Efficacy Study of a Preseasonal Treatment With AllerT in Subjects With Birch Pollen Allergy
2015年3月30日 更新者：Anergis
Phase IIb Study to Assess the Efficacy, Safety and Tolerability of Two Dosing Regimens of AllerT in Comparison to Placebo in Adult Subjects Allergic to Birch Pollen
The main objective of the trial is to demonstrate the efficacy of a two months pre-seasonal treatment with AllerT 100 µg maintenance dose in reducing symptoms of allergic rhinoconjunctivitis during the following birch pollen season
研究概览
研究类型
介入性
注册 (实际的)
240
阶段
- 阶段2
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习地点
-
-
-
Arhus、丹麦、8000
- Lungemedicinsk Forskningsafdeling
-
Odense、丹麦、5000
- Klinisk Institute
-
-
Copenhagen
-
Hellerup、Copenhagen、丹麦、2900
- Allergiklinikken
-
-
-
-
-
Rezekne、拉脱维亚、4601
- Viktorija Vevere private practice of Allergology
-
Riga、拉脱维亚、1003
- Center of examination and treatment of allergic diseases
-
Riga、拉脱维亚、1002
- Paul Stradins Clinical University Hospital - Pulmonology Allergology
-
-
-
-
-
Reims、法国、51092
- CHU de Reims
-
Strasbourg、法国、67000
- Hopitaux Universitaires de Strasbourg
-
-
-
-
-
Lodz、波兰、90153
- SPZOZ Uniwersytecki Szpital Kliniczny - Allergology
-
Lodz、波兰、90553
- Alergologii Centrum
-
Lublin、波兰、20095
- Alergotest
-
Tarnow、波兰、33100
- Alergo-Med
-
Warszawa、波兰、01157
- Centrum Alergologii IRMED
-
Wroclaw、波兰、50-368
- Silesian Piasts University of Medicine in Wrocław
-
Wroclaw、波兰、54203
- Aler-med
-
Zabrze、波兰、41800
- NZOZ Przychodnia Lekarska Hipokrates
-
-
-
-
-
Lund、瑞典、22185
- University hospital Skane
-
Orebro、瑞典、70185
- Örebro University Hospital
-
Vasteras、瑞典、72189
- Lungavdelningen, Vastmanlands
-
-
-
-
VD
-
Lausanne、VD、瑞士、1005
- Centre Hospitalier Universitaire Vaudois
-
-
-
-
-
Kaunas、立陶宛、50009
- Kaunas Clinics University Hospital
-
Vilnius、立陶宛、08661
- Vilnius University Hospital
-
Vilnius、立陶宛、08431
- Allergy Clinic JSC Perspektyvos
-
Vilnius、立陶宛、10200
- Antakalnio affiliation of the Vilnius City Allergy Center
-
-
参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
18年 至 55年 (成人)
接受健康志愿者
不
有资格学习的性别
全部
描述
Inclusion Criteria:
moderate to severe allergic rhinoconjunctivitis to birch pollen:
- Score of symptoms of the Rhinoconjunctivitis Symptom Score (RSS) ≥ 12 during the two preceding birch pollen seasons
- Previous use of anti-allergy medications during the two preceding birch pollen seasons
- Positive SPT to birch pollen extract
- Positive specific IgE CAP test for Bet v 1
Exclusion Criteria:
- uncontrolled asthma, FEV1 < 80% of predicted
- previous SIT (specific immunotherapy) to birch pollen or any other SIT within 5 years
- clinical symptoms due to allergens other than birch pollen during the whole trial period
- history of anaphylaxis
- positive skin prick test to AllerT
- any other treatment or conditions which may increase the risk of the study for the subject or affect the efficacy assessments during the birch pollen season
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：四人间
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
安慰剂比较：placebo
SC injections of placebo
|
SC injections of placebo on days 1, 7, 14, 28 and 56
|
|
实验性的：AllerT low dose
SC injections of AllerT 25 or 50 micrograms
|
SC injections of AllerT 25-50 micrograms on days 1, 7, 14, 28 and 56
其他名称：
|
|
实验性的：AllerT full dose
SC injections of AllerT 50-100 micrograms
|
SC injections of AllerT 50-100 micrograms on days 1, 7, 14, 28 and 56
其他名称：
|
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Combined Rhinoconjunctivitis Symptom and Medication Score
大体时间：up to 6 weeks during the birch pollen season 2013
|
The efficacy analysis will be performed on the symptom and medication data collected from the first day of the birch pollen season as defined by pollen counts in the air in each site region (from March to May 2013 depending on site region), to 42 days later or to the end of the pollen season, whichever comes first. The scale range is from 0 to 3. Lower is the the RSMS value, better is the efficacy as this implies that lower is the symptoms and concomitant medication intake by the patient The RSMS includes 2 subscales : the Rhinoconjunctivitis Symptom Score (RSS) with a range of values from 0 to 3 and the Rhinoconjunctivitis Medication Score Score (RMS) with also a range of values from 0 to 3 The RSMS is the sum of the RSS and RMS divided by 2 |
up to 6 weeks during the birch pollen season 2013
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Quality of Life
大体时间：up to 6 weeks during the birch pollen season 2013
|
mini-RQLQ questionnaires
|
up to 6 weeks during the birch pollen season 2013
|
|
Safety and Tolerability
大体时间：from start of treatment to 28 days after completion of treatment, i.e. for approximately 12 weeks
|
Adverse events will be collected throughout the trial period and will be reported as Treatment emergent adverse events occurring between start of treatment and 28 days after completion of treatment for each subject
|
from start of treatment to 28 days after completion of treatment, i.e. for approximately 12 weeks
|
其他结果措施
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Immunological Markers: Specific IgE and IgG4
大体时间：before treatment, 4 weeks after the last injection and 2 weeks before, at the peak time and within 2 weeks after the end of the expected birch pollen season 2013
|
blood samples will be drawn at the above time points to measure immunological markers: specific IgE and IgG4
|
before treatment, 4 weeks after the last injection and 2 weeks before, at the peak time and within 2 weeks after the end of the expected birch pollen season 2013
|
合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
赞助
调查人员
- 首席研究员：Francois Spertini, MD、Centre Hospitalier Universitaire Vaudois
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始
2012年10月1日
初级完成 (实际的)
2013年9月1日
研究完成 (实际的)
2013年9月1日
研究注册日期
首次提交
2012年10月29日
首先提交符合 QC 标准的
2012年10月31日
首次发布 (估计)
2012年11月2日
研究记录更新
最后更新发布 (估计)
2015年4月13日
上次提交的符合 QC 标准的更新
2015年3月30日
最后验证
2015年3月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.