Efficacy Study of IgY (Antibody Against Pseudomonas) in Cystic Fibrosis Patients (PsAer-IgY)
Primary Purpose
Cystic Fibrosis
Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
IgY
Placebo
Sponsored by
About this trial
This is an interventional prevention trial for Cystic Fibrosis focused on measuring cystic fibrosis
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)
Sites / Locations
- Medizinische Universität Innsbruck Department für Kinderheilkunde, Päd III CF Zentrum
- (SALK) Universitätsklink für Kinder- und Jugendheilkunde, Ambulanz für Allergien und Lungenerkrankungen
- Clinic of Pediatric Respiratory Diseases, Infectious Diseases and Travel Clinic
- Hôpital Universitaire Erasme, Service de Pneumologie
- University Hospital Leuven, Kindergeneeskunde
- Charité, Christiane Herzog Zentrum
- Klinikum der Ruhr Universität Bochum
- University Dresden
- Universitätsklinikum Düsseldorf
- Universitätsklinikum Essen
- Klinikum der Johann-Wolfgang- Goethe Universität Frankfurt
- Universitätsklinikum Freiburg, Zentrum für Kinder- und Jugendmedizin
- Universitätsklinikum Gießen und Marburg GmbH
- MH Hannover (adults)
- MH Hannover (children)
- Universitätsklinik Jena, Mukoviszidosezentrum
- Städtisches Krankenhaus Kiel GmbH
- Universitätsklinik Köln
- Universitätsklinikum Mainz
- Universitätsklinik Tübingen
- Universitäts-Kinderklinik Würzburg
- Heim Pal Hospital for Children
- Országos Korányi TBC és Pulm. Intézet, XIX. J fsz. Kronikus-CF care
- Cork University Hospital
- Our Lady´s Children´s Hospital
- Tallagh Hospital
- Mid-Western Regional Hospital
- Centro Regionale Toscano di Riferimento per la Fibrosi Cistica
- Istituto Ospedale Giannina Gaslini
- Centro Regionale Fibrosi Cisica Lazio
- Azienda Ospedaliera Universitaria Integrata di Verona
- Szpital Dzieciecy Polanki im. Macieja Plazynskiego w Gdansku sp Z o.o. Poradnia Leczenia
- Centrum Medyczne Karpacz Spólka Akcyjna
- NZOZ Sanatorium Cassia Villa Medica
- Instytut Matki i Dziecka Zaklad Mukowiscydozy
- Wojewódzki Szpital Specjalistyczny im. M.Kopernika Ośrodek Pediatryczny im. dr J.Korczaka
- Hospital Universitario Cruces Neumologia, Pediatric pulmonology
- Passeig Vall d´Hebron 119
- Hospital Infantil la Paz Sección de Neumologia Pediátrica
- Hospital Materno-Infantil Servicio de Pediatria
- Karolinska University Hospital, Huddinge - CF-Centre
- Uppsala University Childrens Hospital, Akademiska sjukhuset, CF center
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
IgY, gargling solution
Placebo, gargling solution
Arm Description
Avian polyclonal anti-pseudomonas antibodies (IgY), 70 ml gargling solution contains 50 mg IgY with an activity against PA, once daily
70 ml gargling solution without antibodies, once daily
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
• Change in FEV 1.0 from day 0 to each visit
• Change in BMI from day 0 to each visit
• Number of exacerbations
• Number of days of illness in hospital and at home, i.e. out of school or work
• Control of use of antibiotics, especially anti-pseudomonas antibiotics -measured as days with antibiotic treatment
• Change in values of serologic tests for PA precipitins from day 0 to each visit (if applicable)
• Good tolerability and comparable number and quality of adverse events like placebo group
• Sputum or throat cough swab or endolaryngeal suction cultures for bacteria and fungi
Full Information
NCT ID
NCT01455675
First Posted
October 18, 2011
Last Updated
July 3, 2017
Sponsor
Mukoviszidose Institut gGmbH
1. Study Identification
Unique Protocol Identification Number
NCT01455675
Brief Title
