EUCTR2021-003014-39-ES进行中（未招募）1 期
Prospective, randomised, double-blind, double-dummy, placebo-controlled multicenter clinical trial of efficacy and safety with immunotherapy in patients with controlled mild to moderate allergic asthma and rhinitis/rhinoconjunctivitis, allergic to Dermatophagoides pteronyssinus and/or Dermatophagoides farinae.
Inmunotek, S.L.0 个研究点目标入组 400 人开始时间: 2021年10月13日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 400
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
- •1. Signed and dated Informed Consent Form (ICF).
- •2. Female or male aged 12 to 60 years, both included.
- •3. Confirmed clinical history of inhalation allergy (mild-moderate controlled intermittent or persistent asthma according to the definition of GEMA 5.0 and GINA 2020 and intermittent or persistent rhinitis / rhinoconjunctivitis according to the ARIA classification, caused by Dermatophagoides pteronyssinus and / or Dermatophagoides farinae). The asthma diagnosis will be valid up to 24 months prior to signing the informed consent.
- •4. Positive skin prick test (wheal major diameter = 5 mm) to a standardized allergen extract of Dermatophagoides pteronyssinus and/or Dermatophagoides farinae.
- •5. Specific IgE against a complete extract of D. pteronyssinus and/or D. farinae or any of the molecular components of allergenic sources with a value = 3.5 kU/L.
- •6. Women of childbearing age must have a urine pregnancy test negative result before enrolling the study.
- •7. Women of childbearing age must commit to using an adequate contraception method.
- •8. Capable of complying with dosage regimen.
- •9. Owning a smartphone to register symptoms and medication consumption.
- •10. A negative skin prick test to other aeroallergens with specific IgE < 3.5 kU/L with no clinical relevance
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 20
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 380
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1. Previous immunotherapy to any of the tested allergen during the last 5 years or any desensitization process in the last 2 years (ITO, milk, egg, ...) or currently receiving immunotherapy with any other allergen.
- •2. Positive skin prick test to other aeroallergens, except for intermittent symptoms due to temporary exposition to dander.
- •3. Those cases in which AIT would be a contraindication according to the criteria of European Allergy and Clinical Immunology Immunotherapy Subcommittee.
- •4. Uncontrolled or severe asthma and/or FEV1 <70% despite pharmacological treatment by the time of enrolment.
- •5. Intake of ß-blockers.
- •6. Use of immunosuppressive or biological drug.
- •7. Unstable patients by the time of enrolment (acute exacerbation asthma, respiratory infection, fever, acute pruritus, etc).
- •8. Patients who have suffered chronic urticaria during the last 2 years, severe anaphylaxis, or family history of angioedema.
- •9. Having any contraindication for the use of adrenaline (hyperthyroidism, heart disease, high blood pressure).
- •10. Other severe diseases not related to allergic asthma or rhinitis that could interfere in the study treatment or the follow-up (epilepsy, psychomotor agitation, diabetes, malformations, nephropathy) according to medical criteria.
- •11. Autoimmune diseases (thyroiditis, lupus, etc.), tumoral diseases or immunodeficiencies.
- •12. Participants that the investigator believes could not comply with the study protocol or have serious psychiatric disorders.
- •13. Known allergy to any of the ingredients of the study medication except for mites.
- •14. Lower respiratory tract diseases different from asthma as bronchiectasis or chronic obstructive pulmonary disease.
- •15. Breast-feeding or pregnant women.
- •16. Being immediate family of the investigator.
- •17. Concurrent participation in other clinical trials or prior participation within 30 days prior to inclusion.
- •18. History of serious systemic reactions, including food, Hymenoptera venom, medications, etc.
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