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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01455675
Recruitment Status : Completed
First Posted : October 20, 2011
Last Update Posted : July 6, 2017
Information provided by (Responsible Party):
Mukoviszidose Institut gGmbH

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

Condition or disease Intervention/treatment Phase
Cystic Fibrosis Drug: IgY Drug: Placebo Phase 3

Detailed 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 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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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 164 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Prevention
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
Study Start Date : October 2011
Actual Primary Completion Date : June 27, 2017
Actual Study Completion Date : June 27, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cystic Fibrosis

Arm Intervention/treatment
Experimental: IgY, gargling solution
Avian polyclonal anti-pseudomonas antibodies (IgY), 70 ml gargling solution contains 50 mg IgY with an activity against PA, once daily
Drug: IgY
Avian polyclonal anti-pseudomonas antibodies (IgY)
Other Name: PsAer-IgY

Placebo Comparator: Placebo, gargling solution
70 ml gargling solution without antibodies, once daily
Drug: Placebo
Placebo, 70 ml gargling solution, once daily

Primary Outcome Measures :
  1. 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 Measures :
  1. • Change in FEV 1.0 from day 0 to each visit [ Time Frame: max. 24 months ]
  2. • Change in BMI from day 0 to each visit [ Time Frame: max. 24 months ]
  3. • Number of exacerbations [ Time Frame: max. 24 months ]
  4. • Number of days of illness in hospital and at home, i.e. out of school or work [ Time Frame: max. 24 months ]
  5. • Control of use of antibiotics, especially anti-pseudomonas antibiotics -measured as days with antibiotic treatment [ Time Frame: max. 24 months ]
  6. • Change in values of serologic tests for PA precipitins from day 0 to each visit (if applicable) [ Time Frame: max. 24 months ]
  7. • Good tolerability and comparable number and quality of adverse events like placebo group [ Time Frame: max. 24 months ]
  8. • Sputum or throat cough swab or endolaryngeal suction cultures for bacteria and fungi [ Time Frame: max. 24 months ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   5 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01455675

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Sponsors and Collaborators
Mukoviszidose Institut gGmbH
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Principal Investigator: Antje Schuster, Prof. Dr. Universitätsklinikum Düsseldorf
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Responsible Party: Mukoviszidose Institut gGmbH Identifier: NCT01455675    
Other Study ID Numbers: PsAer-IgY
First Posted: October 20, 2011    Key Record Dates
Last Update Posted: July 6, 2017
Last Verified: July 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Keywords provided by Mukoviszidose Institut gGmbH:
cystic fibrosis
Additional relevant MeSH terms:
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Pseudomonas Infections
Cystic Fibrosis
Pathologic Processes
Pancreatic Diseases
Digestive System Diseases
Lung Diseases
Respiratory Tract Diseases
Genetic Diseases, Inborn
Infant, Newborn, Diseases
Gram-Negative Bacterial Infections
Bacterial Infections
Bacterial Infections and Mycoses