EUCTR2008-006292-77-DE进行中（未招募）不适用
SUBLIVAC® Birch PROBE study
HAL Allergy0 个研究点开始时间: 2009年2月12日最近更新:
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
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
- •Subjects with allergic rhinoconjunctivitis with or without mild asthma (FEV1 = 70%) due to birch pollen for at least 2 years.
- •Use of anti-allergy symptomatic medication in the last birch pollen season (in case of a season with low pollen counts, in one of the two previous years).
- •No seasonal allergic complaints induced by birch, grasses or mugwort pollen for at least 4 weeks in the absence of rescue medication during at least the last 2 weeks before the baseline.
- •A positive SPT (diameter =3 mm) for birch pollen and a positive specific serum anti birch IgE-test (>1 U/ml).
- •A positive TNPT with a birch allergen extract containing a concentration of 10, 100 or 1000 AU/ml at the baseline visit.
- •Age 18 years and older.
- •Subjects shall give a written informed consent.
- •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) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •A positive SPT (diameter = 3mm) for hazel or alder and the maintenance dose will not be reached before 8 October 2009.
- •A positive SPT (diameter = 3mm) for pets and symptoms related to concomitant sensitization to pets while having these animals at home.
- •A positive SPT (diameter = 3mm) for house dust mite or moulds and clinically relevant symptoms related to concomitant sensitization to house dust mite or moulds, based on the investigator's research (TNPT for example).
- •Allergy to any of the excipients of SUBLIVAC Birch or Staloral Birch.
- •Chronic asthma or emphysema, particularly with an FEV1 < 70 % of predicted value or use of inhalation corticosteroids outside grass and tree pollen season for more than two episodes and/or longer than fourteen days.
- •Specific findings for nose and mouth at screening or rhinoscopy before TNPT.
- •Serious immuno-pathological diseases or malignancies (including auto-immune diseases, tuberculosis, HIV).
- •Inflammation or infection of the target organ (nose, eyes and lungs).
- •Severe atopic dermatitis requiring systemic immuno-suppressive medication.
- •Allergen specific immunotherapy treatment for a period longer than three months within the last 5 years.
- •History of life threatening anaphylactic events, including anaphylactic food allergy, insect venom anaphylaxis, exercise or drug induced anaphylaxis.
- •A positive pregnancy test, lactation or inadequate contraceptive measures. (adequate measures: oral contraceptives, IUD, condom use and having no sexual
- •relationship with a man)
- •Alcohol- or drug abuse.
- •Lack of co-operation or severe psychological disorders.
- •Completed or ongoing long-term treatment with tranquilizer or psycho active drugs.
- •Low compliance or inability to understand instructions/study documents
- •Completed or ongoing treatment with anti-IgE-antibody
- •Patients being in any relationship or dependence with the sponsor or investigator
研究者
相似试验
进行中（未招募）
1 期
Twin SUBLIVAC® Grasses Clinical Efficay StudyIgE mediated allergic disorders triggered by grass pollenEUCTR2005-005175-16-BEHAL Allergy BV
进行中（未招募）
不适用
Twin SUBLIVAC® Grasses Clinical Efficay StudyEUCTR2005-005175-16-NLHAL Allergy BV210
进行中（未招募）
不适用
Twin SUBLIVAC® Grasses Clinical Efficay StudyIgE mediated allergic disorders triggered by grass pollenEUCTR2005-005175-16-DEHAL Allergy BV210
已完成
3 期
Twin SUBLIVAC® Grasses Clinical Efficay StudyhayfeverIgE mediated allergic disorders triggered by grass pollen10003816NL-OMON30665HAL Allergenen Lab25
进行中（未招募）
不适用
A Pilot study investigating the use of Intravitreal Triamcinolone prior to macular laser for Clinically Significant Diabetic Macular Oedema - CSMO and triamcinoloneMacular oedema affects 29% of diabetic patients and is the main cause of visual impairment. Previous studies show that diffuse macular oedema carries a particularly poor prognosis despite laser photocoagulation.EUCTR2004-005043-97-GBSt Mary's NHS Trust50