Clinical Drug Experience Knowledgebase

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