EUCTR2013-005550-30-DE进行中（未招募）1 期
A randomized, double-blind, placebo-controlled (DBPC), parallel group study to assess the clinical efficacy and safety of SUBLIVAC FIX Birch immunotherapy in patients suffering from allergic rhinitis/rhinoconjunctivitis caused by birch pollen, followed by an optionalopen label, one group safety-extension period. SB/0042 study - SUBLIVAC FIX Birch Phase III short-term efficacy
HAL Allergy B.V.0 个研究点目标入组 400 人开始时间: 2014年4月1日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 400
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. Signed informed consent
- •2. Age = 18 and =65 years
- •3. Moderate-to-severe birch pollen induced allergic rhinitis/rhinoconjunctivitis based on ARIA classification for at least 2 consecutive years24
- •4. FEV1 > 70% (of predicted value) for patients with a history of asthma, FEV1 > 70% or PEF > 80% (of predicted value) for patients without a history of asthma
- •5. Positive SPT for birch pollen (mean wheal diameter = 3mm compared to negative control; negative control should be negative; histamine control should be positive (mean wheal diameter = 3mm)) assessed during screening
- •6. Serum specific anti-birch IgE concentration >0.7 U/ml
- •Inclusion criteria to be assessed at Visit 2 before randomisation:
- •7. Patients should be willing and capable to complete an e-diary daily during the birch pollen season (= 60% compliance in completion between Visit 1 and 2).
- •8. A positive Nasal Provocation Test to birch pollen (per appendix 3) at Visit 2 (Lebel score = 6)25 or a documented positive test within 1 year before start of treatment
- •Inclusion criteria for Safety-Extension period:
- •1 Signed updated informed consent including Safety-Extension period details
- •2 Patients that completed the double blind period of the study
- •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 360
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 40
排除标准
- •1. Patients sensitized and symptomatic to pets should not be included if they are regularly exposed to pets
- •2. Specific immunotherapy (SCIT or SLIT) with birch pollen or a cross-reacting allergen within the last 5 years
- •3. SPT positive (mean wheal diameter = 3mm compared to negative control; negative control should be negative; histamine control should be positive (mean wheal diameter = 3mm)) patients to allergen(s) other than birch pollen, in the absence of a negative provocation test for this allergen(s) (within 1 year), who are expected to have clinically relevant symptoms during the birch pollen season
- •4. Completed unsuccessful allergen-specific immunotherapy (SCIT or SLIT) within the last 5 years
- •5. (Ongoing) allergen-specific immunotherapy (SCIT or SLIT) with any allergen(s) during the study period
- •6. Vaccination one week before start of treatment and/or during the up-dosing phase
- •7. Treatment with experimental products within the last 3 months or biologicals (including anti-IgE or TNF- a treatment) within the last 6 months or during the study
- •8. Uncontrolled asthma or other active respiratory diseases
- •9. Clinically significant chronic sinusitis, ocular infection or severe inflammation of the oral mucosa
- •10. Severe immune disorders (including auto-immune diseases) and/or diseases requiring immunosuppressive drugs
- •11. Active malignancies or any malignant disease in the last 5 years
- •12. Acute or chronic disease that in the opinion of the investigator is an additional risk for the patients, including but not limited to the following: cardiovascular insufficiency, any severe or unstable lung diseases, endocrine disorders, clinically significant renal or hepatic diseases, or haematological disorders
- •13. Diseases with a contra-indication for the use of adrenaline (e.g. hyperthyroidism, glaucoma)
- •14. Use of systemic corticosteroids 4 weeks before the study
- •15. Treatment with systemic or local ß-blockers
- •16. Known hypersensitivity to any of the excipients (Disodium phosphate dihydrate, Sodium dihydrogen phosphate dehydrate, Aminocaproic acid, Peppermint oil, Caramel Colorant or Glycerol)
- •17. A positive urine pregnancy test, lactation or inadequate contraceptive methods (adequate methods: oral contraceptives, IUD, condom use and having no sexual relationship with a man)
- •18. Alcohol-, drug or medication abuse
- •19. Lack of co-operation or compliance
- •20. Severe psychiatric, psychological, or neurological disorders
- •21. Any physical or mental condition that precludes administration or allergen-specific immunotherapy, compliance or participation in a clinical trial
- •22. Patients who are employees of the department, 1st grade relatives, or partners of the investigator
- •23. Patients who have planned holidays outside the country for more than 7 continuous days during the defined pollen season (1st of March till 31st of May)
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