frame: max. 24 months
• Change in FEV 1.0 from day 0 to each visit
Time frame: max. 24 months
• Change in BMI from day 0 to each visit
Time frame: max. 24 months
• Number of exacerbations
Time frame: max. 24 months
• Number of days of illness in hospital and at home, i.e. out of school or work
Time frame: max. 24 months
• Control of use of antibiotics, especially anti-pseudomonas antibiotics -measured as days with antibiotic treatment
Time frame: max. 24 months
• Change in values of serologic tests for PA precipitins from day 0 to each visit (if applicable)
Time frame: max. 24 months
• Good tolerability and comparable number and quality of adverse events like placebo group
Time frame: max. 24 months
• Sputum or throat cough swab or endolaryngeal suction cultures for bacteria and fungi
Time frame: max. 24 months
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Medizinische Universität Innsbruck Department für Kinderheilkunde, Päd III CF Zentrum
Innsbruck, Austria
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