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

Inclusion Criteria:

• CF patients diagnosed according to specific clinical features and either a positivesweat chloride in double proofs or presence of disease-associated CFTR mutations inboth alleles

• Males and females 5 years of age and above (being able to gargle)

• CF patients having a FEV1 value between 50% and 130% of predicted value (according toKnudson formula)

• CF patients who have had one to several sputum or throat cough swabs or endolaryngealsuction cultures positive for PA within the last three years and for whom PA has beensuccessfully eradicated.

• Sputum / throat cough swab/ endolaryngeal suction culture negative for PA and othergram-negative bacteria on study entry.

• Patients and/ or their legal representative who are willing and able to give informedconsent/ assent to participate in the study after thorough information

• Subjects of child bearing potential and who are sexually active must meet thecontraception requirements (i.e. oral or injectable contraceptives, intrauterinedevices, double-barrier method, contraceptive patch, male partner sterilization orcondoms).

Exclusion Criteria:

• Microbiologic or serologic evidence of chronic infection with PA. Definition ofchronic PA infection: Three cultures (sputum or throat cough swabs or endolaryngealsuction) have been positive for PA for 6 consecutive months (at least 3 cultures haveto be taken) or more, .

• Patients, who have positive sputum culture or throat cough swab or endolaryngealsuction culture for gram-negative bacteria, such as PA, S. maltophilia, B. cepacia, A.xylosoxidans (eradication before entry in study is possible), Patients, who havepositive sputum culture or throat cough swab or endolaryngeal suction culture foratypical Mycobacteria and / or Aspergillus fumigates, associated with clinicalsymptoms that may necessitate specific treatment.

• History of allergy/hypersensitivity to hens' egg proteins (including medicationallergy) that is deemed relevant to the trial by the investigator. "Relevance" in thiscontext refers to any increased risk of hypersensitivity reaction to trial medication.

• Patient with a known relevant substance abuse, including alcohol or drug abuse.

• Start of a new concomitant or chronic medication for CF within 4 weeks beforeinclusion.

• Clinically relevant diseases or medical conditions other than CF or CF-relatedconditions that, in the opinion of the investigator, would compromise the safety ofthe patient or the quality of the data. This includes, but is not limited to,significant hematological, hepatic, renal, cardiovascular, and neurological diseases (diabetic patients may participate if their disease is under good control prior toinclusion).

• Participation in another study with an investigational drug within one month or 6half-lives (whichever is greater) preceding the inclusion.

• The patient is an employee of the investigator or the institution with directinvolvement in the trial or other trials under the direction of the investigator ortheir members.

• Patients who are pregnant cannot be included into the study. This will be tested atinclusion visit with a urine pregnancy test (in female patients older than 10 yearswith secondary sexual characteristics)