EUCTR2008-008448-26-DE进行中（未招募）不适用
Randomized, double-blind, parallel group, multicenter study to evaluate theefficacy and safety of four doses of depigmented glutaraldehyde polymerized birch pollen allergenic extract (Depigoid® Birch) in patients with allergic rhinitis and/or rhinoconjunctivitis with or without intermittent asthma
ETI Pharma GmbH0 个研究点目标入组 320 人开始时间: 2009年6月10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
- 320
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 will be eligible for inclusion into the study only if all of the following criteria
- •1. Patients have provided an appropriately signed and dated informed consent prior to
- •any study specific examination,
- •2. Patients must be = 18 and = 70 years of age at Visit 1,
- •3. Patients must have a perception of disease activity of at least 30 mm on a 100 mm
- •visual analogue scale (VAS),
- •4. Patients must have an FEV1 or PEF value > 80% of the predicted normal value (for PEF: highest result of 3 measurements),
- •5. Patients must complain about allergic rhinitis and/or rhinoconjunctivitis symptoms for
- •at least 2 years with or without intermittent asthma symptoms, caused by clinical sensitization against birch pollen,
- •6. IgE-mediated sensitization has to be verified by:
- •suggestive medical history, and
- •specific IgE against birch pollen (CAP-Rast = 2), and
- •a positive SPT to birch pollen (the SPT is considered positive if it results in a wheal diameter of at least 3 mm and at least the size of histamine reference), and
- •a positive CPT with a birch pollen concentration of up to 10,000 SQ-units/mL.
- •Ten minutes after applying the drop, 4 symptom categories (eye redness, weeping, itching or burning, nose dripping or blockage) will be assessed and scored from 0 to 3 (0 = absent, 1 = mild, 2 = moderate, 3 = severe). The CPT is evaluated as positive if a sum score of 5 is reached at any of the scheduled concentration steps (X21X). The following concentrations will be applied: 100, 330, 1,000, 3,300, and 10,000 SQ-units/mL. Possibly, not all of these different concentration steps will be reached. The successively higher concentration will have to be applied only if the result of the immediately preceding test was negative or the result was < 5 score points.
- •Special criteria for patients with co-allergies
- •For all patients with co-allergies as a result of sensitization against grass and/or weed
- •pollen and/or perennial allergens (e.g. house dust mites, animal dander), all of the
- •following inclusion criteria must be fulfilled:
- •7. Patients do not suffer from typical symptoms against co-allergens,
- •8. Specific CAP-RAST against co-allergens < CAP-RAST against birch pollen (the difference has to be = 2), patients with co-allergens against animal dander can be
- •randomized even if the CAP RAST difference is = 2, but must not be exposed to the specific allergen,
- •9. Result of SPT against co-allergens < result of SPT against birch pollen.
- •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 patient will not be eligible for inclusion in this study if any of the following criteria
- •1. Acute and chronic conjunctivitis,
- •2. Infectious conjunctivitis,
- •3. History of significant clinical manifestations of allergy as a result of sensitization against grass or weed pollen and perennial allergens (e.g. house dust mites),
- •4. Symptoms due to co-allergies,
- •5. Persistent asthma, according to the Global Initiative for Asthma (GINA) Guidelines (see HSection 7.9.1H),
- •6. Acute or chronic inflammatory or infectious airway diseases including recurrent
- •acute or chronic sinusitis,
- •7. Chronic structural diseases of the lung (e.g. emphysema or bronchiectasis),
- •8. Diseases of the immune system including autoimmune and immune deficiencies,
- •9. Any disease, which prohibits the use of adrenaline (e.g. hyperthyroidism),
- •10. Severe uncontrolled diseases that could increase the risk for the patients
- •participating in the study, which include but are not limited to the following: cardiovascular insufficiency, any severe or unstable lung diseases, endocrine
- •diseases, clinically significant renal or hepatic diseases, or hematological
- •11. Any malignant disease during the previous 5 years,
- •12. Any significant abnormal laboratory parameter or alteration in the vital signs that
- •could increase the risk for the study patient,
- •13. Alcohol, drug, or medication abuse within the past year,
- •14. Severe psychiatric, psychological, or neurological disorders,
- •15. Use of immunotherapy against birch pollen within the last 5 years,
- •16. Topical and systemic treatment with ß-blockers,
- •17. Treatment with substances interfering with the immune system within 1 week prior
- •to Visit 2,
- •18. Use of tranquillizers or psychoactive drugs within 1 week prior to Visit 1,
- •19. Use of systemic corticosteroids within 3 months prior to Visit 1,
- •20. Immunization with vaccines within 7 days prior to Visit 2,
- •21. Patients with hypersensitivity to excipients of the investigational medicinal product,
- •22. Patients expected to be non-compliant and/or not co-operative,
- •23. Exposure to any investigational drug within one month or 6 half lives (whichever is
- •24. Patients who have already participated in this study,
- •25. Patients who are employees of the institution, or 1st grade relatives, or partners of
- •the investigator,
- •26. Any donation of germ cells, blood, organs, or bone marrow during the course of
- •27. Patients who are not contractually capable,
- •28. Nursing (lactating) women or a positive pregnancy test at Visit 1. In general, women of childbearing potential should be using highly effective contraception to
- •participate in clinical studies. A highly effective method of birth control is defined as one which results in a low failure rate (i.e., less than 1% per year) when used consistently and correctly, such as implants, injectables, combined oral contraceptives, some IUDs, sexual abstinence or vasectomised partner,
- •29. Persons who are jurisdictionally or governmentally institutionalized.
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