EUCTR2008-002264-34-LT进行中（未招募）不适用
Randomised, double blinded, placebo controlled, parallel group study toevaluate efficacy and safety of Depigoid® Grass / Birch Mix in patients withallergic rhinitis and/or rhinoconjunctivitis with or without mild intermittentasthma.
ETI Pharma GmbH0 个研究点目标入组 210 人开始时间: 2008年7月3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
- 210
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. Prior to study specific examinations the patient and if applicable both legal
- •guardians has to give his/her written informed consent
- •2. Patients of both gender aged from 12 and 70 years
- •3. Patient`s perception of disease activity of at least 30 mm on a 100 mm visual
- •analogue scale (VAS)
- •4. FEV1 of PEF = 80% of predicted normal value under normal conditions
- •5. Patients have to suffer from allergic complaints (rhinitis and/or rhinoconjunctivitis with or without mild intermittent allergic asthma) caused by clinical sensitization against grass AND birch pollen. The IgE mediated sensitization has to be verified by:
- •- Suggestive medical history
- •- specific IgE against grass AND birch pollen CAP RAST =2
- •- a positive skin prick test (SPT) or nasal provocation test for grass pollen AND
- •birch pollen (SPT resulting in a wheal diameter of at least 3 mm > negative
- •control reaction or ‘++’ versus histamine; the nasal provocation test is deemed to
- •be negative, if no reaction emerges in consequence to an application of a
- •maximum concentration of 1/10 or the best results may be up to 1 year old). If both tests are performed,
- •the result of the NPT will be decisive.
- •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
- •Disease specific criteria
- •1. History of significant clinical manifestations of allergy as a result of sensitization
- •against weed pollen allergens and perennial (e.g. house dust mite)
- •For clarification: According to the decision tree (see Appendix 3) patients with typical symptoms against the co-allergens, weed pollen, house dust mite, cat and dog, mould are
- •not allowed to enter the trial. Patients without symptoms will enter the trial if they are not exposed to the allergen even if CAP RAST is = 2. In case they are exposed to the allergen they must have a specific CAP RAST < 2 to be able to enter the trial.
- •2. Persistent asthma (GINA = II)
- •Patients with other known concomitant diseases / treatments
- •3. Active tuberculosis
- •4. Acute and chronic inflammatory or infectious diseases at the target organ
- •5. Advanced secondary changes at the target organ (e.g. emphysema or bronchiectasis)
- •6. Immunopathological diseases (e.g. of the liver, kidney, the nervous system,
- •thyroid gland, rheumatic diseases)
- •7. Immune deficiencies
- •8. Uncontrolled asthma, defined as FEV1 or PEF = 80% of predicted normal value
- •9. Any disease which prohibits the use of adrenaline (e.g. hyperthyroidism)
- •10. Cardiovascular insufficiency or any severe or unstable pulmonary, or endocrine
- •disease; clinically significant renal or hepatic disease or dysfunction; hematologic disorder; any other clinically significant medical condition that could increase the risk to the study participant
- •11. Malignant disease of any kind during the previous 5 years
- •12. Abnormal laboratory parameters and vital signs that could increase the risk to
- •the study participant
- •13. Alcohol, drug or medication abuse within the past year
- •14. Severe psychiatric / psychological / neurologic disorders
- •Patients with other known previous / concomitant treatments
- •The following therapies are not allowed within the specified period prior to
- •screening as well as during the study and will prevent the patient from being
- •included into the study:
- •15. Participation in an immunotherapy against grass and/or birch pollen with
- •comparable extracts within the last five years
- •16. Locally and systemically treatment with ß-blocker is not allowed during the
- •entire study and will lead to the patient being withdrawn
- •17. Treatment with substances interfering with the immune system are not allowed
- •during the entire study and will lead to the patient being withdrawn
- •18. Treatment with tranquilizer or psychoactive drugs
- •19. Treatment with systemic corticosteroids within 3 months prior to the study
- •20. An immunization with vaccines 7 days prior and 14 days post an injection
- •21. Patients who are expected to be non-compliant and/or not co-operative
- •22. Participation in any other clinical study within the last 30 days prior to the
- •start of the study
- •23. Patients who have already participated in this study
- •24. Patients who are employees at the investigational site, relatives or spouses
- •of the investigator
- •25. Any donation of germ cells, blood, organs, or bone marrow during the course
- •of the study
- •26. Patients who are not contractually capable Special restrictions for female patients
- •27. Pregnant or nursing (lactating) women, where pregnancy is defined as the
- •state of a female after conception and until the termination of gestation
- •28. 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 part
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