EUCTR2010-022083-12-DE进行中（未招募）1 期
Evaluation of tolerability and efficacy of subcutaneous cluster-immunotherapy in patients with allergic rhinitis / rhino-conjunctivitis due to grass pollen - CLUSTOID® Tolerability and efficacy
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
- •Signed and dated patient's informed consent obtained prior to any study specific examination
- •Female or male patients aged 18–75 with allergic rhinitis and/or allergic rhinoconjunctivitis with or without seasonal controlled allergic asthma [The Global Strategy for Asthma Management and Prevention, Global Initiative for Asthma (GINA) 2010, http://www.ginasthma.org]
- •Clinically relevant allergy to grass pollen for at least 2 consecutive years
- •The sensitization to other aero-allergens and/or to mites, cats and dogs, has to be considered as not clinically relevant or that the allergic symptoms do not interfere with the study
- •Positive clinical history of grass pollen, verified by:
- •- positive screening skin prick test (SPT) against timothy pollen (wheal diameter =3 mm) and
- •- a clear negative result to the negative control (max. wheal diameter <2 mm) and
- •- a clear positive result to the histamine control (wheal diameter =3 mm) and
- •- presence of specific IgE against timothy pollen (positive CAP EAST class II and above) and
- •- a positive reaction after nasal provocation with a timothy allergen concentration of <=1,666 BU/mL and
- •- anti-allergic or anti-asthmatic treatment during the previous grass pollen season
- •An RRTSS during the previous pollen season of greater than or equal to nine
- •Compliance and ability of the patient to follow the instructions of the study stuff for the nasal provocation test (NPT)
- •Safety laboratory results within the normal range or out of normal range but considered as not clinically significant
- •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 87
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 5
排除标准
- •Previous immunotherapy with grass pollen extracts from the homologous group of grass and cereal pollen according to Annex 1 in the Guideline on allergen products: production and quality issues (EMEA/CHMP/BWP/304831/2007) within the last 5 years
- •Predominant perennial allergic rhinitis
- •Predominant perennial allergic asthma
- •Simultaneous participation in other clinical trials
- •Other reasons contra-indicating an inclusion into the trial according to the investigator's judgment (e.g. expected poor compliance)
- •Active tuberculosis
- •Patients with hypersensitivity to excipients of the investigational medicinal product
- •Any significant abnormal laboratory parameters or alteration in the vital signs that could increase the risk for the study patient
- •Diseases of the immune system including autoimmune and immune deficiencies
- •Immunosuppressive therapy
- •Severe chronic inflammatory diseases
- •Acute or chronic inflammatory or infectious airway diseases including recurrent acute or chronic sinusitis
- •Malignancy during the previous 5 years
- •Alcohol, drug, or medication abuse within the past year
- •Existing or intended pregnancy, lactation and/or lack of adequate contraceptive protection
- •Irreversible secondary disorders at the target organs (e.g. emphysema, bronchoectasis)
- •Systemic and local (eyedrops) treatment with beta-blockers
- •Use of tranquillizers or psychoactive drugs within 1 week prior to Visit 1
- •Use of systemic corticosteroids within 3 months prior to Visit 1
- •Immunization with vaccines within 7 days prior to Visit 1
- •Patients treated with other contra-indicated drugs (cf. section 11.2)
- •Partly controlled or uncontrolled asthma according to the Global Initiative for Asthma (GINA) Guideline, e.g. PEF or FEV1-value <80% of the predicted normal values calcula-ted by regression formulas (ERS EGKS 1993) according to: www.vitalograph.de/spirometry_normal_values_guidelines.php
- •Inflammation and infect of the target organs (e.g. nose, eyes, lung)
- •Contra-indication for adrenalin (for example, acute or chronic symptomatic coronary heart disease, severe hypertension, hyperthyroidism)
- •Completed or ongoing long-term treatment with tranquilizer or psycho active drugs
- •Completed or ongoing treatment with anti-IgE-antibody
- •Suspected inability to understand instructions/ study documents
- •Severe psychiatric, psychological, or neurological disorders
- •Patients being in any relationship or dependence with the Sponsor and/or investigator
- •Nursing (lactating) women or a positive pregnancy test at Visit 1
- •Patients who are not contractually capable
- •Persons who are jurisdictional or governmentally institutionalized
研究者
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