Rhinoconjunctivitis MedDRA version: 19.1 Level: LLT Classification code 10039097 Term: Rhinoconjunctivitis System Organ Class: 100000004862
Conditions
Interventions
Product Name: Allergovac depot Olea
Product Code: V01AA
Pharmaceutical Form: Suspension for injection
INN or Proposed INN: Olea europaea extract
Other descriptive name: ALLERGENS, POLLEN & PLANT EXTRA
Sponsors
BIAL Industrial Farmaceutica S.A.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Patients must sign the informed consent form. 2. Patients must be between 18 and 60 years of age. 3. Patients with seasonal rhinoconjunctivitis against Olea europaea during a minimum of 2 years prior to study participation. Although allergic rhinoconjunctivitis is the pathology under study, the inclusion of patients with mild concomitant asthma is allowed. 4. Patients who obtained a prick test result over 3 mm diameter to Olea europaea. Positive and negative control of the test should give consistent results. 5. Patients with a value of specific IgE equel or superior to class 2 (CAP/PHADIA) to Olea europaea. 6. Patients will sensitized to Olea europaea with clinically relevant symptomatology to its exposal. 7. Patients who comply with all treatment windows as described per protocol for both study treatment and procedures. 8. Women with menarche must have a negative urine pregnancy test prior to their enrolment in the study, as well as agree to use an appropriate contraception method during the study if they are sexually active. 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 49 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Patients who received immunotherapy in the previous 5 years for Olea europaea or for any allergen with cross reactivity or patients that are currently receiving immunotherapy for any allergen. 2. Patients with severe asthma or FEV1< 70%, although it is controlled with medication. 3. Patients with immunological, cardiac, renal or hepatic illnesses or any other medical condition that the investigator deems relevant so as to interfere with the study. 4. Patients with a previous history of anaphylaxis 5. Patients with chronic urticaria. 6. Patients with moderate to severe atopic dermatitis 7. Patients who have participated in another clinical trial within 3 month prior to enrolment. 9. Female patients who are pregnant or breast-feeding 10. Patients under treatment with tricyclical antidepressives, phenotiazines, -blockers, or Angiotensin Converting Enzyme Inhibitors (ACEI) 11. Patient who does not attend the visits 12. Patient?s lack of collaboration or refusal to participate.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: - To assess safety and tolerability of subcutaneous inmunotherapy in depot presentation and fast dosage , in patients suffering from rhinoconjunctivitis sensitized to Olea europaea, with ages between 18 and 60 years old.;Secondary Objective: - To assess the safety related to depot presentation regarding inmunoglobuline levels. - To describe the adverse reactions occured during the process of drug administration .;Primary end point(s): - The incidence of adverse reactions in reference to the number of patients and number of immunotherapy administrations received by each of them in the study. To do this, it will take place a description of the number of adverse events, adverse reactions and division between local and systemic, along with the gradation of the latter, taking into account the standards described in (Alvarez-Cuesta et al, 2006). The procedure for collecting adverse reactions is detailed in section 9.3.5. Moreover, there will be recorded the analytical parameters outside normal range and considered by the investigator as relevant under his own judgment, to be considered as adverse events.;Timepoint(s) of evaluation of this end point: From Screening Visit (V0) to Final study Visit (VF). | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Effectiveness - Comparison of the differences obtained in the inmunoglobuline levels: specific IgE, specific IgG and specific IgG4 between V0 and VF. - Skin tests (prick test dose response): comparison of the differences obtained in the wheal size. - Skin tests (prick test dose response): comparison of the differences obtained in the wheal size between V0 and VF. - Differences in the results of the dose-response relation prick test wheal size obtained in VF. Safety - Detailed as primary endopoint.;Timepoint(s) of evaluation of this end point: From Screening Visit (V0) to Final study Visit (VF). | — |
Countries
Spain
Contacts
Public ContactDynamic S.L.
Dynamic S.L.
Outcome results
None listed