Allergic rhinoconjunctivitis caused by grass pollen MedDRA version: 9.1 Level: LLT Classification code 10039085 Term: Rhinitis allergic
Conditions
Interventions
Trade Name: GRAZAX 75000 SQ-T lofilizzato orale estratti di allergene standardizzati di polline di Graminacee (Phleum Pratense 75000 SQ-T)
Pharmaceutical Form: Oral lyophilisate
Concentration unit: µ
Sponsors
ALK-ABELLO
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Male and Female, aged between 18 and 65 years Moderate/severe intermittent rhinoconjunctivitis or mild-moderate persistent rhinoconjunctivitis according to ARIA diagnostic criteria Positive Skin Prick Test wheal diameter larger than 3mm to grass pollen allergen Phleum pratense No clinically relevant pathologies In case of child bearing potential women, a negative pregnancy Test is required at enrollment and tha subject must use an appropriate contraceptive methods for the whole duration of the trial Written Informed Consent 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: Signs and Symptoms of acute infection to upper respiratory tract and /or acute otitis, and/or acute sinusitis at enrollment Admission in Emergency ward for ashtma attack during 12 months defore Visit 1 Past specific immunotherapy for allergens other than grass pollen during the past 2 years Past anaphylactic reactions food allergy, insect bites, drug allergy, anaphylaxis induced by exertion and/or angioedema Subject treated with immunosuppressive drugs Hypersensibility to tablets excipients
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate if treatment compliance to Grazax in adult subjects affected by allergic rhinoconjunctivitis caused by grass pollen can be improved giving an electronic device Memozax to patients from the beginning of the trial or 6 months after starting treatment;Secondary Objective: To evaluate tolerability and safety of Grazax To evaluate tolerability and safety of Grazax at the first dose To evaluate impact on quality of life, on rhinitis symptomathology score, after one year treatment with Grazax, compared to the previous pollen season.;Primary end point(s): The effect on treatment compliance related to the use of device that allows to check therapy adherence | — |
Countries
Italy
Outcome results
None listed