2024-514090-21-00招募中3 期
Prospective, multicenter, randomized, double-blind, placebo-controlled, efficacy and safety clinical trial with subcutaneous immunotherapy in patients with rhinitis/rhinoconjunctivitis with or without mild to moderate asthma sensitized to Dermatophagoides pteronyssinus and/or Dermatophagoides farinae
Inmunotek S.L.27 个研究点 分布在 1 个国家目标入组 150 人开始时间: 2024年8月16日最近更新:
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 150
- 试验地点
- 27
- 主要终点
- To evaluate the efficacy of allergen extracts in subjects with moderate-severe intermittent or persistent rhinitis/rhinoconjunctivitis with or without controlled mild to moderate intermittent or persistent asthma sensitised to Dermatophagoides pteronyssinus and/or Dermatophagoides farinae, aged 12-65 years, by assessing the combined symptom score and medication intake, between baseline and end of the trial.
研究概览
简要总结
The main objective of this trial is to evaluate the clinical efficacy of subcutaneously administered polymerised allergen extracts compared to placebo in subjects with moderate-severe intermittent or persistent rhinitis/rhinoconjunctivitis according to the ARIA classification with or without mild-moderate controlled intermittent or persistent asthma as defined by GEMA 5.0.
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
- •Subjects who have signed the informed consent form.
- •Subjects diagnosed with asthma according to GEMA 5.
- •Subjects able to comply with the dosing regimen.
- •Subjects owning a smartphone to record symtom and medication.
- •Subjects of both sexes aged between 12 and 65 years old.
- •Subjects with a confirmed clinical history of inhalant allergy (intermittent or persistent moderate-severe rhinitis and/or rhinoconjunctivitis according to the ARIA classification with or without controlled intermittent or persistent mild-moderate asthma according to the GEMA 5.0 definition) caused by allergy to Dermatophagoides pteronyssinus and/or Dermatophagoides farinae.
- •Subjects who have had a prick test result ≥ 5 mm in diameter greater for Dermatophagoides pteronyssinus and/or for Dermatophagoides farinae. Positive and negative control test results must be consistent.
- •Subjects with a specific IgE value > 3.5 KU/L (ImmunoCAP® or Immulite) for complete extract of Dermatophagoides pteronyssinus and/or for Dermatophagoides farinae or for some of the molecular components of these allergenic sources
- •Subjects shall preferably be monosensitised to the study allergens. In the case of subjects sensitised to other aeroallergens, only those with the following characteristics (results valid 12 months prior to signing the informed consent) may be included in the study: (a) Subjects with positive skin test to Blomia tropicalis and Lepidoglyphus destructor, whose maximum specific IgE values are 3.5 KU/L. b) Subjects with negative skin test. Subjects with positive skin tests for epithelia may be included in the study, provided that they have occasional exposure and symptomatology. c) Subjects with positive skin tests for pollens, whose specific IgE values do not exceed or equal the values for the study allergens and who, in addition, do not present exacerbations in the pollen season. The maximum value of specific IgE for these allergens is 17.5 KU/L.
- •Subjects with negative skin test for fungus.
- •Women of childbearing age (since menarche) should submit a negative urine pregnancy test at the time of entry into the trial, prior to administration of the first dose of investigational medicinal product.
- •Women of childbearing potential participating in the trial should agree to use an adequate method of contraception, defined as any act, device, or medication to prevent conception or a viable pregnancy, during the trial if sexually active.
排除标准
- •Subjects who have received previous immunotherapy in the previous 5 years to epithelia, fungi and mites.
- •Subjects with autoimmune disease (thyroiditis, lupus, etc.), tumour diseases or diagnosed with immunodeficiencies.
- •Subjects whose condition prevents them from cooperating or who present severe psychiatric disorders.
- •Subjects with known allergy to components of the investigational medicinal product other than the allergen.
- •Subjects with lower respiratory tract diseases other than asthma such as emphysema or bronchiectasis.
- •Subjects who are immediate family relatives of researchers.
- •Pregnant or breastfeeding women.
- •Subjects in whom immunotherapy may be subject to absolute general contraindication according to the criteria of the Immunotherapy Committee of the Spanish Society of Allergy and Clinical Immunology and the European Allergy and Clinical Immunology Immunotherapy Subcommittee.
- •Subjects with severe or uncontrolled persistent asthma, with an FEV1 < 70% of baseline despite adequate pharmacological treatment at the time of inclusion in the trial.
- •Subjects who have previously exhibited a severe secondary reaction during diagnostic skin prick tests.
- •Subjects on ß-blocker treatment.
- •Subjects who are clinically unstable at the time of inclusion in the trial (acute asthmatic exacerbation, respiratory infection, febrile process, acute urticaria, etc).
- •Subjects with active chronic urticaria, severe dermographism, severe atopic dermatitis, sunburn, active psoriasis with lesions in areas where skin testing will be performed, or a history of hereditary angioedema.
- •Subjects with any pathology in which the administration of adrenaline is contraindicated (hyperthyroidism, hypertension, heart disease, etc.).
- •Subjects with any other disease not related to moderate rhinoconjunctivitis or asthma, but potentially serious and which may interfere with treatment and follow-up (epilepsy, psychomotor alteration, uncontrolled diabetes, malformations, multioperative, nephropathy, etc.).
结局指标
主要结局
To evaluate the efficacy of allergen extracts in subjects with moderate-severe intermittent or persistent rhinitis/rhinoconjunctivitis with or without controlled mild to moderate intermittent or persistent asthma sensitised to Dermatophagoides pteronyssinus and/or Dermatophagoides farinae, aged 12-65 years, by assessing the combined symptom score and medication intake, between baseline and end of the trial.
To evaluate the efficacy of allergen extracts in subjects with moderate-severe intermittent or persistent rhinitis/rhinoconjunctivitis with or without controlled mild to moderate intermittent or persistent asthma sensitised to Dermatophagoides pteronyssinus and/or Dermatophagoides farinae, aged 12-65 years, by assessing the combined symptom score and medication intake, between baseline and end of the trial.
次要结局
- Asthma Medication Score (AMS)
- Rhinitis/rhinoconjunctivitis symptom score (RSS)
- Rhinitis/rhinoconjunctivitis medication score (RMS)
- Asthma combined symptom and medication score (ACSMS)
- Asthma symptom score (ASS)
- Asthma and Rhinitis/Rhinoconjunctivitis Symptom Score (ARSS)
- Asthma and rhinitis/rhinoconjunctivitis medication score (ARMS)
- Combined symptom and medication score for asthma and rhinitis/rhinoconjunctivitis (ARCSMS)
- Symptom-free days and medication-free days for rhinitis/rhinoconjunctivitis and for asthma
- Time since first onset of asthma exacerbation, number, severity, and duration of asthma exacerbations
- Quality of life using the ESPRINT-15 questionnaire in rhinitis and asthma monitoring using the asthma symptom control questionnaire (GINA)
- Visual Analogue Scale (VAS)
- Serum immunological parameters (total IgE, specific IgE and specific IgG4)
- Consumption of health resources
- Safety of specific immunotherapy (Overall rate, severity, and ratio of any adverse events (AEs) per administration and per subject and assessment of administration site reactions, systemic reactions and any concomitant medication administered for the treatment of AEs)
研究者
Medical Department
Scientific
Inmunotek S.L.
研究点 (27)
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