PATIENTS WITH RHINOCONJUNCTIVITIS SENSITISED TO PARIETARIA JUDAICA
Conditions
Interventions
Trade Name: Allergovac depot
Product Name: Allergovac depot
Pharmaceutical Form: Suspension for injection
Sponsors
Bial Industrial Farmacéutica S.A.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Signed informed consent 2. Aged between 18 and 60 3. Patients with seasonal allergic rhinoconjunctivitis caused by Parietaria judaica for at least 2 years before participating in the study. Allergic rhinoconjunctivitis is the main pathology under study but patients with concomitant mild asthma may also be included. 4. Prick test results > 3 mm against Parietaria judaica. The positive and negative control tests should give consistent results. 5. Patients with allergen specific IgE value = class 2 (CAP / PHADIA) against Parietaria judaica. 6. Patients sensitized to Parietaria judaica with clinically relevant symptoms and, according to medical criteria, 100% eligible for the type of immunotherapy used in this trial. 7. Women of childbearing potential must provide a negative pregnancy test and agree to use adequate contraception 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 52 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 have received prior immunotherapy anytime during the 5 years prior to the tested for the allergen under study or allergens with cross- reactivity, as well as patients currently receiving any allergen specific immunotherapy. 2. Patients with severe asthma or FEV1 <70 % or so with asthma requiring treatment with inhaled or systemic corticosteroids at the time of study entry or within 8 weeks of the start of treatment. 3. Patients with immune, heart, kidney or liver or any other disease with sufficient relevance to interfere with the study disease (as per medical criteria). 4. Patients with a history of anaphylaxis. 5. Patients with chronic urticaria. 6. Patients with moderate/severe atopic dermatitis 7. Patients with clinically relevant malformations of the upper respiratory tract. 8. Patients who have participated in another clinical trial three months ago . 9. Pregnant or breastfeeding women. 10. Patients treated with tricyclic antidepressants, phenothiazines, ß -blockers, and angiotensin converting enzyme inhibitors (ACEIs) . 11. Difficulty/Impossibility to attend the visits. 12.Lack of collaboration or refusal to participate in the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the safety and tolerability of subcutaneous immunotherapy in depot presentation and guideline fast in patients with rhinoconjunctivitis with or without asthma sensitized to Parietaria judaica, aged between 18 and 60 through the identification and classification of adverse reactions throughout the duration of the clinical trial;Secondary Objective: To evaluate the indirect efficacy of subcutaneous immunotherapy through of measurement of changes in the levels of specific IgE, total IgG and IgG4 and the realization of the dose-response prick test;Primary end point(s): The number, rate and severity of adverse reactions with reference to the number of patients and number of administrations received in the study;Timepoint(s) of evaluation of this end point: -throughout the study | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): -Difference in the immunoglobulins levels: specific IgE, total IgG and IgG4 in each group, between V0 and VF. -Difference in the immunoglobulins levels: specific IgE, total IgG and IgG4 obtained in VF comparing treatment versus placebo group. ;Timepoint(s) of evaluation of this end point: At the end of the clinical trial | — |
Countries
Spain
Contacts
Public ContactClinical Project Manager
Bial Industrial Farmacéutica S.A.
Outcome results
None listed