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

NCT01455675 | Completed Phase 3 DMC

• 1 other identifier: PsAer-IgY
• Study Type: interventional
• Target: 164
• Locations: 9 countries
• Sites: 42

Brief Summary

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

Conditions

Cystic Fibrosis

Keywords

cystic fibrosis

Outcome Measures

Primary Outcomes (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

  max. 24 months

Secondary Outcomes (8)

• • Change in FEV 1.0 from day 0 to each visit

  max. 24 months

• • Change in BMI from day 0 to each visit

  max. 24 months

• • Number of exacerbations

  max. 24 months

• • Number of days of illness in hospital and at home, i.e. out of school or work

  max. 24 months

• • Control of use of antibiotics, especially anti-pseudomonas antibiotics -measured as days with antibiotic treatment

  max. 24 months

Study Arms (2)

IgY, gargling solution

EXPERIMENTAL

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

Drug: IgY

Placebo, gargling solution

PLACEBO COMPARATOR

70 ml gargling solution without antibodies, once daily

Drug: Placebo

Interventions

IgY DRUG

Avian polyclonal anti-pseudomonas antibodies (IgY)

Also known as: PsAer-IgY

IgY, gargling solution

Placebo DRUG

Placebo, 70 ml gargling solution, once daily

Placebo, gargling solution

Eligibility Criteria

• Age: 5 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Mukoviszidose Institut gGmbH: lead

Study Sites (42)

Medizinische Universität Innsbruck Department für Kinderheilkunde, Päd III CF Zentrum

Innsbruck, 6020, Austria

Location

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

Salzburg, 5020, Austria

Location

Clinic of Pediatric Respiratory Diseases, Infectious Diseases and Travel Clinic

Brussels, 1090, Belgium

Location

Hôpital Universitaire Erasme, Service de Pneumologie

Brussels, Belgium

Location

University Hospital Leuven, Kindergeneeskunde

Leuven, 3000, Belgium

Location

Charité, Christiane Herzog Zentrum

Berlin, 13353, Germany

Location

Klinikum der Ruhr Universität Bochum

Bochum, 44791, Germany

Location

Universitätsklinik Köln

Cologne, 50924, Germany

Location

University Dresden

Dresden, 01307, Germany

Location

Universitätsklinikum Düsseldorf

Düsseldorf, 40225, Germany

Location

Universitätsklinikum Essen

Essen, 45122, Germany

Location

Klinikum der Johann-Wolfgang- Goethe Universität Frankfurt

Frankfurt, Germany

Location

Universitätsklinikum Freiburg, Zentrum für Kinder- und Jugendmedizin

Freiburg im Breisgau, 79106, Germany

Location

Universitätsklinikum Gießen und Marburg GmbH

Giessen, 35392, Germany

Location

MH Hannover (adults)

Hanover, 30625, Germany

Location

MH Hannover (children)

Hanover, 30625, Germany

Location

Universitätsklinik Jena, Mukoviszidosezentrum

Jena, 07740, Germany

Location

Städtisches Krankenhaus Kiel GmbH

Kiel, 24116, Germany

Location

Universitätsklinikum Mainz

Mainz, 55131, Germany

Location

Universitätsklinik Tübingen

Tübingen, 72076, Germany

Location

Universitäts-Kinderklinik Würzburg

Würzburg, 97080, Germany

Location

Heim Pal Hospital for Children

Budapest, 1089, Hungary

Location

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

Budapest, 1121, Hungary

Location

Cork University Hospital

Cork, Ireland

Location

Our Lady´s Children´s Hospital

Dublin, 12, Ireland

Location

Tallagh Hospital

Dublin, 24, Ireland

Location

Mid-Western Regional Hospital

Limerick, Ireland

Location

Centro Regionale Toscano di Riferimento per la Fibrosi Cistica

Florence, 50139, Italy

Location

Istituto Ospedale Giannina Gaslini

Genova, 16100, Italy

Location

Centro Regionale Fibrosi Cisica Lazio

Roma, 00161, Italy

Location

Azienda Ospedaliera Universitaria Integrata di Verona

Verona, 37126, Italy

Location

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

Gdansk, 80-308, Poland

Location

Centrum Medyczne Karpacz Spólka Akcyjna

Karpacz, 58-540, Poland

Location

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

Lodz, 90-329, Poland

Location

NZOZ Sanatorium Cassia Villa Medica

Rabka-Zdrój, 34-700, Poland

Location

Instytut Matki i Dziecka Zaklad Mukowiscydozy

Warsaw, 01-211, Poland

Location

Hospital Universitario Cruces Neumologia, Pediatric pulmonology

Barakaldo (Vizcaya), 48903, Spain

Location

Passeig Vall d´Hebron 119

Barcelona, 08035, Spain

Location

Hospital Infantil la Paz Sección de Neumologia Pediátrica

Madrid, 28046, Spain

Location

Hospital Materno-Infantil Servicio de Pediatria

Málaga, 29011, Spain

Location

Karolinska University Hospital, Huddinge - CF-Centre

Stockholm, 141 86, Sweden

Location

Uppsala University Childrens Hospital, Akademiska sjukhuset, CF center

Uppsala, 75185, Sweden

Location

Related Links

• Information about the IMPACTT project IgY-study is part of

MeSH Terms

Conditions

Cystic Fibrosis

Interventions

IgY

Condition Hierarchy (Ancestors)

Pancreatic Diseases; Digestive System Diseases; Lung Diseases; Respiratory Tract Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Infant, Newborn, Diseases

Study Officials

• Antje Schuster, Prof. Dr.

  University Düsseldorf

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 18, 2011
• First Posted: October 20, 2011
• Study Start: October 1, 2011
• Primary Completion: June 27, 2017
• Study Completion: June 27, 2017
• Last Updated: July 6, 2017

Record last verified: 2017-07

Locations

DE (16); HU (2); AU (2); SE (2); PL (5); IT (4); ES (4); IE (4); BE (3)