EUCTR2006-004222-93-DE进行中（未招募）不适用
Assessment of the Maximal Tolerated Dose of a Microencapsulated Grass (Phleum pratense) Pollen Extract (MGPE) in Subjects with Grass Pollen Allergy in a Randomized, Double-Blind, Placebo-Controlled Study - GPE 02
Curalogic A/S0 个研究点目标入组 30 人开始时间: 2006年9月27日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 30
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.Signed informed consent;
- •2.18 to 65 years old; both inclusive;
- •3.Have a history of two consecutive seasons of summer, seasonal allergic rhinitis from the end of May with a maximum during June and July that has required repeated treatment with antihistamines, leukotriene antagonists, nasal steroids, or topical cromones;
- •4.Have a positive skin prick test (SPT) to a standardized grass pollen extract (Phleum pratense) performed within the last six months before screening, which is defined as:
- •Diameter of the weal of at least the size of the positive control (histamine-dihydrochloride) and
- •Diameter of weal of at least 5 mm;
- •5.Have a grass-specific (Phleum pratense) IgE concentration of at least 0.7 kU/L using the Phadia ImmunoCAP assay (Freiburg, Germany);
- •6.Will be available for visits at the Clinical pharmacology research unit (CPRU) for the duration of the study;
- •7.Have a negative blood pregnancy test (women of childbearing potential). Women of childbearing potential, who are sexually active, must be consistently using a highly effective double method of contraception.
- •8.Are able to understand the study requirements and comply with study instructions.
- •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)
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1.Have a chronic or acute disease that, in the opinion of the Investigator, might interfere with the evaluation of the data for the IMP or might place the subject at additional risk;
- •2.Have a severe autoimmune disease or a severe immunodeficiency;
- •3.Have a neoplastic malignancy with present clinical relevance;
- •4.Have perennial or structurally related rhinitis, including vasomotor rhinitis, i.e., require treatment of the allergic symptoms with antihistamines or nasal steroids during the months of December and January;
- •5.Unable to comply with the study schedule and procedures;
- •6.Are currently receiving immunotherapy to any allergens or have received grass immunotherapy within three years before the Screening Visit (immunotherapy to other allergens than grass discontinued within 90 days before the Screening Visit is allowed);
- •7.Have moderate to severe persistent asthma (Global Initiative for Asthma, GINA, criteria III and IV) requiring daily controller medications (moderate to high doses of inhaled corticosteroids, long-acting bronchodilators, leukotriene antagonists) or use rescue medication (salbutamol for inhalation or similar short-acting bronchodilators) more than four times weekly at any time during the year;
- •8.Have insufficiently treated asthma and/or irreversible airway obstruction with a value of forced expiratory volume (FEV1) <70% of predicted (mean out of three acceptable values) despite of asthma medication
- •9.Repeated or daily use of proton pump inhibitors within one week before the Screening Visit and throughout the study;
- •10.Use prohibited medications or have inadequate washout periods before the start of the study. The following medications are prohibited during the study and if taken before the study, the required wash-out periods are indicated in brackets:
- •Oral corticosteroids (one month);
- •Antihistamines:
- •oH1-blocker (three days),
- •Anti-lgE medication (six months),
- •Tricyclic antidepressants (14 days);
- •11.Have significant chronic sinusitis as assessed by the Investigator;
- •12.Have Rhinitis medicamentosa from excessive use of nasal decongestants (e.g., oxymetazoline);
- •13.History of hypersensitivity to the IMP or its excipients (subjects enrolled in this study are expected to be allergic to grass). Hypersensitivity to the IMP means that the subject has had a previous systemic or severe local reaction to grass extract previously used for SPT or immunotherapy;
- •14.Are pregnant or lactating;
- •15.Participation in another study with any IMP in the three months before the study;
- •16.Treatment in the previous three months with any drug known to have a well-defined potential for toxicity to a major organ;
- •17.Blood or plasma donation of more than 500 mL during the month before the study and more than 50 mL within the two weeks before Day 1;
- •18.Positive test results for HIV1 and HIV2 virus, or for Hepatitis B surface-antigen (HBsAg ) or Hepatitis C virus antibody;
- •19.Current evidence of drug abuse or history of drug abuse within 18 months before the study, including history of alcohol abuse or active alcoholism;
- •20.Inability to understand the protocol requirements, instructions and study-related restrictions; the nature, scope, and possible consequences of the study;
- •21.Unlikely to comply with the protocol requirements, instructions and study-related restrictions; e.g., uncooperative attitude, inability to return for Follow-up Visits, and improbability of completing the study;
- •22.Subject is the Investi
研究者
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