Efficacy and safety of subcutaneous cluster immunotherapy with cluster-allergoid CLUSTOID® (glutaraldehyde-polymerized allergen extract of mixtures of grass and rye allergens – Holcus lanatus, Dactylis glomerata, Lolium perenne, Phleum pratense, Poa pratensis, Festuca elatior, Secale cereale) in patients with allergic rhinoconjunctivitis sensitized to grass and with or without rye pollen sensitization. A prospective, double-blind, randomized, placebo-controlled, multi-centre trial. - Specific Immunotherapy with CLUSTOID®: Efficacy and safety

ROXALL Medizin GmbH0 个研究点开始时间: 2008年4月30日最近更新: 2012年3月19日

适应症

试验速览

暂无简介。

•Patients aged 18–75 with allergic rhinitis and/or allergic rhinoconjunctivitis with or without seasonal mild or moderate allergic asthma (GINA I and GINA II).
•Positive clinical history of grass pollen.
•Clinical sensitization to grass with or without additional sensitization to rye pollen.
•Compliance and ability of the patient to complete a Diary Card
•Signed and dated patient´s informed consent form.
•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) yes
•F.1.3.1 Number of subjects for this age range

•Previous immunotherapy with grass or rye pollen extracts within the last 3 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 estimation (e.g. poor compliance),
•Active tuberculosis,
•Auto-immune disorders,
•Severe chronic-inflammatory diseases,
•Malignancy,
•Alcohol abuse,
•Existing or intended pregnancy, lactation and/or lack of adequate contraceptive protection,
•Irreversible secondary disorders at the target organ (e.g. emphysema, bronchoectasis),
•Patients treated with ?-blockers and/or other contra-indicated drug

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