Grass Pollen Related Allergic Rhinoconjunctivitis MedDRA version: 7.0 Level: PT Classification code 10010744
Conditions
Interventions
Product Name: Tablets of 5-grasses allergen extract
Product Code: SLIT
Pharmaceutical Form: Tablet
INN or Proposed INN: Five grasses pollen allergen extract
Other descriptive name: cocksfoot, meadow g
Sponsors
Stallergenes S.A
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Male or female outpatients, aged 18-46 years (inclusive) 2. Grass pollen-related allergic rhinoconjunctivitis for at least the last two pollen seasons. 3. Sensitised to grass pollen (positive SPT and IgE level of at least Class 2) 4. Total symptom score on the RRTSS during the pollen season prior to the start of the V034.04 study of greater than or equal to 12. 5. Patients who are willing to comply with the protocol. 6. Patients must be in general good health as determined by past medical history, physical examination and safety laboratory tests. 7. 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. 8. Patients must have been compliant with respect to the completion of the daily record card and taking of the investigational product during study V034.04. 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 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 child-bearing 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 inhaled or systemic corticoid treatment may be included. 4. Patients who have taken oral steroids 4 weeks prior to enrolment in this study. 5. Patients who have received desensitisation treatment for grass pollen (other than study V034.04). 6. Patients at risk of non-compliance. 7. Participation in any other clinical study since end of V034.04. 8. Patients with a new or current disease, which as judged by the investigator, may affect the patient’s participation in or the outcome of the study. These diseases include, but are not limited to, cardiovascular disease, malignanacy, hepatic disease, renal disease, haematological disease, neurological disease, immunological disease and endocrine disease. 9. Patients treated with beta-blockers since end of V034.04.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Main objective : To assess the long-term treatment efficacy and efficacy maintenance (carry-over effect) 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: Secondary objectives : To assess the long-term treatment efficacy and efficacy maintenance (carry-over effect) of SLIT on the: rescue medication usage (use of anti-histamine: nasal cortico-steroids and systemic oral cortico-steroids); six individual symptom scores of the rhinoconjunctivitis symptom score (RSS); proportion of symptom-free days; global evaluation by the patient. To continue documentation of the safety of the treatment. ;Primary end point(s): The average RTSS during the third pollen period is the primary efficacy endpoint for long-term treatment efficacy, and the average RTSS during the fourth pollen period is the endpoint for the assessment of the maintenance of efficacy (carry-over effect). The start date of each pollen period is defined as the first day with grass pollen count of at least 30/ m cubed of air at a center, and the end date is the last day with grass pollen count of at least 30/ m cubed of air. | — |
Countries
Czech Republic, Denmark, Germany, Italy, Spain
Outcome results
None listed