seasonal allergic rhinoconjunctivitis
Conditions
Interventions
Product Code: gpASIT+TM 25 µg
Pharmaceutical Form: Gastro-resistant capsule, soft
Other descriptive name: pollen peptides
Concentration unit: µg microgram(s)
Concentration type: equal
Concentration nu
Sponsors
BioTech Tools S.A.
Eligibility
Sex/Gender
All
Inclusion 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: o A history of seasonal allergic rhinoconjunctivitis (SAR) during the grass pollen season during at least the two previous years o A positive skin prick test (wheal diameter > 3 mm) to grass-pollen mixture o Specific IgE against grass pollen (RAST class 2 or IgE > 0.7 kU/l) o Asymptomatic to perennial inhalant allergens. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of this clinical trial in allergic patients is : • the assessment of the safety of gpASIT+TM. ;Secondary Objective: The secondary objectives of this trial are • the study of its impact on the immunological status of the subjects, • the study of the impact of gpASIT+TM on the clinical status of the subjects, • to determine if the efficacy of gpASIT+TM is dose related. ;Primary end point(s): The primary objective of the trial is to demonstrate clinical tolerability and safety of gpASIT+TM: the possible adverse reactions will be investigated via recording of • general physical status, vital signs (heart rate and blood pressure), • haematological parameters (hemoglobin, hematocrit, RBC, WBC including differential counts and platelets), • general blood biochemistry parameters, • all adverse events, serious adverse events, • immunological analysis (total IgE and IgG levels, anti-nuclear antibodies (ANA) and Rheumatoid Factor (RF)), • inflammatory parameters (C-Reactive protein (CRP), blood sedimentation rate). | — |
Countries
Belgium
Outcome results
None listed