Trial document





This trial has been registered retrospectively.
drksid header

  DRKS00004553

Trial Description

start of 1:1-Block title

Title

A randomised, double-blind, placebo-controlled study of oral immunotherapy in peanut allergic children

end of 1:1-Block title
start of 1:1-Block acronym

Trial Acronym

Peanut OIT

end of 1:1-Block acronym
start of 1:1-Block url

URL of the Trial

[---]*

end of 1:1-Block url
start of 1:1-Block public summary

Brief Summary in Lay Language

1-2% of the pediatric population suffers from peanut allergy. In allergic individuals ingestion of small amounts of peanut may lead to severe and potentially life-threatening allergic reactions. There is no current curative therapy. Thus patients have to avoid peanuts very strictly, most of the times all life-long. In the recent past it could be shown that oral immunotherapy seems to be a potential curative approach for peanut allergy. Within the current study peanut-allergic children will be recruited and randomized by chance into two groups. The treatment group receives a chocolat dessert with roasted peanut, the placebo group receives a peanut-free chocolat dessert. Patients have to ingest small increasing amounts of the peanut preparation on a daily basis until they reach a maintenance dose of approximately one peanut. The purpose of this study is to induce a tolerance towards peanuts in the peanut-allergic children and thus to develop a new treatment for peanut allergy.

end of 1:1-Block public summary
start of 1:1-Block scientific synopsis

Brief Summary in Scientific Language

1-2% of the pediatric population suffers from peanut allergy. In allergic individuals ingestion of small amounts of peanut may lead to severe and potentially life-threatening allergic reactions. There is no current curative therapy. Thus patients have to avoid peanuts very strictly, most of the times all life-long. In the recent past it could be shown that oral immunotherapy seems to be a potential curative approach for peanut allergy. With this kind of therapy children receive incremental doses of peanut on a daily basis orally.For this trial, children with peanut allergy will be recruited and randomized 1:1 into either of two groups (treatment group with roasted peanuts or a placebo group; for blinding a chocolate based dessert matrix as a vehicle will be used).
The purpose of this study is to induce a clinical oral desensitization/ tolerance to peanuts in children with IgE-mediated peanut allergy using oral immunotherapy. We will compare the number of patients in both groups, who tolerate a protective dose of 500mg whole peanut (approximately 1 peanut) or more at final challenge after the study. Additionally changes concerning intra-individual threshold-levels will be measured and compared in both groups. Moreover, immunological mechanisms involved in tolerance development as well as a changes in quality of life will be evaluated.

end of 1:1-Block scientific synopsis
start of 1:1-Block forwarded Data

Do you plan to share individual participant data with other researchers?

[---]*

end of 1:1-Block forwarded Data
start of 1:1-Block forwarded Data Content

Description IPD sharing plan:

[---]*

end of 1:1-Block forwarded Data Content
start of 1:1-Block organizational data

Organizational Data

  •   DRKS00004553
  •   2013/07/31
  •   [---]*
  •   yes
  •   Approved
  •   EA2/075/08, Ethik-Kommission der Charité -Universitätsmedizin Berlin-
end of 1:1-Block organizational data
start of 1:n-Block secondary IDs

Secondary IDs

  • [---]*
end of 1:n-Block secondary IDs
start of 1:N-Block indications

Health Condition or Problem studied

  •   T78.1 -  Other adverse food reactions, not elsewhere classified
  •   T78.0 -  Anaphylactic shock due to adverse food reaction
end of 1:N-Block indications
start of 1:N-Block interventions

Interventions/Observational Groups

  •   At study entry all patients undergo an oral food challenge to peanut. Children of the Verum-group receive samll amounts of a chocolate dessert with peanut flour of roasted peanuts on a daily basis. Initially, a build-up phase is performed for a maximum of 10 months, every two weeks dose increases (quantity of the chocolate dessert) are performed up to a maximum dose of 500 mg or 1000mg of whole peanut which the patients will tolerate. After eight weeks of daily intake of this maintenance dose all children receive another oral food challenge.
  •   At study entry all patients undergo an oral food challenge to peanut. Patients of the Placebo-group receive a small dose of a chocolate dessert whithout roasted peanut on a daily basis-similar to the protocol of the Verum-group.
end of 1:N-Block interventions
start of 1:1-Block design

Characteristics

  •   Interventional
  •   [---]*
  •   Randomized controlled trial
  •   Blinded
  •   patient/subject, investigator/therapist, caregiver, assessor
  •   Placebo
  •   Treatment
  •   Parallel
  •   N/A
  •   N/A
end of 1:1-Block design
start of 1:1-Block primary endpoint

