A Study to Evaluate the Safety and Tolerability of a Nasal Spray to Treat Perennial Allergic Rhinitis
2015年5月4日 更新者:Meda Pharmaceuticals
Active Controlled Trial of the Safety and Tolerability of MP 03-036 (Astepro 0.15%) in Patients With Perennial Allergic Rhinitis
The purpose of this study is to determine if one allergy treatment (0.15% azelastine hydrochloride) is as safe as mometasone furoate (nasonex) alone.
研究概览
研究类型
介入性
注册 (实际的)
703
阶段
- 第三阶段
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
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Alabama
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Oxford、Alabama、美国、36203
- Center of Research Excellence, LLC
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California
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Fountain Valley、California、美国、92708
- AABI Associates Medical Group
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Huntington Beach、California、美国、92647
- Allergy and Asthma Specialist Medical Group
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Long Beach、California、美国、90806
- West Coast Clinical Trials
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Los Angeles、California、美国、90025
- Allergy Research Foundation
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Mission Viejo、California、美国、92691
- Southern California Research
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San Diego、California、美国、92120
- Allergy Associates Medical Group Inc
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San Diego、California、美国、92123
- Allergy and Asthma Medical Group and Research Center
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San Jose、California、美国、95117
- Allergy & Asthma Associates of Santa Clara Valley Research Cntr
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Stockton、California、美国、95207
- Bensch Research Associates
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Walnut Creek、California、美国、94598
- Allergy and Asthma Clinical Research, Inc.
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Colorado
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Colorado Springs、Colorado、美国、80907
- Asthma and Allergy Associates
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Florida
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Ocala、Florida、美国、34471
- Allergy and Asthma Care of Florida
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Tallahassee、Florida、美国、32308
- Allergy and Asthma DTC
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Georgia
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Albany、Georgia、美国、31707
- Georgia Pollens Clinical Research Centers Inc
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Savannah、Georgia、美国、31406
- Aeroallergy Research Laboratories of Savannah
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Stockbridge、Georgia、美国、30281
- Clinical Research Atlanta
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Illinois
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Normal、Illinois、美国、61761
- Sneeze, Wheeze and Itch Associates
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Kansas
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Overland Park、Kansas、美国、66210
- Kansas City Allergy and Asthma
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Louisiana
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Metairie、Louisiana、美国、70001
- RX R+D
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Maryland
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Wheaton、Maryland、美国、20902
- Institute for Asthma and Allergy PC
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Massachusetts
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North Dartmouth、Massachusetts、美国、02747
- Northeast Medical Research Associates
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Minnesota
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Minneapolis、Minnesota、美国、55402
- Clinical Research Institute
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Plymouth、Minnesota、美国、55441
- Clinical Research Institute
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Missouri
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St. Louis、Missouri、美国、63141
- The Clinical Research Center
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Nebraska
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Papillion、Nebraska、美国、68046
- The Asthma and Allergy Center
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Nevada
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Henderson、Nevada、美国、89052
- Las Vegas Physicians Research Group
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New Jersey
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Mount Laurel、New Jersey、美国、08054
- Allergy and Asthma Research NJ inc
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Ocean、New Jersey、美国、07712
- Atlantic Research Center
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Teaneck、New Jersey、美国、07666
- Dr. Perin
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New York
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North Syracuse、New York、美国、13212
- Medical Research Associates of CNY, PLLC
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Rochester、New York、美国、14618
- AAIR Research Center
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North Carolina
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Raleigh、North Carolina、美国、27612
- Wake Research Associates, LLC
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Raleigh、North Carolina、美国、27607
- North Carolina Clinical Research
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Ohio
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Cincinnati、Ohio、美国、45231
- Bernstein Clinical Research Center
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Cincinnati、Ohio、美国、45252
- New Horizon's Clinical Research
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Oklahoma
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Edmond、Oklahoma、美国、73003
- Oklahoma Institute of Allergy and Asthma Clinical
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Oklahoma City、Oklahoma、美国、73120
- Allergy, Asthma and Clinical Research Center
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Oregon
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Lake Oswego、Oregon、美国、97035
- Allergy Asthma and Dermatology Research
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Medford、Oregon、美国、97504
- Clinical Research Institute of Southern Oregon, PC
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Pennsylvania
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Blue Bell、Pennsylvania、美国、19422
- Allergy and Asthma Specialist PC
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Collegeville、Pennsylvania、美国、19426
- Allergy and Consultants of NJ/PA
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Pittsburgh、Pennsylvania、美国、15241
- Allergy and Clinical Immunology Associates
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Upland、Pennsylvania、美国、19013
- Asthma and Allergy Research Associate
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Rhode Island
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Providence、Rhode Island、美国、02906
- Asthma, Nasal Disease & Allergy Research Center of New England
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South Carolina
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Charleston、South Carolina、美国、29407
- National Allergy, Asthma and Urticaria of Charleston
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Texas
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Austin、Texas、美国、78731
- Allergy and Asthma Associates
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Dallas、Texas、美国、75231
- AARA Research Center
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Dallas、Texas、美国、75231
- Pharmaceutical Research & Consulting Inc
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El Paso、Texas、美国、79902
- Western Sky Medical Research
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Houston、Texas、美国、77074
- SWAAA Research Center
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New Braunfels、Texas、美国、78130
- Central Texas Health Research
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San Antonio、Texas、美国、78229
- Biogenics Research Institute
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San Antonio、Texas、美国、78229
- Sylvana Research Associates
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San Antonio、Texas、美国、78233
- Live Oak Allergy and Asthma Clinic
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Waco、Texas、美国、76712
- Allergy Asthma Research Institute
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Virginia
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Richmond、Virginia、美国、23229
- VA Adult and Pediatric Allergy and Asthma
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Washington
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Seattle、Washington、美国、98105
- ASTHMA, Inc.
