EUCTR2008-008448-26-LT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12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 skin prick test (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 conjunctival provocation test (CPT) with a birch pollen concentration
- •of 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 (21). The following concentrations will be applied: 100, 330,
- •1,000, 3,300 and 10,000 SQ-units/mL.
- •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 (perennial 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 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 Section 7.9.1),
- •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
- •22. Patients expected to be non-compliant and/or not co-operative,
- •23. Participation in any other clinical study within 30 days prior to Visit 2,
- •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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