EUCTR2006-003067-31-LT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8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
- 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
- •1.Pregnant or lactating women
- •2.Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, including women whose career, lifestyle, or sexual
- •orientation precludes intercourse with a male partner and women whose
- •partners have been sterilized by vasectomy or other means, unless they meet
- •the following definition of postmenopausal: 12 months of natural (spontaneous)
- •amenorrhea or 6 months of spontaneous amenorrhea with serum FSH levels >
- •40 mIU/mL or are using one or more of the following acceptable methods of
- •contraception:
- •a) surgical sterilization (e.g., bilateral tubal ligation, hysterectomy)
- •b) hormonal contraception (implantable, patch, oral)
- •c) double-barrier methods (any double combination of: IUD, male or female
- •condom with spermicidal gel, diaphragm, sponge, cervical cap)
- •Acceptable methods of contraception may include total abstinence at the
- •discretion of the investigator in cases where the age, career, lifestyle, or sexual
- •orientation of the patient ensures compliance. Periodic abstinence (e.g.,
- •calendar, ovulation, symptothermal, postovulation methods) and withdrawal are
- •not acceptable methods of contraception. Reliable contraception should be
- •maintained throughout the study and for 30 days after study drug
- •discontinuation.
- •3.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
- •4.Participation in an immunotherapy with comparable extracts within the last five years
- •5.Participation in another clinical trial within the last 3 months prior to this study
- •6.Smokers with a manifested bronchopathy
- •7.Alcohol or drug abusers
- •8.Persons, who are obviously not compliant
- •9.Patients, who are employees at the investigational site, relative or spouse of the investigator
- •Patients with other known concomitant diseases:
- •10.Acute tuberculosis
- •11.Acute and chronic inflammatory or infectious diseases (incl. target organ)
- •12. Advanced secondary changes at the target organ (e.g. emphysema or bronchiectasis)
- •13.Immunopathological diseases (e.g. of the liver, kidney, the nervous system, thyroid gland, rheumatic diseases) in which autoimmune mechanisms play a role
- •14.Immune deficiencies
- •15.Uncontrolled asthma, defined as FEV1 or PEF = 70% of predicted normal value
- •16.Treatment with b-blockers
- •17.Malignancies during the last 5 years
- •18.Any disease which prohibits the use of adrenaline (e.g. hyperthyroidism)
- •19.Serious psychiatric/psychological disturbances
- •20.Concomitant treatment with substances interfering with the immune system
研究者
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