Grass Pollen Related Allergic Rhinoconjunctivitis MedDRA version: 7.0 Level: PT Classification code 10010744
Conditions
Interventions
Product Name: Tablets of 5-grasses allergen extract
Pharmaceutical Form: Tablet
INN or Proposed INN: Five-grass pollen allergen extract
Other descriptive name: cocksfoot, meadow grass, rye grass, swee
Sponsors
Stallergenes S.A.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Male or female outpatients, aged 18 to 45 years (inclusive). 2. Patients with documented grass pollen-related allergic rhinoconjunctivitis for at least 2 years (last 2 pollen seasons). 3. Patients who have been informed of the nature and aims of the study and have given their written consent / assent to participate in this study in accordance with local laws and requirements (refer to Appendix 3). 4. Patients who are able to understand the information given and the text of the consent form, and who are able to complete the daily record card and the RQLQ. 5. Positive SPT (wheal diameter greater than 3 mm) and positive RAST (greater than or equal to Class 2) for grass pollen. 6. A score of greater than or equal to 12 on the RRTSS. (Evaluation of the most severe symptoms during the previous pollen season). 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: 1. Allergic rhinoconjunctivitis due to a cosensitisation likely to significantly change the symptoms of the patient throughout the study or patients who have symptoms of rhinoconjunctivitis during the Treatment Phase due to sensitisation to allergens other than the grass pollens. 2. Pregnancy, breast-feeding / lactation or sexually active women of childbearing potential who are not using a medically accepted contraceptive method. 3. Asthma requiring treatment other than beta-2 inhaled agonists. Patients with intermittent asthma not necessitating nasal or systemic corticoid treatment may be included. 4. Patients who have received desensitisation treatment for grass pollen. 5. Patients with a past or current disease, which as judged by the investigator, may affect the patient’s participation in or the outcome of this study. These diseases include, but are not limited to, cardiovascular disease, malignancy, hepatic disease, renal disease, haematological disease, neurological disease, immunological disease and endocrine disease. 6. Patients treated with beta-blockers or under continuous corticotherapy. 7. Treatment by immunotherapy with another allergen within the previous 5 years.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess the efficacy of SLIT on the: Rhinoconjunctivitis Total Symptom Score (RTSS) of the six rhinoconjunctivitis symptoms sneezing, rhinorrhea, nasal pruritis, nasal congestion, ocular pruritis and watery eyes. ;Secondary Objective: To assess the efficacy of SLIT on the: Rescue medication usage (use of antihistamine, nasal corticosteroids and systemic corticosteroids). Six individual symptom scores of the Rhinoconjunctivitis Symptom Score (RSS). Overall Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) score. Global evaluation by the patient. To document the safety of the treatment. ;Primary end point(s): Rhinoconjunctivitis Total Symptom Score | — |
Countries
Czech Republic, Denmark, Germany, Hungary, Italy, Spain
Outcome results
None listed