Safety and Tolerance Study of Grass Pollen-derived Peptides to Treat Allergic Rhinitis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00813046
Recruitment Status : Completed
First Posted : December 22, 2008
Last Update Posted : May 26, 2014
Information provided by (Responsible Party):
BioTech Tools S.A.

Brief Summary:
The purpose of this study is to determine whether the oral administration of grass pollen peptides to treat allergic rhinitis is safe and well tolerated.

Condition or disease Intervention/treatment Phase
Seasonal Allergic Rhinoconjunctivitis Biological: gpASIT+TM Phase 1

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 8 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Preliminary Assessment of the Short Term Clinical Tolerability and Safety of Grass Pollen-derived Peptides for Oral Use in Antigen-specific Immunotherapy of Seasonal Allergic Rhinoconjunctivitis
Study Start Date : December 2008
Actual Primary Completion Date : January 2009
Actual Study Completion Date : January 2009

Arm Intervention/treatment
Experimental: gpASIT+TM Biological: gpASIT+TM
oral administration of entero-coated capsules containing increasing doses of gpASIT+TM (25 to 1600µg), one dose per day for 4 days

Primary Outcome Measures :
  1. To demonstrate the clinical tolerability and safety of the treatment by looking at the absence of immediate allergic reaction. [ Time Frame: 10 days ]

Secondary Outcome Measures :
  1. vital signs clinical laboratory evaluations adverse events general physical status [ Time Frame: 10 days ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • 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 females
  • A history of seasonal allergic rhinoconjunctivitis (SAR) during the grass pollen season during at least the last two years
  • A positive skin prick test 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 for SAR
  • 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 food allergy and consecutive anaphylaxis
  • Subjects with a history of hepatic or renal disease
  • 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).
  • Females unable to bear children must have documentation of such (i.e. tubal ligation, hysterectomy, or post menopausal [defined as a minimum of one year since the last menstrual period])
  • 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 with clinically relevant abnormal QTc intervals of the ECG : QTc > 450 ms for man and > 470 ms for women
  • Subjects requiring beta-blockers medication
  • Chronic use of concomitant medications that would affect assessment of the effectiveness of the study 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 study entry
  • Receipt of blood or a blood derivative in the past 6 months preceding study entry
  • Regular consumption of corticoids (oral, topic or nasal) or of anti-histaminic drugs within 4 weeks preceding the study, any consumption of corticoids (oral, topic or nasal) or of anti-histaminic drugs within 1 week preceding the study
  • 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,
  • Participation in another clinical trial and/or treatment with an experimental drug within 1 month of study start
  • A history of hypersensitivity to the excipients

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00813046

Hospital University Ghent
Ghent, Belgium, 9000
Sponsors and Collaborators
BioTech Tools S.A.

Responsible Party: BioTech Tools S.A. Identifier: NCT00813046     History of Changes
Other Study ID Numbers: BTT-gpASIT002
EudraCT 2008-006368-12
First Posted: December 22, 2008    Key Record Dates
Last Update Posted: May 26, 2014
Last Verified: May 2014

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