Safety Study of Grass Pollen-derived Peptides to Treat Seasonal Allergic Rhinoconjunctivitis

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
BioTech Tools S.A.
ClinicalTrials.gov Identifier:
NCT00833066
First received: January 29, 2009
Last updated: November 16, 2011
Last verified: November 2011
  Purpose

The purpose of this study is to determine whether the oral administration of grass pollen peptides is safe and effective in the treatment of allergic rhinitis.


Condition Intervention Phase
Seasonal Allergic Rhinoconjunctivitis
Biological: gpASIT+TM
Biological: Placebo
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Preliminary Assessment of the Clinical Tolerability, Safety and Immunogenicity of Three Different Doses of Grass Pollen-derived Peptides for Oral Use in Antigen-specific Immunotherapy of Seasonal Allergic Rhinoconjunctivitis

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Evidence of allergic reaction [ Time Frame: within the first 14 days (plus or minus 1 day) ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Immunological assessment [ Time Frame: 9 months ] [ Designated as safety issue: No ]
  • Allergy symptom and medication scores [ Time Frame: grass pollen season 2009 ] [ Designated as safety issue: No ]

Enrollment: 54
Study Start Date: February 2009
Study Completion Date: November 2009
Primary Completion Date: October 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Placebo Biological: Placebo
placebo entero-coated capsules
Experimental: gpASIT 25 Biological: gpASIT+TM
entero-coated capsules containing 25µg of gpASIT+TM
Experimental: gpASIT 100 Biological: gpASIT+TM
entero-coated capsules containing 100µg of gpASIT+TM
Experimental: gpASIT 400 Biological: gpASIT+TM
entero-coated capsules containing 400µg of gpASIT+TM

  Eligibility

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Subject has given written informed consent
  • Age between 18 and 50 years
  • 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:

A history of seasonal allergic rhinoconjunctivitis (SAR) during the grass pollen season during at least the two previous years A positive skin prick test (wheal diameter >= 3 mm) to grass-pollen mixture Specific IgE against grass pollen (RAST class 2 or IgE > 0.7 kU/l) Asymptomatic to perennial inhalant allergens.

Exclusion Criteria:

  • Subjects with current or past immunotherapy (any time in the past)
  • Subjects requiring controller medication against asthma (bronchodilator nebulised drugs or local or systemic corticosteroids)
  • Documented evidence of acute or significant chronic sinusitis (as determined by individual 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 or duodenal ulcer, 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, HBs antigen or anti-HCV antibodies
  • 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 1 month of trial start
  • 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
  • Subjects who participated to trial BTT-gpASIT002
  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: NCT00833066

Locations
Belgium
University Hospital Brugmann
Brussels, Belgium, 1020
University Hospital Ghent
Ghent, Belgium, 9000
University Hospital Gasthuisberg
Leuven, Belgium, 3000
University Hospital Sart Tilman
Liège, Belgium, 4000
Sponsors and Collaborators
BioTech Tools S.A.
  More Information

No publications provided

Responsible Party: BioTech Tools S.A.
ClinicalTrials.gov Identifier: NCT00833066     History of Changes
Other Study ID Numbers: BTT-gpASIT003, EudraCT 2008-006369-10
Study First Received: January 29, 2009
Last Updated: November 16, 2011
Health Authority: Belgium: Federal Agency for Medicinal Products and Health Products

Keywords provided by BioTech Tools S.A.:
hay fever
grass pollen allergy

Additional relevant MeSH terms:
Conjunctivitis, Allergic
Conjunctivitis
Conjunctival Diseases
Eye Diseases
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases

ClinicalTrials.gov processed this record on July 22, 2014