Efficacy Study of IgY (Antibody Against Pseudomonas) in Cystic Fibrosis Patients
Acronym
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
Study Type
Interventional
2. Study Status
Record Verification Date
July 2017
Overall Recruitment Status
Completed
Study Start Date
October 2011 (undefined)
Primary Completion Date
June 27, 2017 (Actual)
Study Completion Date
June 27, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Mukoviszidose Institut gGmbH
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cystic Fibrosis
Keywords
cystic fibrosis
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
164 (Actual)
8. Arms, Groups, and Interventions
Arm Title
IgY, gargling solution
Arm Type
Experimental
Arm Description
Avian polyclonal anti-pseudomonas antibodies (IgY), 70 ml gargling solution contains 50 mg IgY with an activity against PA, once daily
Arm Title
Placebo, gargling solution
Arm Type
Placebo Comparator
Arm Description
70 ml gargling solution without antibodies, once daily
Intervention Type
Drug
Intervention Name(s)
IgY
Other Intervention Name(s)
PsAer-IgY
Intervention Description
Avian polyclonal anti-pseudomonas antibodies (IgY)
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo, 70 ml gargling solution, once daily
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
• Change in FEV 1.0 from day 0 to each visit
Time Frame
max. 24 months
Title
• Change in BMI from day 0 to each visit
Time Frame
max. 24 months
Title
• Number of exacerbations
Time Frame
max. 24 months
Title
• Number of days of illness in hospital and at home, i.e. out of school or work
Time Frame
max. 24 months
Title
• Control of use of antibiotics, especially anti-pseudomonas antibiotics -measured as days with antibiotic treatment
Time Frame
max. 24 months
Title
• Change in values of serologic tests for PA precipitins from day 0 to each visit (if applicable)
Time Frame
max. 24 months
Title
• Good tolerability and comparable number and quality of adverse events like placebo group
Time Frame
max. 24 months
Title
• Sputum or throat cough swab or endolaryngeal suction cultures for bacteria and fungi
Time Frame
max. 24 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
5 Years
Accepts Healthy Volunteers
No
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Antje Schuster, Prof. Dr.
Organizational Affiliation
Universitätsklinikum Düsseldorf
Official's Role
Principal Investigator
Facility Information:
Facility Name
Medizinische Universität Innsbruck Department für Kinderheilkunde, Päd III CF Zentrum
City
Innsbruck
ZIP/Postal Code
6020
Country
Austria
Facility Name
(SALK) Universitätsklink für Kinder- und Jugendheilkunde, Ambulanz für Allergien und Lungenerkrankungen
City
Salzburg
ZIP/Postal Code
5020
Country
Austria
Facility Name
Clinic of Pediatric Respiratory Diseases, Infectious Diseases and Travel Clinic
City
Brussels
ZIP/Postal Code
1090
Country
Belgium
Facility Name
Hôpital Universitaire Erasme, Service de Pneumologie
City
Brussels
Country
Belgium
Facility Name
University Hospital Leuven, Kindergeneeskunde
City
Leuven
ZIP/Postal Code
3000
Country
Belgium
Facility Name
Charité, Christiane Herzog Zentrum
City
Berlin
ZIP/Postal Code
13353
Country
Germany
Facility Name
Klinikum der Ruhr Universität Bochum
City
Bochum
ZIP/Postal Code
44791
Country
Germany
Facility Name
University Dresden
City
Dresden
ZIP/Postal Code
01307
Country
Germany
Facility Name
Universitätsklinikum Düsseldorf
City
Düsseldorf
ZIP/Postal Code
40225
Country
Germany
Facility Name
Universitätsklinikum Essen
City
Essen
ZIP/Postal Code
45122
Country
Germany
Facility Name
