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

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Status and phase

Completed

Phase 1

Conditions

Seasonal Allergic Rhinoconjunctivitis

Treatments

Biological: gpASIT+TM

Study type

Interventional

Funder types

Industry

Identifiers

NCT00813046

BTT-gpASIT002

EudraCT 2008-006368-12

Details and patient eligibility

About

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.

Enrollment

8 patients

Sex

All

Ages

18 to 50 years old

Volunteers

No Healthy Volunteers

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