Grass Pollen Rhinoconjunctivitis MedDRA version: 8.1 Level: LLT Classification code 10039085 Term: Rhinitis allergic
Conditions
Sponsors
Stallergenes S.A.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Male or female patients aged 5 to 17 years (inclusive); outpatients. 2. Written consent / assent (as applicable). 3. Grass pollen-related allergic rhinoconjunctivitis for the last two pollen seasons. 4. Sensitised to grass pollen (positive skin prick test and grass pollen-specific IgE level of at least Class 2). 5. Total symptom score on the RRTSS during the previous pollen season of greater than or equal to 12. Are the trial subjects under 18? yes Number of subjects for this age range: F.1.2 Adults (18-64 years) no 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: • Patients with symptoms of rhinoconjunctivitis during the grass pollen season due to sensitisation to allergens other than grass pollen must not be included. Patients must be asymptomatic to all other allergens during the grass pollen season. Patients who have allergic rhinitis due to perennial allergen may not be included. • Asthma requiring treatment other than beta-2 inhaled agonists. • Patients who have received any desensitisation treatment for grass pollen. • Treatment by immunotherapy with any other allergen within the previous 5 years or ongoing.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the safety and efficacy of SLIT compared with placebo for reduction of symptoms and rescue medication usage. To assess the efficacy of SLIT on the: - Rhinoconjunctivitis Total Symptom Score (RTSS) of the six rhinoconjunctivitis symptoms sneezing, rhinorrhoea, nasal pruritus, nasal congestion, ocular pruritus and watery eyes.;Secondary Objective: To assess the efficacy of SLIT on the: - Rescue medication usage (use of antihistamine, nasal topical treatment and systemic corticosteroids). - Combined Score - a score taking into account the RTSS and rescue medication usage. - Six individual symptom scores of the Rhinoconjunctivitis Symptom Score (RSS). - Proportion of symptom-free days. - Global evaluation of the efficacy of SLIT by the patient. To document the safety of the treatment.;Primary end point(s): The average RTSS (Rhinoconjunctivitis Total Symptom Score) while on treatment is the primary efficacy endpoint. | — |
Countries
France, Germany
Outcome results
None listed