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

NCT ID: NCT00833066

Last Updated: 2011-11-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 54 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-02-28
• Study Completion Date: 2009-11-30

Brief Summary

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.

Conditions

Seasonal Allergic Rhinoconjunctivitis

Keywords

hay fever; grass pollen allergy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Placebo

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: BIOLOGICAL

placebo entero-coated capsules

gpASIT 25

Group Type: EXPERIMENTAL

gpASIT+TM

Intervention Type: BIOLOGICAL

entero-coated capsules containing 25µg of gpASIT+TM

gpASIT 100

Group Type: EXPERIMENTAL

gpASIT+TM

Intervention Type: BIOLOGICAL

entero-coated capsules containing 100µg of gpASIT+TM

gpASIT 400

Group Type: EXPERIMENTAL

gpASIT+TM

Intervention Type: BIOLOGICAL

entero-coated capsules containing 400µg of gpASIT+TM

Interventions

gpASIT+TM

entero-coated capsules containing 25µg of gpASIT+TM

Intervention Type: BIOLOGICAL

Placebo

placebo entero-coated capsules

Intervention Type: BIOLOGICAL

gpASIT+TM

entero-coated capsules containing 100µg of gpASIT+TM

Intervention Type: BIOLOGICAL

gpASIT+TM

entero-coated capsules containing 400µg of gpASIT+TM

Intervention Type: BIOLOGICAL

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

BioTech Tools S.A.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

University Hospital Brugmann

Brussels, , Belgium

University Hospital Ghent

Ghent, , Belgium

University Hospital Gasthuisberg

Leuven, , Belgium

University Hospital Sart Tilman

Liège, , Belgium

Countries

Belgium

Other Identifiers

EudraCT 2008-006369-10

Identifier Type: -

Identifier Source: secondary_id

BTT-gpASIT003

Identifier Type: -

Identifier Source: org_study_id