2025-524676-32-00招募中3 期
International, multicenter, blinded phase III clinical trial to assess the diagnostic efficacy of the skin prick test from ROXALL (SPT-RX) with different allergen extract solutions for in vivo diagnosis of IgE mediated allergies
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 140
- 试验地点
- 10
- 主要终点
- The primary efficacy endpoint will be related to the two main parameters for each allergenic extract that allow for distinction between allergic from non-allergic patients and which should be above 0.80 as lower limit of 90% CI each: a. Sensitivity (S). b. Specificity (E)
研究概览
简要总结
The purpose of this clinical trial is to assess the diagnostic performance of SPT-RX solutions containing different allergen extracts administered by skin prick-test procedure, by means of the establishment of the sensitivity and specificity for each allergen extract.
入排标准
- 年龄范围
- 18 years 至 64 years（18-64 Years）
- 接受健康志愿者
- 否
入选标准
- •Patients who signed and dated informed consent form obtained prior to any study-specific examination.
- •Female or male patients between 18 and 65 years of age at the time of signing the informed consent form.
- •Positive result (≥ 3 mm) in a skin prick test performed with a positive control (histamine dihydrochloride 10 mg/mL) used in routine clinical practice, and negative result (< 2 mm) in a skin prick test performed with a negative control (glycerinated phenolated saline solution) used in routine clinical practice.
- •Assumed compliance and ability of the patient to understand the patient's diary and to follow the instructions of the study staff.
- •Patients suffering from rhinitis / rhinoconjunctivitis, with well-controlled mild-to-moderate asthma or without asthma, due to the exposure to any of the allergen sources under investigation, for at least 2 years in case of seasonal allergenic sources or for at least 1 year in case of perennial allergenic sources.
- •Patients with a previous diagnosis of IgE-mediated allergy (type I) to any of the allergen sources under investigation verified by: a Retrospective Rhinoconjunctivitis Total Symptom Score (RRTSS) ≥ 1, (0-3 scale), according to Pfaar et al. (2014), during the period of highest exposure to the allergen source preceding the enrolment and, a positive skin prick test (mean wheal sdiameter ≥ 3 mm) when tested with a biologically standardized extract ued in routine clinical practice and, specific IgE (CAP (EAST) class ≥ 3 (i. e. value ≥ 3.50 kU/L)
- •In addition, for patients with a negative case history (“true non-allergic” patients) to any of the allergen extracts under investigation: • Non-atopic patients or patients sensitized to any allergen extract but those under investigation1 or any cross-reactive allergen source, verified by: a negative skin prick test (mean wheal diameter < 3d mm) to any of the allergen sources under investigation when tested with a biologically standardized extract prouct used in routine clinical practice and IgE (CAP (EAST) class < 1 (i. e. value < 0.35 kU/L) to the allergen source.
排除标准
- •Patients who are using drugs that may interfere with the SPTs (according to Bousquet J. 1992, Rüeff F. 2011 and Heinzerling et al. 2013)
- •Skin disorders such as dermographism, atopic dermatitis, urticaria, cutaneous mastocytosis or tattoos at the test application area.
- •Contraindication for adrenaline (for example, acute or chronic symptomatic coronary heart disease, severe hypertension, hyperthyroidism, glaucoma).
- •Patients with any other contraindications for performing skin prick test.
- •Risk of non-compliance by the patient with the study procedures
- •Relationship or dependence with the sponsor and/or investigator, legal incapacity, or patients who are jurisdictional or governmentally institutionalized.
- •Patients with any severe psychiatric and psychological disorders, including impairment of cooperation (e. g., alcohol or drug abuse).
- •Subjects currently participating in another clinical trial.
- •In addition, for patients with a negative case history (“true non-allergic” patients): • Patients sensitized to any allergen source with demonstrated cross-reactivity with the allergen sources under investigation.
- •Only for asthmatic patients, severe, partly controlled or uncontrolled asthma according to the GINA guideline (Global Initiative for Asthma, 2025) or forced expiratory volume (FEV1) in one second ≤ 80 % of predicted normal value or known high degree of bronchial hyperreactivity.
- •Patients with hypersensitivity to any of the excipients of the SPT-RX allergen extract solutions under investigation.
- •Patients receiving allergen immunotherapy (AIT) or who received AIT in the past to any of the allergen extracts under investigation or to any cross-reactive allergen extract.
- •Any severe generalised disease (liver, kidney, heart, metabolic disease) or autoimmune disease, immune-defect, including immunosuppression, immune-complex-induced immunopathy, or any infection or inflammation of the respiratory tract at the time of inclusion.
- •Patients receiving treatment with beta-blockers.
- •Completed or ongoing treatment with an anti-IgE-antibody (like Omalizumab) and/or checkpoint inhibitor.
- •Patients at high risk of anaphylaxis according to their medical history.
- •Pregnancy and/or breastfeeding.
研究组 & 干预措施
SPT-RX-DPT
Test
干预措施: SPT-RX-DPT (Drug)
SPT-RX-PAR
Test
干预措施: SPT-RX-PAR (Drug)
SPT-RX-OLE
Test
干预措施: SPT-RX-OLE (Drug)
SPT-RX-BET
Test
干预措施: SPT-RX-BET (Drug)
SPT-RX-PHL
Test
干预措施: SPT-RX-PHL (Drug)
结局指标
主要结局
The primary efficacy endpoint will be related to the two main parameters for each allergenic extract that allow for distinction between allergic from non-allergic patients and which should be above 0.80 as lower limit of 90% CI each: a. Sensitivity (S). b. Specificity (E)
The primary efficacy endpoint will be related to the two main parameters for each allergenic extract that allow for distinction between allergic from non-allergic patients and which should be above 0.80 as lower limit of 90% CI each: a. Sensitivity (S). b. Specificity (E)
次要结局
- Positive Predictive Value (PPV): is the probability that patients who tested positive on the SPT-RX under investigation are truly allergic to a specific allergen source
- Negative Predictive Value (NPV): is the probability that patients who tested negative on the SPT-RX under investigation are truly non-allergic to a specific allergen source
- Positive Likelihood ratio: is the probability that a patient with the disease will have a positive test result, divided by the probability that a patient without the disease will have a positive result.
- Negative Likelihood ratio: is the probability that a patient with the disease will have a negative test result, divided by the probability that a patient without the disease will have a negative result.
- Efficiency (or Accuracy) is the percentage of patients for whom the test results coincide with the clinical history.
- Wheal size: the mean diameter size, in mm, induced by each allergen extract and by positive and negative tested controls. According to Ruëff et al. (2011) and Heinzerling et al. (2013), a wheal diameter ≥ 3 mm will be considered a positive result.
研究者
Dr. Begoña Madariaga
Scientific
ROXALL Medizin GmbH
研究点 (10)
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