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Wisconsin
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Milwaukee、Wisconsin、美国、53209
- Advanced Healthcare
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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
12年 及以上 (孩子、成人、年长者)
接受健康志愿者
不
有资格学习的性别
全部
描述
Inclusion Criteria:
- Male and female patients 12 years and older with a compatible history greater than or equal to 1 year of rhinitis due to perennial allergies.
- Must be willing and able to provide informed consent and to participate in all study procedures
- Must be in generally good health
- Positive skin test to a prevalent perennial allergen
Exclusion Criteria:
- On nasal examination, the presence of nasal mucosal erosion, nasal ulceration or nasal septal perforation
- Use of any investigational drug within 30 days of the first visit
- Any nasal surgery or sinus surgery within the previous year
- Presence of any hypersensitivity to drugs similar to azelastine or mometasone furoate and to either sorbital or sucralose
- Women who are pregnant or nursing
- Women who are not using an acceptable method of birth control
- Nasal Diseases likely to affect deposition of intranasal medication, such as sinusitis, rhinitis medicamentosa or clinically significant nasal polyposis or nasal structural abnormalities.
- Asthma or other lung diseases such as COPD. Mild asthma symptoms may be considered after consultation with investigator.
- Patients with Arrythmia
- Patients with know history of alcohol and drug abuse
- Existence of any surgical or medical condition, which in the opinion of the investigator or sponsor, might significantly alter the evaluation of the study.
- Use of medications that could affect the study results
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:无(打开标签)
武器和干预
参与者组/臂 |
干预/治疗 |
---|---|
实验性的:1
0.15% azelastine hydrochloride 1644 mcg
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1644 mcg (205.5 mcg/spray) 2 sprays per nostril twice a day/AM and PM
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实验性的:2
Mometasone furoate 200 mcg
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200 mcg (50 mcg/spray) 2 sprays per nostril Once a day (AM)
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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 |
---|---|---|
Change From Baseline on Direct Visual Nasal Exams to 12 Months
大体时间:Change from baseline to 12 months
|
Examination of head and neck (scale: None, Mild, Moderate, Severe) for Epistaxis, Mucosal Edema, Nasal Discharge, Mucosal erythema, Mucosal Bleeding, and Crusting of mucosa.
Nasal irritation was rated: 0 = None, Grade 1A = focal irritation, Grade 1B = superficial mucosal erosion, Grade 2 = moderate mucosal erosion, Grade 3 = ulceration, Grade 4 = septal perforation
|
Change from baseline to 12 months
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其他结果措施
结果测量 |
措施说明 |
大体时间 |
---|---|---|
Change From Baseline to 12 Months in the Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) Compared to Placebo in Subjects 18 Years of Age and Older
大体时间:change from baseline to 12 months
|
A 28-item RQLQ was completed on Day 1, Month 1, Month 3, Month 6, month 9 and month 12 or Early termination. The RQLQ consists of 7 domains rated on a 7 point scale with 0 being not troubled by the allergy symptoms, and 6 being extremely troubled/all of the time. Domain score will be calculated from the mean score of all items in the domain. Overall score will be calculated from the mean score of all items. |
change from baseline to 12 months
|
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。
调查人员
- 研究主任:Lewis M. Fredane, MD、Meda Pharmaceuticals
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
2007年3月1日
初级完成 (实际的)
2008年6月1日
研究完成 (实际的)
2008年7月1日
研究注册日期
首次提交
2008年7月21日
首先提交符合 QC 标准的
2008年7月21日
首次发布 (估计)
2008年7月22日
研究记录更新
最后更新发布 (估计)
2015年5月21日
上次提交的符合 QC 标准的更新
2015年5月4日
最后验证
2015年5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.
0.15% azelastine hydrochloride的临床试验
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M.D. Anderson Cancer Center撤销转移性肺非小细胞癌 | IVA 期肺癌 AJCC v8 | IVB 期肺癌 AJCC v8 | IV 期肺癌 AJCC v8
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Arcutis Biotherapeutics, Inc.完全的
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University of ManchesterMedical Research Council; JP Moulton Charitable Foundation完全的