OPEN CLINICAL TRIAL, MULTICENTER, WITH SUBCUTANEOUS IMMUNOTHERAPY IN DEPOT PRESENTATION, IN PATIENTS WITH ALLERGY RHINOCONJUNCTIVITIS SENSITIZED TO PARIETARIA JUDAICA - BIA-PAR-DEPOT

Bial Industrial Farmacéutica S.A.0 个研究点目标入组 52 人开始时间: 2014年11月11日最近更新: 2018年9月3日

研究概览

暂无简介。

•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

•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.

发起方

Bial Industrial Farmacéutica S.A.