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: Sublingual tablet
INN or Proposed INN: Five grasses pollen allergen extract
Other descriptive name: Cocksfoo
Sponsors
Stallergenes S.A.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: The inclusion criteria are to be verified at Screening (Visit 1) and reviewed at Visit 2. Patients must meet all of the following inclusion criteria in order to participate in this study: 1.Male or female outpatients, aged 5 to 17 years (inclusive). 2. Patients with grass pollen-related allergic rhinoconjunctivitis for at least the last two pollen seasons. 3. Patients / parents / legal guardians who have been informed of the nature and aims of the study and have given their written consent / assent (as applicable) at Visit 1 to participate in this study in accordance with local laws and requirements 4. Patients / parents / legal guardians who are willing to comply with the protocol. 5. Patients must be in general good health as determined by past medical history, physical examination and safety laboratory tests. 6. Female patients of childbearing potential are eligible if they are not sexually active or if they use a medically accepted contraceptive method (hormonal birth control [orally, injectable or by implant, for at least 2 months before enrolment], intrauterine device, spermicide used with male condom, bilateral tubal ligation, diaphragm with spermicide, female condom, monogamous relationship with vasectomised partner). Note: Female patients are considered not to have childbearing potential before their menarche, or if they have had a total hysterectomy, bilateral oophorectomy or ovariectomy. 7. Negative urine pregnancy test on all females who have had their menarche. 8. Patients / parents / legal guardians 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. 9. Positive SPT (wheal diameter greater than 3 mm) and IgE values greater than or equal to Class 2 for grass pollen allergens. 10. 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? 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: The exclusion criteria are to be verified at Screening and reviewed at Visit 2. Patients must not meet any of the following exclusion criteria in order to participate in this study: 1. Allergic rhinoconjunctivitis due to a co-sensitisation 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 inhaled or systemic corticoid treatment may be included. 4. Patients who have taken oral steroids within 4 weeks of the Screening (Visit 1). 5. Patients who have received any desensitisation treatment for grass pollen. 6. Treatment by immunotherapy with any other allergen within the previous 5 years. 7. Patients at risk of non-compliance. 8. Participation in any clinical study during the previous 3 months. 9. Children of investigators, co-investigators, and of all the study collaborators should not be enrolled in the study. 10. 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. 11. Patients treated with beta-blockers or under continuous corticotherapy. 12. Usual contraindications of immunotherapy such as serious immunopathologic conditions or malignancies. 13. Patients with a history of drug or alcohol abuse. 15. Patients with fever, flu or an upper respiratory tract infection must be treated appropriately. They can be randomised after resolution of the episode.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess the efficacy of SLIT on the: • Rhinoconjunctivitis Total Symptom Score of the six rhinoconjunctivitis symptoms sneezing, rhinorrhea, 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 [oral and eye drops], nasal corticosteroids and systemic corticosteroids). - Six individual symptom scores of the RSS. - Proportion of symptom-free days. - Global evaluation of the efficacy of SLIT by the patient. • To document the safety of the treatment. Exploratory Objectives • To assess the efficacy of SLIT on the: - Combined Score – a score taking into account the RTSS and rescue medication usage. - Immunological markers (IgE and IgG4) specific for grass pollen allergens. - Asthma. ;Primary end point(s): The average Retrospective Rhinoconjunctivitis Total Symptom Score (RRTSS) during the pollen period while the patient is still taking the investigational product is the primary efficacy endpoint for this study. The start date of the pollen period is defined as the first day with a grass pollen count above a pre-defined cut-off value (30 grass pollen particles per m3 of air) and the end date as the last day with a pollen count above the pre-defined cut-off value. The pollen period will be centre specific. | — |
Countries
Denmark, Estonia, Germany, Latvia
Outcome results
None listed