Phase I, open, multicenter study, with subcutaneous immunotherapy in depot presentation, in patients with rhinoconjunctivitis sensitized to Olea europaea.

BIAL Industrial Farmaceutica S.A.0 个研究点目标入组 49 人开始时间: 2014年11月3日最近更新: 2018年7月23日

适应症

试验速览

暂无简介。

•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

•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
•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
•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.

发起方

BIAL Industrial Farmaceutica S.A.