EUCTR2009-014036-37-ES进行中（未招募）1 期
Estudio multicéntrico, aleatorizado, controlado con placebo y doble ciego para evaluar la seguridad y la eficacia de una inmunoterapia específica con una preparación alergoide de ácaros del polvo Dermatophagoides pteronyssinus adsorbida en hidróxido de aluminio en pacientes con rinitis/rinoconjuntivitis con o sin asma bronquial alérgica.
Allergopharma Joachim Ganzer KG0 个研究点目标入组 0 人开始时间: 2010年5月13日最近更新:
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
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 subject 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 subject.)
- •2. Is the subject a legally competent male or female outpatient?
- •3. Is the subject aged 12 - 60 years?
- •4. Does the subject suffer from IgE-mediated seasonal allergic rhinitis/rhinoconjunctivitis with or without asthma (controlled, acc. to Global Initiative for Asthma [GINA] 2006) documented by:
- •o SPT wheal for D. pter. ?5 mm in diameter and
- •o Histamine (1% histamine) wheal ?3 mm and
- •o NaCl control reaction <3 mm and
- •o EAST result ?1.5 kU/L to D. pter. (central laboratory) and
- •o Main discomfort in the months October to December or over the entire year on exposure to house dust mites and
- •o Treated with anti-allergic medications for at least 2 years before enrolment.
- •At the Beginning of the Treatment Period (March 2011):
- •5. Does the subject have proven exposure to house dust mites demonstrated by positive house dust mite allergen determination in bed/upholstered furniture of the subject?s living area?
- •6. Has the subject demonstrated adequate symptoms in the subject diary?
- •Are the trial subjects under 18? yes
- •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
- •- Is the subject unable to understand and comply with the requirements of the trial?
- •- Does the subject show a total IgE of >2000 kU/l?
- •- Is the subject currently participating in any other trial or has the subject participated in any other trial within 30 days before inclusion in this trial?
- •- Is/was the subject involved in the planning and conduct of the trial, an employee of Allergopharma Joachim Ganzer KG or of one of the trial sites or in any relationship of dependence with the sponsor and/or with the investigator?
- •- Has the subject been previously enrolled or randomised to treatment in the present trial?
- •- Is the subject mentally disabled or institutionalised due to an official or judicial order?
- •- Does the subject have a positive pregnancy test before the baseline period?
- •- Does the subject use an unacceptable and unreliable contraceptive method during the trial, is pregnant or within the lactation period or is seeking to become pregnant?
- •- Has the subject undergone previous specific immunotherapy with allergens of house dust or storage mites in any formulation?
- •- Is the subject currently undergoing any sort of immunotherapy?
- •- Has the subject ever undergone specific immunotherapy with unknown allergen or an unsuccessful immunotherapy?
- •- Has the subject undergone changes in sanitation actions against house dust mites in the previous 12 months before trial entry or planning changes during the trial?
- •- Has the subject for storage mites like Acarus siro, Lepidoglyphus destructor or Tyrophagus putrescentiae:
- •o Clinically relevant symptoms or
- •o Sensitisation in the SPT: wheal diameter of respective interfering allergen ? wheal diameter of D. pter. or
- •o Sensitisation to respective interfering allergen as determined by serum immunoassay ? kU/L value of D. pter.
- •- Has the subject for other allergens than D. pter. that interfere with the annual diary periods from October to December:
- •o Clinically relevant symptoms or
- •o Sensitisation in the SPT: wheal diameter of respective interfering allergen ?3 mm or
- •o Sensitisation to respective interfering allergen as determined by serum immunoassay >1.5 kU/L.
- •Such other interfering allergens are especially of:
- •? Cat or dog,
- •? Moulds like Aspergillus or Penicillium,
- •? Blatella germanica,
- •? Parietaria and cypress family (only Spain and Italy)
- •- Does the subject suffer from clinically relevant rhino-conjunctival or respiratory symptoms related to other reasons?
- •- Has the subject a peak expiratory flow (PEF) or FEV1 <80% of predicted normal?
- •- Has the subject uncontrolled or partly controlled asthma according to GINA guidelines?
- •- Has the subject suffered from asthma for more than 10 years?
- •- Has the subject suffered from rhinitis/rhinoconjunctival atopy symptoms for 20 years or longer?
- •- Does the subject suffer from severe acute or chronic diseases, severe inflammatory diseases?
- •- Does the subject suffer from autoimmune diseases, immune-defects including immune-suppression, immune-complex-induced immunopathies?
- •- Does the subject suffer from severe psychiatric and psychological disorders including impairment of cooperation?
- •- Does the subject suffer from recurrent seizures?
- •- Does the subject suffer from irreversible secondary alterations of the reactive organ?
- •- Has the subject any physiological and laboratory variables within/outside normal limits and reported to be greater than Grade 1 changes according to the Food and Drug Administration (FDA) Guidance for In
研究者
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