Clinical Efficacy and Safety of gpASIT+TM to Treat Seasonal Allergic Rhinoconjunctivitis

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
BioTech Tools S.A.
ClinicalTrials.gov Identifier:
NCT01308021
First received: February 28, 2011
Last updated: May 23, 2014
Last verified: May 2014
  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.


Condition Intervention Phase
Grass Pollen Allergy
Hay Fever
Biological: gpASIT+TM
Biological: Placebo
Phase 2

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

Resource links provided by NLM:


Further study details as provided by BioTech Tools S.A.:

Primary Outcome Measures:
  • Impact of gpASIT+TM on the clinical efficacy of the subjects [ Time Frame: grass pollen season 2011 (April to July) ] [ Designated as safety issue: No ]
    The following parameter will be assessed: rhinoconjunctivitis total symptom score


Secondary Outcome Measures:
  • Clinical tolerability and safety of the treatment [ Time Frame: 8 months ] [ Designated as safety issue: Yes ]
    The following parameters will be assessed: general physical status, vital signs, haematological parameters, general blodd biochemistry parameters, all (serious) adverse events, immunological analysis (total IgG, IgE) and inflammatory parameters (CRP, sedimentation rate)

  • Impact of gpASIT+TM on the immunological status of the subjects [ Time Frame: screening visit (January-February 2011), before pollen season (April 2011), during pollen season (June 2011) and after pollen season (August 2011) ] [ Designated as safety issue: No ]
    The following parameter will be assessed: allergen-specific immunoglobulin concentrations

  • Impact of gpASIT+TM on the clinical status of the subjects [ Time Frame: grass pollen season 2011 (April-July) ] [ Designated as safety issue: No ]
    The average daily symptom and rescue medication scores will be assessed.

  • Impact of gpASIT+TM on the quality of life of the subjects [ Time Frame: grass pollen season 2011 (April-July) ] [ Designated as safety issue: No ]
    The quality of life will be assessed by the use of validated questionnaires.


Enrollment: 202
Study Start Date: December 2010
Study Completion Date: December 2011
Primary Completion Date: October 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: gpASIT400
gpASIT+TM 400 µg
Biological: gpASIT+TM
entero-coated capsules containing 400µg of gpASIT+TM, daily , 28 days
Experimental: gpASIT800
gpASIT+TM 800 µg
Biological: gpASIT+TM
entero-coated capsules containing 800 µg of gpASIT+TM, daily, 28 days
Placebo Comparator: Placebo Biological: Placebo
Placebo entero-coated capsules

  Eligibility

Ages Eligible for Study:   18 Years to 50 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01308021

Locations
Belgium
CHR Saint Joseph Warquignies
Boussu, Belgium, 7300
AZ Sint Lucas
Brugge, Belgium, 8310
UZ Brussel
Brussels, Belgium, 1090
UCL Saint Luc
Brussels, Belgium, 1200
Clinique du Parc Léopold
Brussels, Belgium, 1040
UZ Antwerpen
Edegem, Belgium, 2650
UZ Gent
Gent, Belgium, 9000
UZ Leuven
Leuven, Belgium, 3000
CHR Citadelle
Liège, Belgium, 4000
CHU Sart-Tilman
Liège, Belgium, 4000
CHU Ambroise Paré
Mons, Belgium, 7000
UCL Mont Godinne
Yvoir, Belgium, 5530
France
Hôpital Saint Vincent de Paul
Lille, France, 59020
CHRU Lille
Lille, France, 59037
Private practice
Nantes, France, 44000
Private practice
Nantes, France, 44400
CHU Reims
Reims, France, 51100
CHRU Strasbourg
Strasbourg, France, 67091
Luxembourg
CH Luxembourg
Luxembourg, Luxembourg, 1210
Sponsors and Collaborators
BioTech Tools S.A.
Investigators
Principal Investigator: Claus Bachert, MD UZ Ghent
Principal Investigator: Jan Ceuppens, MD UZ Leuven
Principal Investigator: Didier Ebo, MD UZ Antwerpen
Principal Investigator: Jean-Luc Halloy, MD CHR Warquignies
Principal Investigator: Stijn Hallewyck, MD UZ Brussel
Principal Investigator: Peter Hellings, MD UZ Leuven
Principal Investigator: Renaud Louis, MD CHU Liège
Principal Investigator: Catherine Mbasoa, MD Clinique du Parc Léopold Bruxelles
Principal Investigator: Charles Pilette, MD UCL Saint Luc Bruxelles
Principal Investigator: Hélène Simonis, MD CHR Citadelle Liège
Principal Investigator: Olivier Vandenplas, MD UCL Mont Godinne Yvoir
Principal Investigator: Christoph Verhoye, MD AZ Sint-Lucas Brugge
Principal Investigator: Patricia Wackenier, MD CHU Ambroise Paré Mons
Principal Investigator: Frédéric De Blay, MD CHRU Strasbourg
Principal Investigator: Marie-Christine Castelain, MD Hôpital Saint Vincent de Paul Lille
Principal Investigator: François Lavaud, MD CHRU Reims
Principal Investigator: Benoît Wallaert, MD CHU Lille
Principal Investigator: François Wessel, MD Private Practice Nantes
Principal Investigator: Bruno Lebeaupin, MD Private Practice Nantes
Principal Investigator: François Hentges, MD CHL Luxembourg
Principal Investigator: François Durand Perdriel, MD Private Practice Nantes
Principal Investigator: François Spirlet, MD CH de Dinant
  More Information

No publications provided

Responsible Party: BioTech Tools S.A.
ClinicalTrials.gov Identifier: NCT01308021     History of Changes
Other Study ID Numbers: BTT-gpASIT005
Study First Received: February 28, 2011
Last Updated: May 23, 2014
Health Authority: Belgium: Federal Agency for Medicinal Products and Health Products
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Luxembourg: Ministère de la Santé

Keywords provided by BioTech Tools S.A.:
Rhinoconjunctivitis
Allergy
Grass pollen
Hypersensitivity
Immune system disorder

Additional relevant MeSH terms:
Conjunctivitis
Rhinitis, Allergic, Seasonal
Hypersensitivity
Conjunctival Diseases
Eye Diseases
Rhinitis
Nose Diseases
Respiratory Tract Diseases
Respiratory Hypersensitivity
Otorhinolaryngologic Diseases
Hypersensitivity, Immediate
Immune System Diseases

ClinicalTrials.gov processed this record on September 18, 2014