EUCTR2011-000814-21-PT进行中（未招募）不适用
A phase II, multicentre, randomized, double-blind study with subcutaneous immunotherapy at different doses, in parallel groups and placebo controlled in patients with rhinoconjunctivitis ± asthma sensitized to Phleum pratense.
BIAL INDUSTRIAL FARMACEUTICA, S.A.0 个研究点目标入组 150 人开始时间: 2011年6月28日最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 150
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •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
排除标准
- •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
研究者
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