clinical efficacy and safety of gpasit+tm to treat seasonal allergic rhinoconjunctivitis

Conditions: Grass Pollen Allergy; Hay Fever

Summary: the purpose of the study is to evaluate the efficacy and safety of grass pollen-derived peptides administrated orally to treat seasonal allergic rhinoconjunctivitis.


Eligibility criteria:
inclusion criteria: * age between 18 and 50 years * subject has given written informed consent * 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 \> 2 years exclusion criteria: * subjects with current immunotherapy or subjects who underwent a previous immunotherapy within the last 2 years * subjects with perennial asthma * subjects with a vc \< 80% and fev1 \< 70% * subjects requiring controller medication against asthma (bronchodilator nebulised drugs or local or systemic corticosteroids) * documented evidence of chronic sinusitis (as determined by 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 ulcer, inflammatory bowel disease, 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, hbv or hcv * 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 the last 2 years * 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

Keywords: rhinoconjunctivitis allergy grass pollen hypersensitivity immune system disorder