NCT05395689招募中3 期
Efficacy and Safety Assessment of a Subcutaneous Immunotherapy (Beltavac®) With Polymerized Allergenic Extract From House Dust Mites in Patients With Allergic Rhinitis/Rhinoconjuntivitis
适应症
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 350
- 试验地点
- 23
- 主要终点
- The combined nasal symptom and medication score
研究概览
简要总结
The trial is performed to assess efficacy and safety of Beltavac with polymerized extract of house dust mites in allergic Rhinoconjunctivitis associated or not with asthma
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 12 Years 至 65 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Written informed consent, signed and duly dated.
- •Man or woman between 12 and 65 years old (both included).
- •Patient with moderate or severe symptoms of persistent rhinitis according to the ARIA Guide, associated or not with well or partially controlled asthma according to the GEMA 5.0 Guide.
- •Confirmation of sensitization to DPT or DF with a positive prick test (mean papule diameter greater than or equal to 3 mm) with a commercial standardized allergenic extract and a serum extract-specific IgE value of class 3 or higher (> 3.5 kU / L) within the 6 months prior to the study.
- •Negative pregnancy test.
- •Nasal symptom and medication combined scale score ≥ 1.5 during the screening phase.
排除标准
- •Concomitant sensitization to allergens other than dust mites if clinically relevant symptoms are anticipated that may interfere with study evaluation periods at the discretion of the investigator.
- •Poorly controlled asthma according to the GEMA 5.0 guideline
- •Severe asthma, that is, those who during the last months have controlled their asthma according to therapeutic step 5-6 of the GEMA 5.0 guideline.
- •Autoimmune diseases or immunodeficiency.
- •Malignant neoplasms, serious cardiovascular disease, serious mental illness or other relevant chronic diseases that may interfere with the results of the study.
- •Clinical history of anaphylaxis with cardio / respiratory symptoms.
- •Hypersensitivity to any of the excipients of the investigational product.
- •Immunosuppressive medication during the last 6 months before the inclusion of patients and until the end of the study.
- •Treatment with beta-blockers during the study.
- •Patients who have previously received immunotherapy with allergenic dust mite extract or other extracts and have failed within the last 5 years.
- •Patients with immunotherapy with allergens other than dust mites during the study period.
- •Patients who receive any other vaccine one week before the start of treatment or awaiting the second dose of vaccine against COVID-
- •Pregnant or nursing patients.
结局指标
主要结局
The combined nasal symptom and medication score
时间窗: 12 months of treatment
The symptoms assessed are: itchy nose, sneezing, runny nose, and blocked nose (all rated from 0-3). The medication score is 1 for oral and/or topical antihistamines, 2 for intranasal corticosteroids, and 3 for oral corticosteroids. The scores from the nasal symptoms are added and divided by 4 to a total daily symptom score from 0-3.Final score range from 0 to 6, higher score meaning a worse outcome.
次要结局
- Score of the nasal symptoms scale(12 months of treatment)
- Score of the specific medication scale(12 months of treatment.)
- VAS score (completed by the patient and the investigator)(12 months of treatment.)
- RCAT questionnaire(12 months of treatment.)
- Values in serum of specific IgE and IgG4(12 months of treatment.)
- ACT questionnaire(12 months of treatment)
- Percentage of days without symptoms or medication(12 months of treatment)
- Mini-RQLQ questionnaires(12 months of treatment.)
- Number of local and systemic reactions.(13 months of study follow up)
- Cost-effectiveness analysis(13 months of study follow up)
- The combined asthma symptom and medication score(12 months of treatment)
- PEF(12 months of treatment)
研究者
研究点 (23)
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