EUCTR2004-001538-18-SE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/A
ETI Pharma GmbH0 个研究点目标入组 70 人开始时间: 2004年8月5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
- 70
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
- •- Patients of both gender at an age from 6 up to 45 years
- •- Prior to study specific examinations, the patient has to give his/her written informed consent. If patients under legal age will be included, the informed consent must be signed by at least one of the parents or the legal responsible guardian.
- •- The patients have to suffer from seasonal complaints (rhinitis and/or rhinoconjunctivitis with or without allergic asthma) caused by clinical sensitisation
- •against birch pollen. The sensitisation against birch pollen has to be verified by
- •- suggestive medical history
- •- a positive skin prick test for birch pollen, resulting in a wheal diameter of at
- •least 4 mm > negative control reaction or '++' versus histamine
- •- specific IgE for birch pollen >= 2
- •- Patient’s perception of disease activity of at least 30 mm on a 100 mm visual analogue scale (VAS)
- •Are the trial subjects under 18? yes
- •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
- •- pregnant or lactating women
- •- women of child-bearing age not employing sufficient contraceptive protection
- •- 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 4 mm > negative control reac-tion 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
- •- participation in an immunotherapy with comparable extracts within the last five years
- •- participation in another clinical trial within the last 3 month prior to this study
- •- any contra-indication for the unspecific bronchial challenge test
- •- smokers with a manifested bronchopathy
- •- alcohol- or drug abusers
- •- persons, who are obviously not compliant
- •- patients with other known concomitant diseases:
- •- acute tuberculosis
- •- inflammatory or infectious diseases of the target organs effective
- •- advanced secondary changes at the target organ (e.g. emphysema or bronchiectasis)
- •- immunopathological diseases (e.g. of the liver, kidney, the nervous system, thyroid gland, rheumatic diseases) in which autoimmune mechanisms play a role
- •- immune deficiencies
- •- history of status asthmaticus, heart- and vascular insufficiency, treatment with beta-blockers
- •- any disease which prohibits the use of adrenaline (e. g. hyperthyroidism)
- •- serious psychiatric / psychological disturbances
- •- concomitant treatment with substances interfering with the immune system
研究者
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