EUCTR2015-002409-13-DE进行中（未招募）1 期
A multicenter, randomized, open-label clinical trial to evaluate safety and tolerability of a year-round initiation of specific immunotherapy with an aluminum hydroxide adsorbed allergoid preparation of 6-grasses in patients with moderate to severe seasonal rhinitis or rhinoconjunctivitis with or without controlled asthma. - SuBITo
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 240
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.Written informed consent given according to local requirements before any trial-related activities started (a trial-related activity is any procedure that would not have been performed during the routine management of the patient).
- •2.Legally competent male or female outpatient
- •3.Age = 18 and = 65 years
- •4.IgE-mediated seasonal allergic rhinitis or rhinoconjunctivitis with or without controlled allergic asthma caused by grass pollen as confirmed by the following test procedures:
- •Skin prick test (SPT):
- •wheal for 6-grasses pollens = 3 mm in diameter
- •Histamine wheal = 3 mm (positive control)
- •NaCl reaction < 2 mm (negative control)
- •Immunoassay result for specific IgE = 0.70 kU/L to grass mix/earlybloom (central lab)
- •5.Main symptoms of allergic rhinitis or rhinoconjunctivitis between the months of May to August of at least 1 month with respective grass pollen exposure in the previous 2 seasons
- •6.Previous treatment with anti-allergic treatment for at least 2 seasons prior to enrolment
- •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 240
- •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.Unable to understand and comply with the requirements of the trial, as judged by the investigator
- •2.Currently participating in any other trial or participating in any other trial within 30 days before inclusion into this trial
- •3.Low compliance or inability to understand instructions/trial documents
- •4.Involvement in the planning and conduct of the trial
- •5.Employee of Allergopharma GmbH & Co. KG or of one of the trial sites or any relationship with the sponsor or investigator
- •6.Mentally disabled
- •7.Institutionalized due to an official or judicial order
- •For females with childbearing potential (i.e. females who are not chemically or surgically sterilized or females who are not postmenopausal):
- •8.Positive pregnancy test at screening or during the course of the trial
- •9.Use of an unacceptable or unreliable contraceptive method during the trial, as judged by the investigator (reliable and highly effective methods of birth control defined as failure rate less than 1% per year)
- •10.Wish to breastfeed
- •11.Wish to become pregnant during the course of the trial
- •Immunotherapy criteria:
- •12.AIT with grass pollen within the last 5 years
- •13.Currently under any sort of immunotherapy
- •14.AIT with unknown allergen within the last 5 years
- •Diseases and health status:
- •15.Clinically relevant chronic rhinoconjunctival or respiratory symptoms related to other reasons than allergy
- •16.Peak expiratory flow (PEF) < 70% of predicted normal (ECSC) under adequate asthma treatment according to GINA 2015
- •17.Uncontrolled or partly controlled asthma according to GINA 2015
- •18.Perennial and continuously treated asthma
- •19.Rhinoconjunctival atopic symptoms for 20 years or longer
- •20.Severe acute or chronic diseases (e.g. active tuberculosis, diabetes mellitus type I, malignant neoplasia, chronic renal failure), severe inflammatory diseases (liver, kidneys)
- •21.Autoimmune diseases, immune defects including immunosuppression, immune-complex-induced immunopathies (e.g. HIV, post-transplant patients, lupus erythematodes [SLE], vitiligo, Grave’s disease)
- •22.Severe psychiatric and psychological disorders including impairment of cooperation (e.g. alcohol or drug abuse)
- •23.Recurrent seizures
- •24.Irreversible secondary alterations of the reactive organ (e.g. emphysema, bronchiectasis)
- •25.Laboratory values 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:
- •26.Use of beta-blockers (locally or systemically)
- •27.Contraindication for use of adrenaline (e.g. acute or chronic symptomatic coronary heart disease, severe hypertension)
- •28.Completion or ongoing treatment with anti-IgE-antibody
- •29.Completion or ongoing long-term treatment with tranquilizer or other psychoactive drugs
- •30.Use of prophylactic or continuous treatment with anti-allergic medication in fixed (constant) dose during the pollen season
研究者
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