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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
BioTech Tools S.A.
ClinicalTrials.gov Identifier:
NCT00813046
First received: December 19, 2008
Last updated: May 23, 2014
Last verified: May 2014
  Purpose

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 Intervention Phase
Seasonal Allergic Rhinoconjunctivitis
Biological: gpASIT+TM
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: 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

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

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

Secondary Outcome Measures:
  • vital signs clinical laboratory evaluations adverse events general physical status [ Time Frame: 10 days ] [ Designated as safety issue: Yes ]

Enrollment: 8
Study Start Date: December 2008
Study Completion Date: January 2009
Primary Completion Date: January 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  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
  • 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
  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: NCT00813046

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

No publications provided

Responsible Party: BioTech Tools S.A.
ClinicalTrials.gov Identifier: NCT00813046     History of Changes
Other Study ID Numbers: BTT-gpASIT002, EudraCT 2008-006368-12
Study First Received: December 19, 2008
Last Updated: May 23, 2014
Health Authority: Belgium: Federal Agency for Medicinal Products and Health Products

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

ClinicalTrials.gov processed this record on October 23, 2014