EUCTR2007-000823-16-DE进行中（未招募）不适用
A multicenter, multinational, placebo-controlled, double-blind, randomized study to evaluate efficacy and safety of a perennial, sublingual specific immunotherapy in patielnts with rhinoconjunctivitis with/without controlled asthma caused by grass pollen (Allegra-6) - ALLEGRA6
Allergopharma Joachim Ganzer KG0 个研究点目标入组 226 人开始时间: 2007年6月12日最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 226
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
- •Male and female outpatients
- •Age18 - 65 years
- •IgE-mediated seasonal allergic rhinoconjunctivitis with or without controlled asthma caused by grass pollen documented by
- •Positive skin prick test wheal for grass pollen > 5mm in diameter and
- •Positive histamine (0.1% histamine free base) wheal >3mm and a negative NaCl control reaction <3mm
- •Positive EAST > 1.5kU/L to grass pollens and
- •Proven clinical relevance of grass pollen allergy by positive conjunctival provocation testing with grass pollen allergens and
- •Main discomfort in the months May, June, July of the year
- •For female patients with childbearing potential: (i.e., females are not chemically or surgically sterilised or females who are not post-menopausal) must have a negative serum pregnancy test before the baseline phase.
- •Female patients must have a negative serum pregnancy test at enrolment and be willing to use a reliable method of birth control (i.e., double barrier method, oral contraceptive, implant, dermal contraception, long-term inject able contraceptive, intrauterine device, or tubar ligation) during the study, as judged by the investigator.
- •Be able to understand and comply with the requirements of the study, as judged by the investigator
- •For patients with bronchial asthma at entry: confirmed diagnosis and asthma classification as controlled according” GINA guidelines (version 2006).
- •At the Beginning of the treatment phase:
- •Rhinoconjunctivitis symptoms documented in the patients diary during the baseline season
- •Patients must have demonstrated a Symptom - Score of at least 4 every day
- •during the week following the peak pollen count in the baseline season.
- •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
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Previous or other current specific immunotherapy with grass pollen allergens in any formulation
- •For allergens which interfere with the grass pollen season: (Plantain, Nettle, Birch, Olive tree, Parietaria officinalis, Alternaria alternata, Cat epithelia, Dermatophagoides farinae, Dermatophagoides pteronyssinus):
- •Sensitisation in the Skin Prick Test: wheal diameter of respective interfering allergen = wheal diameter of grass pollen allergen
- •Previous course of hyposensitisation against grass pollen or other allergens that are not known
- •Patients who have undergone an unsuccessful course of specific immunotherapy with any allergen
- •Clinically relevant rhinoconjunctival or respiratory symptoms related to other reasons
- •PEF or FEV1 < 80% of predicted normal (ECCS)
- •Uncontrolled or partly controlled asthma according GINA guidelines (version 2006)
- •Febrile infections or inflammation of the respiratory tract at the time of inclusion
- •Severe acute or chronic diseases, severe inflammatory diseases (liver, kidneys, metabolic diseases)
- •Autoimmune diseases, immune-defects including immune-suppression, immune-complex-induced immunopathies
- •Severe psychiatric and psychological disorders including impairment of cooperation (e.g. alcohol or drug abuse)
- •Treatment with beta-blockers (locally and systemically)
- •Recurrent seizures
- •Pregnancy and lactation period
- •Concurrent participation in any other clinical trial or participation in any other clinical trial during the previous 30 days
- •Low compliance or inability to understand instructions/study documents
- •Involvement in the planning and conduct of the study (applies to both) Allergopharma Joachim Ganzer KG staff or staff at the study site.
- •Patients being in any relationship of dependence with the Sponsor and/or with the Investigator
- •Previous enrolment or randomisation of treatment in the present study
- •Completed or ongoing treatment with anti-IgE-Antibody
- •Completed or ongoing long-term treatment with tranquilizer psychoactive drugs
- •Allergy treatment according to severity of symptoms with other than the following medication during the grass pollen season: Levocabastine nasal spray/eye drops, Loratadine/Cetirizin tablets, Salbutamol and exacerbation treatment with a short course of oral corticosteroids.
- •Contra-indication for adrenalin (for example, acute or chronic symptomatic coronary heart disease, severe hypertension)
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