2024-519527-14-00已完成3 期
Multicenter, double-blind, randomized, placebo-controlled phase III clinical trial in parallel groups which evaluates the clinical efficacy and safety of immunotherapy with the purified major allergen Cup a 1, in patients with moderate/severe allergic rhino conjunctivitis with or without controlled asthma, sensitized to Cupressaceae
Diater Laboratorio De Diagnostico Y Aplicaciones Terapeuticas S.A.19 个研究点 分布在 1 个国家目标入组 150 人开始时间: 2024年12月19日最近更新:
适应症
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 150
- 试验地点
- 19
- 主要终点
- The efficacy of the treatment will be evaluated based on the symptom frequency and severity score together with the Combined Symptom and Medication Score (CSMS), which will be obtained through a questionnaire completed by the patient during 2 successive pollen seasons
研究概览
简要总结
Assessment of efficacy of specific immunotherapy with the purified and isolated protein Cup a 1 administered subcutaneously in patients sensitized to the allergen under study
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 0 years 至 65+ years（0-17 Years, 18-64 Years, 65+ Years）
- 接受健康志愿者
- 是
入选标准
- •Male or female from 12 to 65 years of age included
- •Obtaining informed consent to participate in the study, as well as legal guardians or legal representatives, if it is a minor
- •Moderate or severe allergic rhinitis or rhinoconjunctivitis, according to the modified ARIA classification, with or without asthma controlled by demonstrated sensitization to Cupresaceae
- •Cupressus or Cup a 1 IgE levels greater or equal than 2 kU/l (classes 3 to 6)
- •Positive skin prick test (≥3 mm in diameter) for Diater extract of Cupressaceae arizónica and Cup a 1, carried out in V0
- •Clinically relevant symptoms against cupresaceae.
- •Willingness to comply with all protocol requirements and availability for follow-up throughout the duration of the trial
- •Negative urine pregnancy test for women of childbearing potential (fertile from menarche to postmenopause, unless sterilized due to hysterectomy, bilateral salpingectomy, and bilateral oophorectomy) and willing to use effective contraception from 14 days before the first administration until 30 days after the last investigational product administration.
排除标准
- •Clinically relevant polysensitization: epithelia if they coexist with animals, mites, fungi and pollens at the investigator's discretion
- •Dermographism, pathologies or skin alterations that interfere with the evaluation of skin tests
- •Psychiatric disorder that prevents adequate compliance with the immunotherapy program
- •Pregnant or lactating woman
- •Simultaneous participation in another clinical trial
- •Any disease that interferes with the absorption or elimination of the investigational products
- •Chronic abuse of alcohol or any other type of substance that, in the opinion of the investigator, may interfere with the trial
- •Nasal or paranasal recent or scheduled pathology or surgery that may interfere with the trial, such as polyposis, at the investigator's discretion
- •Uncontrolled serious systemic diseases, such as autoimmune, cardiovascular, hyperthyroidism, liver disease or kidney failure, malignant tumours or chronic infection
- •Uncontrolled asthma despite optimal pharmacological treatment
- •Having received immunotherapy to cupresaceae or phylogenetically related allergens in the 5 years prior to the start of the trial
- •Being receiving immunotherapy against other different allergens than Cupressaceae concomitantly during the trial
- •Adrenaline use contraindication
- •Active tuberculosis
- •Severe atopic eczema
结局指标
主要结局
The efficacy of the treatment will be evaluated based on the symptom frequency and severity score together with the Combined Symptom and Medication Score (CSMS), which will be obtained through a questionnaire completed by the patient during 2 successive pollen seasons
The efficacy of the treatment will be evaluated based on the symptom frequency and severity score together with the Combined Symptom and Medication Score (CSMS), which will be obtained through a questionnaire completed by the patient during 2 successive pollen seasons
次要结局
- Evaluation of immunological markers: IL-10, IL-13, INF-ƴ, specific IgE and specific IgG4 against Cupressus arizonica and Cup a 1
- Symptom frequency and severity score. Results are compared between treatment arms and between pollen seasons
- Score for Rescue medication use
- Symptom-free days
- Medication-free days
- Extra visits and/or emergencies during the period of the clinical trial related to the pathology under study
- Skin follow-up skin test with Cupressaceae extract and Cup a 1
- Asthma and allergic rhinitis control assessed by ACT and modified ARIA
- Visual Analog Scale (VAS) for the state of health performed by the patient
- ESPRINT-15 questionnaire evaluation
- Conjunctival provocation against cupresaceae
- Frequency of adverse events (AEs), serious AAs (SAEs) and ADRs, particularly systemic events according to the World Allergy Organization (WAO) 2010 classification
研究者
Aída Gómez Cardeñosa
Scientific
Diater Laboratorio De Diagnostico Y Aplicaciones Terapeuticas S.A.
研究点 (19)
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