Klinikum der Johann-Wolfgang- Goethe Universität Frankfurt
City
Frankfurt
Country
Germany
Facility Name
Universitätsklinikum Freiburg, Zentrum für Kinder- und Jugendmedizin
City
Freiburg
ZIP/Postal Code
79106
Country
Germany
Facility Name
Universitätsklinikum Gießen und Marburg GmbH
City
Gießen
ZIP/Postal Code
35392
Country
Germany
Facility Name
MH Hannover (adults)
City
Hannover
ZIP/Postal Code
30625
Country
Germany
Facility Name
MH Hannover (children)
City
Hannover
ZIP/Postal Code
30625
Country
Germany
Facility Name
Universitätsklinik Jena, Mukoviszidosezentrum
City
Jena
ZIP/Postal Code
07740
Country
Germany
Facility Name
Städtisches Krankenhaus Kiel GmbH
City
Kiel
ZIP/Postal Code
24116
Country
Germany
Facility Name
Universitätsklinik Köln
City
Köln
ZIP/Postal Code
50924
Country
Germany
Facility Name
Universitätsklinikum Mainz
City
Mainz
ZIP/Postal Code
55131
Country
Germany
Facility Name
Universitätsklinik Tübingen
City
Tübingen
ZIP/Postal Code
72076
Country
Germany
Facility Name
Universitäts-Kinderklinik Würzburg
City
Würzburg
ZIP/Postal Code
97080
Country
Germany
Facility Name
Heim Pal Hospital for Children
City
Budapest
ZIP/Postal Code
1089
Country
Hungary
Facility Name
Országos Korányi TBC és Pulm. Intézet, XIX. J fsz. Kronikus-CF care
City
Budapest
ZIP/Postal Code
1121
Country
Hungary
Facility Name
Cork University Hospital
City
Cork
Country
Ireland
Facility Name
Our Lady´s Children´s Hospital
City
Dublin
ZIP/Postal Code
12
Country
Ireland
Facility Name
Tallagh Hospital
City
Dublin
ZIP/Postal Code
24
Country
Ireland
Facility Name
Mid-Western Regional Hospital
City
Limerick
Country
Ireland
Facility Name
Centro Regionale Toscano di Riferimento per la Fibrosi Cistica
City
Firenze
ZIP/Postal Code
50139
Country
Italy
Facility Name
Istituto Ospedale Giannina Gaslini
City
Genova
ZIP/Postal Code
16100
Country
Italy
Facility Name
Centro Regionale Fibrosi Cisica Lazio
City
Roma
ZIP/Postal Code
00161
Country
Italy
Facility Name
Azienda Ospedaliera Universitaria Integrata di Verona
City
Verona
ZIP/Postal Code
37126
Country
Italy
Facility Name
Szpital Dzieciecy Polanki im. Macieja Plazynskiego w Gdansku sp Z o.o. Poradnia Leczenia
City
Gdansk
ZIP/Postal Code
80-308
Country
Poland
Facility Name
Centrum Medyczne Karpacz Spólka Akcyjna
City
Karpacz
ZIP/Postal Code
58-540
Country
Poland
Facility Name
NZOZ Sanatorium Cassia Villa Medica
City
Rabka - Zdrój
ZIP/Postal Code
34-700
Country
Poland
Facility Name
Instytut Matki i Dziecka Zaklad Mukowiscydozy
City
Warsaw
ZIP/Postal Code
01-211
Country
Poland
Facility Name
Wojewódzki Szpital Specjalistyczny im. M.Kopernika Ośrodek Pediatryczny im. dr J.Korczaka
City
Łódź
ZIP/Postal Code
90-329
Country
Poland
Facility Name
Hospital Universitario Cruces Neumologia, Pediatric pulmonology
City
Barakaldo (Vizcaya)
ZIP/Postal Code
48903
Country
Spain
Facility Name
Passeig Vall d´Hebron 119
City
Barcelona
ZIP/Postal Code
08035
Country
Spain
Facility Name
Hospital Infantil la Paz Sección de Neumologia Pediátrica
City
Madrid
ZIP/Postal Code
28046
Country
Spain
Facility Name
Hospital Materno-Infantil Servicio de Pediatria
City
Málaga
ZIP/Postal Code
29011
Country
Spain
Facility Name
Karolinska University Hospital, Huddinge - CF-Centre
City
Stockholm
ZIP/Postal Code
141 86
Country
Sweden
Facility Name
Uppsala University Childrens Hospital, Akademiska sjukhuset, CF center
City
Uppsala
ZIP/Postal Code
75185
Country
Sweden
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Efficacy Study of IgY (Antibody Against Pseudomonas) in Cystic Fibrosis Patients
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