EUCTR2020-001060-28-SE进行中（未招募）1 期
Documentation of efficacy and dose finding for intralymphatic allergen immunotherapy in a phase II/III randomized, parallel group, double blind placebo-controlled multisite field trial - ILIT.
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 675
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 have seasonal grass pollen induced rhino conjunctivitis during the two most recent seasons and a positive skin prick test resulting in a wheal diameter = 3 mm to ALK Soluprick Grass 225. The latter is important as it predicts that the patients IgE recognises allergens found in ALKs preparation for treatment, a crucial condition for treatment success.
- •Patients are adults; more than 18 years old on the day of first treatment,
- •Patients must be comfortable with digital data entry and have accepted and digitally approved the informed consent document.
- •Patient have to have sufficient symptoms during the grass pollen season to allow us to record an effect of the treatment; we will evaluate question 1 – 6 and 18 – 22 of their RHINE III and the sum of the retrospective RTSS questionnaires from the pre-screening tools to assess the severity of grass pollen dependent rhinoconjunctivitis and to identify or predict possible grass pollen dependent asthma affecting patients. For inclusion, patients have to have a retrospective RTSS score >7 on a scale of 0 – 18 (most severe). We will select patients with the highest RTSS score.
- •90% of patients included for the baseline year will be included in the treatment 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 600
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 75
排除标准
- •1 previous allergen immunotherapy for grass pollen allergy
- •2 Significant allergic sensitisation to mugwort (Artemisia vulgaris) or sensitisation with persistent exposure to pet animal allergens that results in allergic symptoms
- •3 Known or suspected allergy to additives to the study product; allergy to aluminium hydroxide or phenol
- •4 Depot steroid injection for treatment of allergic rhinoconjunctivitis
- •5 Upper airway disease (non-allergic sinusitis, nasal polyps)
- •6 uncontrolled asthma or severe asthma with post bronchodilator FEV1<70% of expected, decided by the investigator
- •7 Pulmonary disease, perennial or seasonal with daily use of more than 800 microgram inhaled budesonide/ day (or equivalent) or treatment with omalizumab or other biologics for allergy or asthma.
- •8 Pulmonary disease with post bronchodilator FEV1 < 70 % of predicted
- •9 Allergic reaction within the last 4 days or anaphylaxis last month before ILIT injections
- •10 severe Autoimmune or collagen disease
- •11 Disease or conditions rendering the treatment of anaphylactic reactions difficult (symptomatic coronary heart diseases, severe arterial hypertension and treatment with beta-blockers)
- •12 Known cardiovascular disease, i.e. not even NYHA class I.
- •13 Use of ACE-blockers. If ACE-blockers are used, they should be withdrawn after discussion with the Principal Investigator 2 weeks before first injection and until after the last injection
- •14 Recent or on-going hepatic or renal disease
- •15 All malignant diseases
- •16 Immuno- or chemotherapy during the last 15 years,
- •17 Increased bleeding tendency
- •18 Any other than study medication with an effect of interfering with the immune response
- •19 Chronic obstructive or restrictive lung disease
- •20 Skin diseases with barrier defect in the inguinal areas
- •21 Alcohol or drug abuse
- •22 Participation in another clinical study from visit 1-8.
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