EUCTR2006-003067-31-DE进行中（未招募）不适用
A randomized, double blinded, placebo controlled multicenter study for the efficacy and safety of Depigoid® tree pollen
ETI Pharma GmbH0 个研究点目标入组 230 人开始时间: 2006年8月17日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 230
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 of both gender aged from 18 up to 65 years
- •2.Prior to study specific examinations the patient has to give his/her written informed consent
- •3.Patient’s perception of disease activity of at least 30 mm on a 100 mm visual analogue scale (VAS)
- •4.FEV1 or PEF > 70% of predicted normal value under normal conditions
- •5.The patients have to suffer from allergic complaints (rhinitis and/or rhinoconjunctivitis with or without allergic asthma) caused by clinical sensitization against tree pollen. The IgE mediated sensitization has to be verified by
- •·Suggestive medical history
- •·A positive skin prick test LETI for tree pollen, resulting in a wheal diameter of at least 3 mm > negative control reaction or '++' versus histamine
- •·Specific IgE >=1 (CAP-RAST)
- •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
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •6.Pregnant or lactating women
- •7.Women of child bearing age not employing sufficient contraceptive protection (contraceptive medication or condom)
- •8.Clinical relevant manifestation -defined as positive suggestive history within the last 12 months checked by a comprehensive questionnaire of symptoms, confirmed by a positive skin prick test (wheal diameter of at least 3 mm > negative control reaction or '++' versus histamine) as well as by specific IgE (RAST I or higher) -of the following allergies:
- •·A perennial allergy against house dust mites (Dermatophagoides pteronyssinus or D. farinae), animal epithelia (of cats or dogs) or mould
- •·A seasonal allergy against grasses (included rye) or weeds
- •9.Participation in an immunotherapy with comparable extracts within the last five years
- •10.Participation in another clinical trial within the last 3 months prior to this study
- •11.Smokers with a manifested bronchopathy
- •12.Alcohol or drug abusers
- •13.Persons, who are obviously not compliant
- •14.Patients, who are employees at the investigational site, relative or spouse of the investigator
- •Patients with other known concomitant diseases:
- •15.Acute tuberculosis
- •16.Acute and chronic inflammatory or infectious diseases (incl. target organ)
- •17.Advanced secondary changes at the target organ (e.g. emphysema or bronchiectasis)
- •18.Immunopathological diseases (e.g. of the liver, kidney, the nervous system, thyroid gland, rheumatic diseases) in which autoimmune mechanisms play a role
- •19.Immune deficiencies
- •20.Uncontrolled asthma, defined as FEV1 or PEF = 70% of predicted normal value
- •21.Treatment with b-blockers
- •22.Malignancies < 5 years
- •23.Any disease which prohibits the use of adrenaline (e.g. hyperthyroidism)
- •24.Serious psychiatric/psychological disturbances
- •25.Concomitant treatment with substances interfering with the immune system
研究者
相似试验
进行中（未招募）
不适用
A randomized, double blinded, placebo controlled multicenter study for the efficacy and safety of Depigoid® tree polleEUCTR2006-003067-31-LTETI Pharma GmbH230
进行中（未招募）
不适用
A randomized, double blinded, placebo controlled multicenter study for the efficacy and safety of Depigoid® House dust mites (HDM) in patients suf-fering from moderate to severe atopic eczema.Moderate to severe atopic eczema with or without rhinitis and/or rhinoconjunctivitis caused by clinical relevant IgE-mediated sensitization against House dust mites (HDM) leading to aggravation of patient’s skin lesions.MedDRA version: 8.1Level: LLTClassification code 10003641Term: Atopic eczemaEUCTR2006-003066-34-DEETI Pharma GmbH
进行中（未招募）
不适用
A randomised, double blinded, placebo controlled multicentre study for the efficacy and safety of Depigoid birch pollen - N/AEUCTR2004-001538-18-SEETI Pharma GmbH70
进行中（未招募）
1 期
A trial to test the effect of BL-8040 or placebo given to AML patients in addition to standard treatment in masked manner.consolidation therapy in acute myeloid leukemia in first complete remissionMedDRA version: 21.0Level: LLTClassification code 10000886Term: Acute myeloid leukemiaSystem Organ Class: 100000004864EUCTR2014-002702-21-DEMartin-Luther-Universität Halle- Wittenberg194
已完成
2 期
Effects of perioperative Recombinant Human Erythropoietin administration on proinflammatory cascade following breast cancer surgery.Female subjects with breast cancer stage II/III undergoing a modified radical mastectomyCancer - BreastInflammatory and Immune System - Other inflammatory or immune system disordersACTRN12610000813088niversity Hospital of Ioannina22