EUCTR2010-021858-20-DE进行中（未招募）不适用
DOUBLE BLIND RANDOMISED, PLACEBO AND ACTIVE CONTROLLED, PROOF OF ACTIVITY STUDY OF UR-63325 IN ALLERGIC RHINITIS INDUCED BY NASAL CHALLENGE TO ALLERGIC PATIENTS OTHERWISE HEALTHY.
PALAU PHARMA, S.A.0 个研究点目标入组 24 人开始时间: 2010年8月23日最近更新:
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 24
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
- Male
入选标准
- •1. Caucasian males between the ages of 18 and 55
- •2. No clinically relevant abnormal physical findings at the screening examination
- •3. No clinically relevant abnormal ECG at the screening examination
- •4. No clinically relevant abnormal resting blood pressure (systolic: 90-140 mmHg; diastolic: 50-90 mmHg) and resting heart rate (50-100 bpm)
- •5. Body Mass Index of 19.0-29.9 (kg/m2)
- •6. Ability to communicate well with the investigator and to comply with the requirements of the entire study.
- •7. Availability for daily telephonic follow-up and willingness to provide contact details to be located at any time during the treatment days.
- •8. Provision of written informed consent to participate (prior to any study-related procedures being performed) as shown by a signature on the volunteer consent form and to be able to adhere to the study restrictions and examination schedule
- •9. Subjects with history of seasonal allergic rhinitis to grass within the previous two years
- •10. Positive skin prick test to timothy grass pollen (wheal difference with negative control = 3 mm) at screening
- •11. Subjects with positive response to screening nasal challenge with increasing doses of timothy grass pollen (symptoms worsening (TNSS=4-6) within one hour after last nasal allergen challenge)
- •12. Baseline FEV1 80% predicted and baseline FEV1/FVC 70% predicted
- •13. In case of sexually active men who have not been sterilized surgically, use of a double contraception method during intercourse to prevent a pregnancy from possibly damaged sperm:
- •-intrauterine device (IUD) or hormonal contraception plus condom or diaphragm or spermicide, or
- •-condom plus diaphragm, or
- •-abstinence during the clinical study until the Follow-up visit
- •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
- •1. Symptoms of allergic rhinitis within 2 weeks prior to screening
- •2. Upper respiratory infection or sinusitis within 14 days of screening and also within 14 days of study start in each of the two periods
- •3. Structural nasal abnormalities or nasal polyps on examination, a history of nose bleeding or recent nasal surgery
- •4. History of asthma or asthmatic symptoms or other respiratory disease other than rhinitis within the last 2 years or FEV1<80% of predicted at screening or baseline
- •5. Contraindication to nasal corticosteroids
- •6. Administration of any investigational drug in the period of 3 months before first entry to the study. Participation in any other investigational study
- •7. Subjects who have taken any prescribed or over the counter drug (including antacid drugs and herbals), with the exception of paracetamol (up to 3 g per day) within 4 weeks prior to the screening or at least 10 half lives of the administered drug
- •8. History of immunotherapy in the past 3 years or currently on an immunotherapy treatment course
- •9. Subjects who have taken inhaled or local (nasal or inhaled) corticosteroids within 4 weeks prior to the screening
- •10.Subjects who have undergone major surgery or have donated or lost more than 500 mL of blood within 8 weeks before entry to the study
- •11.History of serious adverse reaction or hypersensitivity to any drug
- •12.Subjects who have previous history of neurological disease, including previous epilepsy or neuromuscular diseases, or who have had previous clinically significant psychiatric disease, including depression, schizophrenia or anxiety disorders
- •13.Inability to communicate or co-operate with the investigator because of a language problem, poor mental development or impaired cerebral function
- •14.Unwillingness to be easily located at any time during the 7 days of treatment and in general during the study.
- •15.Smoker of > 5 cigarettes per day or unwilling to stop smoking for the duration of study (screening to end of follow-up)
- •16.Drinker of more than 5 cups daily of beverage containing caffeine
- •17.Daily alcohol intake bigger than 3 units per day (one unit=8 g or about 10 mL of pure alcohol) or unwilling to stop alcohol intake for the duration of the study (screening to end of follow-up)
- •18.History of drug dependence other than tobacco within the past 2 years
- •19.Positive urine drug screen for drugs
- •20.Subjects with any clinically significant abnormality following review of pre-study laboratory tests or on direct questioning and physical examination, including known or suspected HIV, HBV and HCV infection
- •21.Subjects with sucrose intolerance
- •22.Subjects who forfeit their freedom by administrative or legal award or who are under guardianship
- •23.Subjects who are unwilling to give their informed consent
- •24.Any other condition which, in the opinion of the investigators, is likely to interfere with the successful collection of the measures required for the study
研究者
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