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

• Register: ClinicalTrials.gov
• Last refreshed on: 16 December 2017
• Main ID: NCT01455675
• Date of registration: 18/10/2011
• Prospective Registration: No
• Primary sponsor: Mukoviszidose Institut gGmbH
• Public title: Efficacy Study of IgY (Antibody Against Pseudomonas) in Cystic Fibrosis Patients PsAer-IgY
• Scientific 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
• Date of first enrolment: October 2011
• Target sample size: 164
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT01455675
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Prevention. Masking: Double (Participant, Investigator).
• Phase: Phase 3

Countries of recruitment

Austria, Belgium, Germany, Hungary, Ireland, Italy, Poland, Spain, Sweden

Contacts

• Name: Antje Schuster, Prof. Dr.
• Affiliation: Universitätsklinikum Düsseldorf

Key inclusion & exclusion criteria

Inclusion Criteria:

- CF patients diagnosed according to specific clinical features and either a positive
sweat chloride in double proofs or presence of disease-associated CFTR mutations in
both 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 to
Knudson formula)

- CF patients who have had one to several sputum or throat cough swabs or endolaryngeal
suction cultures positive for PA within the last three years and for whom PA has been
successfully eradicated.

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

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

- Subjects of child bearing potential and who are sexually active must meet the
contraception requirements (i.e. oral or injectable contraceptives, intrauterine
devices, double-barrier method, contraceptive patch, male partner sterilization or
condoms).

Exclusion Criteria:

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

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

- History of allergy/hypersensitivity to hens' egg proteins (including medication
allergy) that is deemed relevant to the trial by the investigator. "Relevance" in this
context 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 before
inclusion.

- Clinically relevant diseases or medical conditions other than CF or CF-related
conditions that, in the opinion of the investigator, would compromise the safety of
the 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 to
inclusion).

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

- The patient is an employee of the investigator or the institution with direct
involvement in the trial or other trials under the direction of the investigator or
their members.

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



Age minimum: 5 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Cystic Fibrosis

Intervention(s)

Drug: Placebo

Drug: IgY

Primary Outcome(s)

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]

Secondary Outcome(s)

• Change in FEV 1.0 from day 0 to each visit [Time Frame: max. 24 months]

• Sputum or throat cough swab or endolaryngeal suction cultures for bacteria and fungi [Time Frame: max. 24 months]

• Number of exacerbations [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]

• Control of use of antibiotics, especially anti-pseudomonas antibiotics -measured as days with antibiotic treatment [Time Frame: max. 24 months]

• Change in BMI from day 0 to each visit [Time Frame: max. 24 months]

• Good tolerability and comparable number and quality of adverse events like placebo group [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]

Secondary ID(s)

PsAer-IgY

Source(s) of Monetary Support

Please refer to primary and secondary sponsors