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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01455675
Other study ID # PsAer-IgY
Secondary ID
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
Health authority
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)

Study Design


Related Conditions & MeSH terms


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
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