allergic rhinoconjunctivitis induced by grass pollen MedDRA version: 14.1 Level: LLT Classification code 10001728 Term: Allergic rhinoconjunctivitis System Organ Class: 10015919 - Eye disorders
Conditions
Interventions
Product Name: Allergovac depot 0.25 SPT
Pharmaceutical Form: Suspension for injection
INN or Proposed INN: Phleum pratense polen extract
Current Sponsor code: N/A
Other descriptive name: Phleum praten
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 allergic rhinoconjunctivitis against Phleum pratense during a minimum of 2 years prior to study participation. Although allergic rhinoconjunctivitis is the pathology under study, the inclusion of patients with slight or moderate concomitant asthma is allowed 4. Patients who obtained a prick test result > or = to 3 mm diameter for Phleum pratense 5. Patients with a value of specific IgE > or = to class 2 (CAP/PHADIA) Phleum pratense. Positive and negative control of the test should give consistent results. 6. Patients will preferably be monosensitized to Phleum pratense with clinically relevant symptoms to Phleum pratense. In the case of polysensitized patients they can only be included if other sensitizations are caused by: a) Overlapping and cross-reactive pollen (referring to Phleum pratense) b) Not overlapping pollen (referring to Phleum pratense) and that are not supposed to cause symptoms during the study period c) other allergens that are not supposed to cause symptoms during the study period 7. Women of childbearing potential must have a negative urine pregnancy test at Screening visit/Visit 0 8. Women of childbearing potential must agree to use an appropriate contraception method during the study if they are sexually active, if they have not been surgically sterilized or present any other incapacity to bear children. 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 150 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Stable and continued use of medication for allergic pathology during 2 weeks prior to inclusion. 2. Patients sensitized to other overlapping seasonal and not cross-reactive to Phleum pratense allergens, and with specific IgE levels higher or equal to class 2 CAP/PHADIA. 3. Patients who received immunotherapy in the previous 5 years for Phleum pratense or for any allergen with cross reactivity or patients that are currently receiving immunotherapy for any allergen. 4. Patients with severe asthma or FEV1< 70% or asthma requiring inhaled or systemic corticoid treatment at entry or within 8 weeks prior to treatment commencement. 5. Patients with immunological, cardiac, renal or hepatic illnesses or any other medical condition that in the investigator’s judgment may interfere with the study evaluation or affect subject safety 6. Patients with a previous history of anaphylaxis 7. Patients with chronic urticaria 8. Patients with moderate-sever atopic dermatitis 9. Patients with clinically relevant malformations of the upper respiratory tract 10. Patients who have participated in another clinical trial within 3 month prior to enrolment. 11. Female patients who are pregnant or breast-feeding. 12. Patients under treatment with tricyclical antidepressives, psychotropes (psychodrugs) beta-blockers, or Angiotensin Converting Enzyme Inhibitors (ACEI) 13. Patient who does not attend the visits 14. Patient’s lack of collaboration or refusal to participate
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To compare the efficacy of 5 different doses of subcutaneous immunotherapy in Depot presentation in patients with allergic rhinoconjunctivitis with or without asthma sensitized to Phleum pratense.;Secondary Objective: Safety;Primary end point(s): The principal endpoint is the variation on the concentration of Phleum pratense extract needed to produce a positive nasal provocation test from baseline (V0) to final visit (VF). The changes will be compared between groups (including the placebo).;Timepoint(s) of evaluation of this end point: 18 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Efficacy and Safety;Timepoint(s) of evaluation of this end point: 18 weeks | — |
Countries
Portugal, Spain
Contacts
Public ContactUPM Madrid
Nuvisan Clinical Development Solutions Spain, S.L.U.
Outcome results
None listed