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Clinical Efficacy, Immunogenicity, Clinical Tolerability and Assessment of Safety of gpASIT+TM Administered Orally, According to Two Administration Schedules, for the Prophylaxis of Seasonal Grass Pollen Rhinoconjunctivitis

This study is currently Recruiting

March 2011 By BioTech Tools S.A.

First Recieved on February 28, 2011

Last Updated on March 2, 2011

Sponsor: BioTech Tools S.A.
Collaborators:
Information provided by: BioTech Tools S.A.
Identifier: NCT01308021

Purpose

The purpose of the study is to evaluate the efficacy and safety of grass pollen-derived peptides administrated orally to treat seasonal allergic rhinoconjunctivitis.

Study Type: Interventional
Study Design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Prevention

Eligibility

Ages Eligible for Study:18 Years
Genders Eligible for Study:Both
Accepts Healthy Volunteers:No
Criteria

Inclusion Criteria: - Age between 18 and 50 years - Subject has given written informed consent - The subjects are in good physical and mental health according to his/her medical history, vital signs, and clinical status - Male or non pregnant, non-lactating female - Female unable to bear children must have documentation of such in the CRF (i.e. tubule ligation, hysterectomy, or post menopausal (defined as a minimum of one year since the last menstrual period)) - Allergy > 2 years Exclusion Criteria: - Subjects with current immunotherapy or subjects who underwent a previous immunotherapy within the last 2 years - Subjects with perennial asthma - Subjects with a VC < 80% and FEV1 < 70% - Subjects requiring controller medication against asthma (bronchodilator nebulised drugs or local or systemic corticosteroids) - Documented evidence of chronic sinusitis (as determined by investigator) - Subjects with a history of hepatic or renal disease - Subjects symptomatic to perennial inhalant allergens - Subject with malignant disease, autoimmune disease - Female subjects who are pregnant, lactating, or of child-bearing potential and not protected from pregnancy by a sufficiently reliable method (OCs, IUD, ...) - Any chronic disease, which may impair the subject's ability to participate in the trial (i.e. severe congestive heart failure, active gastric ulcer, inflammatory bowel disease, uncontrolled diabetes mellitus, etc?) - Subjects requiring beta-blockers medication - Chronic use of concomitant medications that would affect assessment of the effectiveness of the trial medication (e.g. tricyclic antidepressants) - Subject with febrile illness (> 37.5?C, oral) - A known positive serology for HIV-1/2, HBV or HCV - The subject is immunocompromised by medication or illness, has received a vaccine, corticoids or immunosuppressive medications within 1 month before trial entry - Receipt of blood or a blood derivative in the past 6 months preceding trial entry - Regular consumption of corticoids (oral, topic or nasal) or of anti-histaminic drugs within 4 weeks preceding the trial - Any consumption of corticoids (oral, topic or nasal) or of anti-histaminic drugs within 1 week preceding the trial - Use of long-acting antihistamines - Any condition which could be incompatible with protocol understanding and compliance - Subjects who have forfeited their freedom by administrative or legal award or who are under guardianship - Unreliable subjects including non-compliant subjects, subjects with known alcoholism or drug abuse or with a history of a serious psychiatric disorder as well as subjects unwilling to give informed consent or to abide by the requirements of the protocol - Participation in another clinical trial and/or treatment with an experimental drug within the last 2 years - A history of hypersensitivity to the excipients - Rhinitis medicamentosa, non-specific rhinitis (to food dye, preservative agent?) - Subjects without means of contacting the investigator rapidly in case of emergency, or not able to be contacted rapidly by the investigator

Investigators

  • Investigator: Claus Bachert, MD - Principal Investigator - UZ Ghent
  • Investigator: Jan Ceuppens, MD - Principal Investigator - UZ Leuven
  • Investigator: Didier Ebo, MD - Principal Investigator - UZ Antwerpen
  • Investigator: Jean-Luc Halloy, MD - Principal Investigator - CHR Warquignies
  • Investigator: Stijn Hallewyck, MD - Principal Investigator - UZ Brussel
  • Investigator: Peter Hellings, MD - Principal Investigator - UZ Leuven
  • Investigator: Renaud Louis, MD - Principal Investigator - CHU Li?ge
  • Investigator: Catherine Mbasoa, MD - Principal Investigator - Clinique du Parc L?opold Bruxelles
  • Investigator: Charles Pilette, MD - Principal Investigator - UCL Saint Luc Bruxelles
  • Investigator: H?l?ne Simonis, MD - Principal Investigator - CHR Citadelle Li?ge
  • Investigator: Olivier Vandenplas, MD - Principal Investigator - UCL Mont Godinne Yvoir
  • Investigator: Christoph Verhoye, MD - Principal Investigator - AZ Sint Lucas Brugge
  • Investigator: Patricia Wackenier, MD - Principal Investigator - CHU Ambroise Par? Mons
  • Investigator: Fr?d?ric De Blay, MD - Principal Investigator - CHRU Strasbourg
  • Investigator: Marie-Christine Castelain, MD - Principal Investigator - H?pital Saint Vincent de Paul Lille
  • Investigator: Fran?ois Lavaud, MD - Principal Investigator - CHRU Reims
  • Investigator: Beno?t Wallaert, MD - Principal Investigator - CHU Lille
  • Investigator: Fran?ois Wessel, MD - Principal Investigator - Private Practice Nantes
  • Investigator: Bruno Lebeaupin, MD - Principal Investigator - Private Practice Nantes
  • Investigator: Fran?ois Hentges, MD - Principal Investigator - CHL Luxembourg
  • Investigator: Fran?ois Durand Perdriel, MD - Principal Investigator - Private Practice Nantes
  • Investigator: Fran?ois Spirlet, MD - Principal Investigator - CH de Dinant

Locations

  • CHR Saint Joseph Warquignies

    Boussu, 7300 Belgium

  • AZ Sint Lucas

    Brugge, 8310 Belgium

  • UZ Brussel

    Brussels, 1090 Belgium

  • UCL Saint Luc

    Brussels, 1200 Belgium

  • Clinique du Parc L?opold

    Brussels, 1040 Belgium

  • UZ Antwerpen

    Edegem, 2650 Belgium

  • UZ Gent

    Gent, 9000 Belgium

  • UZ Leuven

    Leuven, 3000 Belgium

  • CHR Citadelle

    Li?ge, 4000 Belgium

  • CHU Sart-Tilman

    Li?ge, 4000 Belgium

  • CHU Ambroise Par?

    Mons, 7000 Belgium

  • UCL Mont Godinne

    Yvoir, 5530 Belgium

  • H?pital Saint Vincent de Paul

    Lille, 59020 France

  • CHRU Lille

    Lille, 59037 France

  • Private practice

    Nantes, 44000 France

  • Private practice

    Nantes, 44400 France

  • CHU Reims

    Reims, 51100 France

  • CHRU Strasbourg

    Strasbourg, 67091 France

  • CH Luxembourg

    Luxembourg, 1210 Luxembourg

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