Primary Outcome

Primary outcome will be the comparison between the number of patients in both groups (Placebo/ Verum) who tolerate 500mg of whole peanut or more at final oral challenge after the end of the study (visit 3), after finished oral immunotherapy/Placebo-therapy.

end of 1:1-Block primary endpoint
start of 1:1-Block secondary endpoint

Secondary Outcome

As a secondary outcome the number of patients who will not react to the maximum dose of peanut at final challenge after the end of the study (visit 3) will be compared in both groups (Placebo/ Verum).
Furthermore changes in threshold levels between baseline (visit 1, prior to oral immunotherapy) and final oral peanut challenge (visit 3, post oral immunotherapy) of patients receiving Verum/ Placebo therapy will be compared intraindividually as well as between these two groups.
Total number of objective allergic adverse events per total oral immunotherapy-doses will be compared in patients of the Verum and the placebo group (V1 to V3). In addition the total number of allergic adverse events requiring medical intervention per total oral immunotherapy-doses will be compared in patients of the Verum and the placebo group.
Changes in quality of life and burden of treatment, which will be assessed in all children and their mothers before and after completion of the study (4-5 weeks after visit 3) using the FAQLQ-CF, FAQLQ-TF, FAQLQ-PF- questionnaires and BOT-CF, BOT-TF, BOT-PF- questionnaires respectively, will be evaluated separately and compared in both groups (Verum/Placebo).
Furthermore changes in peanut-specific T-cell and B cell responses and basophil reactivity will be measured in vitro before (visit 1) and after oral immunotherapy-study (visit 3) and both groups will be evaluated separately and compared with each other.

end of 1:1-Block secondary endpoint
start of 1:n-Block recruitment countries

Countries of Recruitment

  •   Germany
end of 1:n-Block recruitment countries
start of 1:n-Block recruitment locations

Locations of Recruitment

  • University Medical Center 
  • Medical Center 
  • University Medical Center 
  • University Medical Center 
  • University Medical Center 
  • University Medical Center 
  • University Medical Center 
end of 1:n-Block recruitment locations
start of 1:1-Block recruitment

Recruitment

  •   Actual
  •   2008/12/10
  •   56
  •   Multicenter trial
  •   National
end of 1:1-Block recruitment
start of 1:1-Block inclusion criteria

Inclusion Criteria

  •   Both, male and female
  •   3   Years
  •   18   Years
end of 1:1-Block inclusion criteria
start of 1:1-Block inclusion criteria add

Additional Inclusion Criteria

Children with
1. a sensitization against peanut (peanut-specific IgE > 0.35 kU/l)
2. challenge-proven clinical relevant peanut allergy
3. signed informed consent by the mother and father of the child
4. mother or father being mentally as well as verbally capable of understanding the
proposed intention and intervention of the study

end of 1:1-Block inclusion criteria add
start of 1:1-Block exclusion criteria

Exclusion Criteria

Children with
1. ongoing treatment of another form of immunotherapy (e.g. systemic or sublingual
immunotherapy against pollen) during the study period
2. participation in another interventional study trial
3. other severe diseases (following the clinical judgement of the study physician)

