EUCTR2013-003095-12-DE进行中（未招募）1 期
Double-blind phase IV multicentre clinical trial to evaluate and compare specific and non specific effects of SCIT by use of an Environmental Challenge Chamber after treatment with Allergovit® grasses or Allergovit® birch in patients with grass and birch pollen allergy - Phase IV study with Allergovit® grasses - Allergovit® birch comparing specific & unspecific effects
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
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.Has the patient given informed consent according to local requirements before any trial-related activities? (A trial-related activity is any procedure that would not have been performed during the routine management of the patient.)
- •2.Is the patient a legally competent male or female outpatient?
- •3.Is the patient aged 18 to 65 years?
- •4.Does the patient suffer from IgE-mediated seasonal allergic rhinoconjunctivitis with or without asthma caused by grass pollen and birch pollen allergy documented by
- •a)Skin prick test wheal for grass pollen = 3mm in diameter
- •b)Skin prick test wheal for birch pollen = 3mm in diameter
- •c) Histamine wheal = 3mm
- •d) NaCl control reaction < 2mm?
- •5. Has the patient an immunoassay result
- •a)for sIgE > 0.70 kU/L to grass pollen allergens?
- •b)for sIgE > 0.70 kU/L to birch pollen allergens?
- •6.Has the patient main discomfort due to allergic rhinoconjunctivitis in the months with respective grass pollen and birch pollen exposure?
- •7.Has the asthma status been checked?
- •8.Has the patient been treated with anti-allergic medications for at least 2 years prior to enrolment?
- •Prior to the treatment phase the Sponsor will assess following criterion:
- •9.Does the patient suffer from relevant symptoms (adj. AUC of TNSS of at least 10) documented during the pre-treatment exposure with birch pollen allergens in the ECC?
- •10.Does the patient suffer from relevant symptoms (adj. AUC of TNSS of at least 10) documented during the pre-treatment exposure with grass pollen allergens in the ECC?
- •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 280
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •General criteria:
- •1.Is the patient unable to understand and comply with the requirements of the trial, as judged by the investigator?
- •2.Is the patient currently participating in any other trial or has the patient participated in any other trial within 30 days before inclusion in this trial?
- •3.Does the patient show low compliance or inability to understand instructions/trial documents?
- •4.Is/was the patient involved in the planning and conduct of the trial?
- •5.Is the patient an employee of Allergopharma GmbH & Co. KG or of one of the trial sites?
- •6.Is the patient in any relationship of dependence with the sponsor and/or with the investigator?
- •7.Has the patient been previously enrolled or randomised to treatment in the present trial?
- •8.Is the patient mentally disabled?
- •9.Is the patient institutionalised due to an official or judicial order?
- •For females with childbearing potential (i.e. females who are not chemically or surgically sterilised or females who are not post-menopausal):
- •10.Does the patient have a positive pregnancy test at screening?
- •11.Does the patient use an unacceptable and unreliable contraceptive method during the trial, as judged by the investigator? (Reliable and highly effective methods of birth control with a low failure rate (i.e. less than 1% per year) when used consistently and correctly are, e.g., implants, injectables, combined oral contraceptives, some IUDs, sexual abstinence or vasectomised partners.)
- •12.Does the patient wish to breast feed?
- •13.Is the patient seeking to become pregnant during the course of the study?
- •Immunotherapy criteria:
- •14.Has the patient undergone previous specific immunotherapy with grass pollen or birch pollen allergens in any formulation?
- •15.Is the patient currently undergoing any sort of specific immunotherapy?
- •16.Has the patient ever undergone specific immunotherapy with unknown allergens?
- •Diseases and health status:
- •17.Does the patient suffer from clinically relevant rhinoconjunctival or respiratory symptoms related to other reasons which interfere with the assessments in the ECC?
- •18.Has the patient a PEF/FEV1 < 80% of predicted normal (ECSC)?
- •19.Has the patient uncontrolled or partly controlled asthma according to GINA 2012?
- •20.Does the patient suffer from perennial and continuously treated asthma?
- •21.Does the patient suffer from rhinoconjunctival atopy symptoms for 20 years or longer?
- •22.Does the patient suffer from severe acute or chronic diseases (e.g. Diabetes mellitus type I, malignant neoplasia, chronic renal failure), severe inflammatory diseases (liver, kidneys)?
- •23.Does the patient suffer from autoimmune diseases, immune-defects including immune-suppression, immune-complex-induced immunopathies (e.g. HIV, post-transplant patients, lupus erythematodes [SLE], Grave’s disease)?
- •24.Does the patient suffer from severe psychiatric and psychological disorders including impairment of cooperation (e.g. alcohol or drug abuse)?
- •25.Does the patient suffer from recurrent seizures?
- •26.Has the patient an anatomic abnormality that interferes with assessment of Total Nasal Symptom Score (TNSS) if being assessed in the environmental challenge chamber?
- •27.Has the patient any laboratory value greater than Grade 1 according to the FDA Guidance for Industry (Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials)?
- •Medications:
- •28.Is the patient permanently needing any me
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