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

NCT ID: NCT01455675

Last Updated: 2017-07-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 164 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-10-31
• Study Completion Date: 2017-06-27

Brief Summary

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

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 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).

Conditions

Cystic Fibrosis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

IgY, gargling solution

Avian polyclonal anti-pseudomonas antibodies (IgY), 70 ml gargling solution contains 50 mg IgY with an activity against PA, once daily

Group Type: EXPERIMENTAL

IgY

Intervention Type: DRUG

Avian polyclonal anti-pseudomonas antibodies (IgY)

Placebo, gargling solution

70 ml gargling solution without antibodies, once daily

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Placebo, 70 ml gargling solution, once daily

Interventions

IgY

Avian polyclonal anti-pseudomonas antibodies (IgY)

Intervention Type: DRUG

Placebo

Placebo, 70 ml gargling solution, once daily

Intervention Type: DRUG

Other Intervention Names

PsAer-IgY

Eligibility 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)

• Minimum Eligible Age: 5 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Mukoviszidose Institut gGmbH

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Antje Schuster, Prof. Dr.

Role: PRINCIPAL_INVESTIGATOR

University Düsseldorf

Locations

Medizinische Universität Innsbruck Department für Kinderheilkunde, Päd III CF Zentrum

Innsbruck, , Austria

(SALK) Universitätsklink für Kinder- und Jugendheilkunde, Ambulanz für Allergien und Lungenerkrankungen

Salzburg, , Austria

Clinic of Pediatric Respiratory Diseases, Infectious Diseases and Travel Clinic

Brussels, , Belgium

Hôpital Universitaire Erasme, Service de Pneumologie

Brussels, , Belgium

University Hospital Leuven, Kindergeneeskunde

Leuven, , Belgium

Charité, Christiane Herzog Zentrum

Berlin, , Germany

Klinikum der Ruhr Universität Bochum

Bochum, , Germany

Universitätsklinik Köln

Cologne, , Germany

University Dresden

Dresden, , Germany

Universitätsklinikum Düsseldorf

Düsseldorf, , Germany

Universitätsklinikum Essen

Essen, , Germany

Klinikum der Johann-Wolfgang- Goethe Universität Frankfurt

Frankfurt, , Germany

Universitätsklinikum Freiburg, Zentrum für Kinder- und Jugendmedizin

Freiburg im Breisgau, , Germany

Universitätsklinikum Gießen und Marburg GmbH

Giessen, , Germany

MH Hannover (adults)

Hanover, , Germany

MH Hannover (children)

Hanover, , Germany

Universitätsklinik Jena, Mukoviszidosezentrum

Jena, , Germany

Städtisches Krankenhaus Kiel GmbH

Kiel, , Germany

Universitätsklinikum Mainz

Mainz, , Germany

Universitätsklinik Tübingen

Tübingen, , Germany

Universitäts-Kinderklinik Würzburg

Würzburg, , Germany

Heim Pal Hospital for Children

Budapest, , Hungary

Országos Korányi TBC és Pulm. Intézet, XIX. J fsz. Kronikus-CF care

Budapest, , Hungary

Cork University Hospital

Cork, , Ireland

Our Lady´s Children´s Hospital

Dublin, , Ireland

Tallagh Hospital

Dublin, , Ireland

Mid-Western Regional Hospital

Limerick, , Ireland

Centro Regionale Toscano di Riferimento per la Fibrosi Cistica

Florence, , Italy

Istituto Ospedale Giannina Gaslini

Genova, , Italy

Centro Regionale Fibrosi Cisica Lazio

Roma, , Italy

Azienda Ospedaliera Universitaria Integrata di Verona

Verona, , Italy

Szpital Dzieciecy Polanki im. Macieja Plazynskiego w Gdansku sp Z o.o. Poradnia Leczenia

Gdansk, , Poland

Centrum Medyczne Karpacz Spólka Akcyjna

Karpacz, , Poland

Wojewódzki Szpital Specjalistyczny im. M.Kopernika Ośrodek Pediatryczny im. dr J.Korczaka

Lodz, , Poland

NZOZ Sanatorium Cassia Villa Medica

Rabka-Zdrój, , Poland

Instytut Matki i Dziecka Zaklad Mukowiscydozy

Warsaw, , Poland

Hospital Universitario Cruces Neumologia, Pediatric pulmonology

Barakaldo (Vizcaya), , Spain

Passeig Vall d´Hebron 119

Barcelona, , Spain

Hospital Infantil la Paz Sección de Neumologia Pediátrica

Madrid, , Spain

Hospital Materno-Infantil Servicio de Pediatria

Málaga, , Spain

Karolinska University Hospital, Huddinge - CF-Centre

Stockholm, , Sweden

Uppsala University Childrens Hospital, Akademiska sjukhuset, CF center

Uppsala, , Sweden

Countries

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

Related Links

http://www.impactt.eu

Information about the IMPACTT project IgY-study is part of

Other Identifiers

PsAer-IgY

Identifier Type: -

Identifier Source: org_study_id