end of 1:1-Block exclusion criteria
start of 1:n-Block addresses

Addresses

  • start of 1:1-Block address primary-sponsor
    • Klinik für Pädiatrie mit Schwerpunkt Pneumologie und Immunologie Universitätsmedizin Charité Berlin- CVK
    • Ms.  Dr.  Kirsten Beyer,  Katharina Blümchen 
    • Augustenburgerplatz 1
    • 13353  Berlin
    • Germany
    end of 1:1-Block address primary-sponsor
    start of 1:1-Block address contact primary-sponsor
    end of 1:1-Block address contact primary-sponsor
  • start of 1:1-Block address other
    • Altonaer Kinderklinik
    • Mr.  Dr.  Frank  Ahrens 
    • Bleickenallee 38
    • 22763  Hamburg
    • Germany
    end of 1:1-Block address other
    start of 1:1-Block address contact other
    •   0049-40-88908-0
    •   [---]*
    •   [---]*
    •   [---]*
    end of 1:1-Block address contact other
  • start of 1:1-Block address other
    • Kinderklinik München, Schwabing, Klinik für Kinder-und Jugendmedizin der Technischen Universität München
    • Mr.  Dr.  Armin  Grübl 
    • Parzivalstr.16
    • 80804  München
    • Germany
    end of 1:1-Block address other
    start of 1:1-Block address contact other
    •   0049-89-3068-2260
    •   [---]*
    •   [---]*
    •   [---]*
    end of 1:1-Block address contact other
  • start of 1:1-Block address other
    • St.Josef-Hospital, Klinik für Kinder-und Jugendmedizin der Ruhr Universität Bochum
    • Mr.  Prof.Dr.  Eckard  Hamelmann 
    • Alexandrinenstr.5
    • 44791  Bochum
    • Germany
    end of 1:1-Block address other
    start of 1:1-Block address contact other
    •   0049-234-5092611
    •   [---]*
    •   [---]*
    •   [---]*
    end of 1:1-Block address contact other
  • start of 1:1-Block address other
    • Klinik für pädiatrische Pneumologie, Allergologie,Neonatologie, Medizinische Hochschule Hannover
    • Ms.  Prof. Dr.  Gesine  Hansen 
    • Carl-Neuberg-Str.1
    • 30625  Hannover
    • Germany
    end of 1:1-Block address other
    start of 1:1-Block address contact other
    •   0049-511-532-9138
    •   [---]*
    •   [---]*
    •   [---]*
    end of 1:1-Block address contact other
  • start of 1:1-Block address other
    • Zentrum für Kinder-und Jugendmedizin, Universitätsklinik Freiburg
    • Ms.  Prof. Dr.  Andrea  Heinzmann 
    • Mathildenstr.1
    • 79106  Freiburg
    • Germany
    end of 1:1-Block address other
    start of 1:1-Block address contact other
    •   0049-761-27043000
    •   [---]*
    •   [---]*
    •   [---]*
    end of 1:1-Block address contact other
  • start of 1:1-Block address other
    • Klinik für Kinder-und Jugendmedizin, Universitätsklinikum Carl Gustav Carus, Technische Universität Dresden
    • Ms.  Dr.  Katja  Nemat 
    • Fetscherstr.74
    • 01307  Dresden
    • Germany
    end of 1:1-Block address other
    start of 1:1-Block address contact other
    •   0049-351-458-2073
    •   [---]*
    •   [---]*
    •   [---]*
    end of 1:1-Block address contact other
  • start of 1:1-Block address scientific-contact
    • Klinik für Pädiatrie mit Schwerpunkt Pneumologie und Immunologie Universitätsmedizin Charité Berlin- CVK
    • Ms.  Dr.  Katharina  Blümchen 
    • Augustenburgerplatz 1
    • 13353  Berlin
    • Germany
    end of 1:1-Block address scientific-contact
    start of 1:1-Block address contact scientific-contact
    end of 1:1-Block address contact scientific-contact
  • start of 1:1-Block address public-contact
    • Klinik für Pädiatrie mit Schwerpunkt Pneumologie und Immunologie Universitätsmedizin Charité Berlin- CVK
    • Ms.  Dr.  Katharina  Blümchen 
    • Augustenburgerplatz 1
    • 13353  Berlin
    • Germany
    end of 1:1-Block address public-contact
    start of 1:1-Block address contact public-contact
    end of 1:1-Block address contact public-contact
end of 1:n-Block addresses
start of 1:n-Block material support

Sources of Monetary or Material Support

  • start of 1:1-Block address materialSupport
    • Berliner Sparkassenstiftung Medizin
    • Bundesallee 171
    • 10715  Berlin
    • Germany
    end of 1:1-Block address materialSupport
    start of 1:1-Block address contact materialSupport
    •   [---]*
    •   [---]*
    •   [---]*
    •   [---]*
    end of 1:1-Block address contact materialSupport
  • start of 1:1-Block address otherSupport
    • Rahel Hirsch Stipendium Universitätsmedizin Berlin, Charité
    • Charitéplatz 1
    • 10117  Berlin
    • Germany
    end of 1:1-Block address otherSupport
    start of 1:1-Block address contact otherSupport
    •   [---]*
    •   [---]*
    •   [---]*
    •   [---]*
    end of 1:1-Block address contact otherSupport
  • start of 1:1-Block address otherSupport
    • bea, Stiftung zur Behandlung von Ernussallergien
    • Knesebeckstr.16
    • 10623  Berlin
    • Germany
    end of 1:1-Block address otherSupport
    start of 1:1-Block address contact otherSupport
    •   [---]*
    •   [---]*
    •   [---]*
    •   [---]*
    end of 1:1-Block address contact otherSupport
end of 1:n-Block material support
start of 1:1-Block state

Status

  •   Recruiting complete, follow-up complete
  •   2012/08/25
end of 1:1-Block state
start of 1:n-Block publications

Trial Publications, Results and other Documents

  • [---]*
end of 1:n-Block publications
* This entry means the parameter is not applicable or has not been set.