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

Cystic Fibrosis Clinical Trial

— PsAer-IgY  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01455675
• Other study ID #: PsAer-IgY
• Status: Completed
• Phase: Phase 3
• First received: October 18, 2011
• Last updated: July 3, 2017
• Start date: October 2011
• Est. completion date: June 27, 2017

Study information

• Verified date: July 2017
• Source: Mukoviszidose Institut gGmbH
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 164
• Est. completion date: June 27, 2017
• Est. primary completion date: June 27, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 5 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Cystic Fibrosis
• Fibrosis
• Pseudomonas Infections

Intervention

Drug:
• IgY
Avian polyclonal anti-pseudomonas antibodies (IgY)
• Placebo
Placebo, 70 ml gargling solution, once daily

Locations

Country	Name	City	State
Austria	Medizinische Universität Innsbruck Department für Kinderheilkunde, Päd III CF Zentrum	Innsbruck
Austria	(SALK) Universitätsklink für Kinder- und Jugendheilkunde, Ambulanz für Allergien und Lungenerkrankungen	Salzburg
Belgium	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
Germany	Charité, Christiane Herzog Zentrum	Berlin
Germany	Klinikum der Ruhr Universität Bochum	Bochum
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
Germany	Universitätsklinikum Gießen und Marburg GmbH	Gießen
Germany	MH Hannover (adults)	Hannover
Germany	MH Hannover (children)	Hannover
Germany	Universitätsklinik Jena, Mukoviszidosezentrum	Jena
Germany	Städtisches Krankenhaus Kiel GmbH	Kiel
Germany	Universitätsklinik Köln	Köln
Germany	Universitätsklinikum Mainz	Mainz
Germany	Universitätsklinik Tübingen	Tübingen
Germany	Universitäts-Kinderklinik Würzburg	Würzburg
Hungary	Heim Pal Hospital for Children	Budapest
Hungary	Országos Korányi TBC és Pulm. Intézet, XIX. J fsz. Kronikus-CF care	Budapest
Ireland	Cork University Hospital	Cork
Ireland	Our Lady´s Children´s Hospital	Dublin
Ireland	Tallagh Hospital	Dublin
Ireland	Mid-Western Regional Hospital	Limerick
Italy	Centro Regionale Toscano di Riferimento per la Fibrosi Cistica	Firenze
Italy	Istituto Ospedale Giannina Gaslini	Genova
Italy	Centro Regionale Fibrosi Cisica Lazio	Roma
Italy	Azienda Ospedaliera Universitaria Integrata di Verona	Verona
Poland	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 Osrodek Pediatryczny im. dr J.Korczaka	Lódz
Poland	NZOZ Sanatorium Cassia Villa Medica	Rabka - Zdrój
Poland	Instytut Matki i Dziecka Zaklad Mukowiscydozy	Warsaw
Spain	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
Sweden	Karolinska University Hospital, Huddinge - CF-Centre	Stockholm
Sweden	Uppsala University Childrens Hospital, Akademiska sjukhuset, CF center	Uppsala

Sponsors (1)

Lead Sponsor	Collaborator
Mukoviszidose Institut gGmbH

Countries where clinical trial is conducted

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

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	• Change in FEV 1.0 from day 0 to each visit		max. 24 months
Secondary	• Change in BMI from day 0 to each visit		max. 24 months
Secondary	• Number of exacerbations		max. 24 months
Secondary	• Number of days of illness in hospital and at home, i.e. out of school or work		max. 24 months
Secondary	• Control of use of antibiotics, especially anti-pseudomonas antibiotics -measured as days with antibiotic treatment		max. 24 months
Secondary	• Change in values of serologic tests for PA precipitins from day 0 to each visit (if applicable)		max. 24 months
Secondary	• Good tolerability and comparable number and quality of adverse events like placebo group		max. 24 months
Secondary	• Sputum or throat cough swab or endolaryngeal suction cultures for bacteria and fungi		max. 24 months

External Links

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