2024-514524-16-00招募中3 期
Prospective, multicentre, randomized, double-blind, placebo-controlled, clinical trial of efficacy and safety with subcutaneous immunotherapy in patients with rhinitis/rhinoconjunctivitis with or without mild to moderate asthma sensitized to grasses and cupressaceae
Inmunotek S.L.19 个研究点 分布在 1 个国家目标入组 180 人开始时间: 2024年8月14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
- 180
- 试验地点
- 19
- 主要终点
- Combined symptom and medication score in rhinitis/rhinoconjunctivitis (RCSMS) during the pollen season and pollen peak of cupressaceae (January, February and March) and grasses (May and June).
研究概览
简要总结
The main objective of this clinical trial is to evaluate the clinical efficacy of subcutaneously administered polymerized allergen extracts compared to placebo in subjects with rhinitis/rhinoconjunctivitis according to the ARIA classification, with or without controlled intermittent or persistent (mild-moderate) asthma, as defined by GEMA 5.0 during pollen season and pollen peak of grasses and cupressaceae.
入排标准
- 年龄范围
- 0 years 至 64 years（0-17 Years, 18-64 Years）
- 接受健康志愿者
- 否
入选标准
- •Subject who has signed the informed consent form.
- •Subjects with negative skin test for co-seasonal pollens. In case specific IgE determination has been performed, the result must be < 3.5 kU/L and without relevant clinical signs.
- •Subjects with negative skin test for other aeroallergens (mites, dander, and fungi). In case specific IgE determination has been performed, the result must be < 3.5 kU/L and without relevant clinical signs.
- •Subjects of both sexes aged between 12 and 65 years.
- •Subjects with a confirmed clinical history of inhalation allergy (moderate-severe intermittent or persistent rhinitis and/or rhinoconjunctivitis according to the ARIA classification, with or without mild-moderate controlled intermittent or persistent asthma according to the GEMA 5.0 classification) caused by grass and cupressaceae allergy. The diagnosis of asthma will be valid from 12 months prior to signing the informed consent.
- •Subjects with a positive skin prick test (wheal major diameter ≥ 5 mm) to a standardised extract mixture of grass pollen (Phleum pratense, Holcus lanatus, Dactylis glomerata, Poa pratensis, Festuca elatior, Lolium perenne), or to one of the components of the mixture and a cupressaceae extract. In addition, the wheal major diameter must be greater than or equal to that of the histamine.
- •Specific IgE (CAP or Immulite) to a grass mixture or to one of the components of the grass mixture, preferably to Phleum pratense and cupressaceae or to one of the molecular components of the allergenic sources with a value > 3.5 KU/L.
- •Women of childbearing age (from menarche) must present a urine pregnancy test with negative result at the time of entry into the trial.
- •Women of childbearing age participating in the trial must agree to use an appropriate method of contraception. Medically acceptable methods of contraception are intrauterine devices inserted at least 3 months in advance, surgical sterilisation (e.g., tubal ligations), barrier methods, or the use of oral contraceptives.
- •Subjects able to comply with the dosing regimen.
- •Subjects with a smartphone to record symptoms and medication consumption.
排除标准
- •Subjects with positive skin prick test to other aeroallergens, except for dander with occasional exposure and symptomatology.
- •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 of potential severity and that may interfere with treatment and follow-up (epilepsy, psychomotor impairment, uncontrolled diabetes, malformations, multiple surgeries, nephropathies).
- •Subjects with autoimmune disease (thyroiditis, lupus, etc.), tumour diseases or diagnosed with immunodeficiencies.
- •Subject whose condition prevents him/her from offering cooperation and/or who has 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 members of investigators.
- •Pregnant or breastfeeding women.
- •Subjects with positive skin prick test for other aeroallergens, except for non-co-seasonal pollens with grasses and cupressaceae.
- •Subjects who have received immunotherapy to pollens in the last 5 years or are currently receiving immunotherapy with any allergen.
- •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. Also subjects with intermittent or persistent rhinitis/rhinoconjunctivitis with severe symptoms in whom discontinuation of oral or systemic antihistamine treatment is contraindicated.
- •Subjects who have previously exhibited a severe secondary reaction during diagnostic skin prick test.
- •Subjects on treatment with ß-blockers.
- •Clinically unstable subjects at the time of inclusion in the trial (acute asthma exacerbation, respiratory infection, febrile process, acute urticaria, etc.).
- •Subjects with chronic active urticaria, severe dermographism, severe atopic dermatitis, sunburn, active psoriasis with lesions in areas where skin prick test will be performed, or a history of hereditary angioedema.
结局指标
主要结局
Combined symptom and medication score in rhinitis/rhinoconjunctivitis (RCSMS) during the pollen season and pollen peak of cupressaceae (January, February and March) and grasses (May and June).
Combined symptom and medication score in rhinitis/rhinoconjunctivitis (RCSMS) during the pollen season and pollen peak of cupressaceae (January, February and March) and grasses (May and June).
次要结局
- Symptom free days in rhinitis/rhinoconjunctivitis and asthma
- Medication-free days in rhinitis/rhinoconjunctivitis and asthma
- Symptom score in rhinitis/rhinoconjunctivitis (RSS) during pollen season and pollen peak of grasses and cupressaceae.
- Medication score in rhinitis/rhinoconjunctivitis (RMS) during pollen season and pollen peak of grasses and cupressaceae.
- Combined symptom and medication score (ACSMS) during pollen season and pollen peak of grasses and cupressaceae.
- Asthma symptom score (ASS) during pollen season and pollen peak of grasses and cupressaceae.
- Asthma Medication Score (AMS) during pollen season and pollen peak of grasses and cupressaceae.
- Asthma and rhinitis/rhinoconjunctivitis symptom score (ARSS) during pollen season and pollen peak of grasses and cupressaceae.
- Asthma and rhinitis/rhinoconjunctivitis medication score (ARMS) during pollen season and pollen peak of grasses and cupressaceae
- Combined symptom and medication score in asthma and rhinitis/rhinoconjunctivitis (ARCSMS) during pollen season and pollen peak of grasses and cupressaceae.
- Asthmatic exacerbations: time to first occurrence of asthmatic exacerbation, number, duration and severity.
- Visual Analogue Scale (VAS)
- Immunological parameters (total IgE, specific IgE and specific IgG4).
- Asthma Control Questionnaire (ACQ-6).
- Rhinitis Follow-up Questionnaire (ESPRINT-15).
- Register of consumption of health resources.
- Safety of specific immunotherapy (Overall rate, severity, and ratio of any adverse event (AE) by administration and by subject; Evaluation of administration site reactions, systemic reactions and any medication administered for the treatment of AE)
研究者
Miguel Casanovas
Scientific
Inmunotek S.L.
研究点 (19)
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