Phase 1 Study of AHIST in Seasonal Allergic Rhinitis Patients
试验速览
- 阶段
- 1 期
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- To gather pharmacodynamic measurements and assess blood levels (five draws) of the active ingredient in AHIST over the dosage interval period of 12 hours.
研究概览
简要总结
Objectives:
A) To gather pharmacodynamic measurements and assess blood levels of the active ingredients in AHIST over the dosage interval period of 12 hours.
Hypothesis: Hysteresis curves plotting each active ingredient's blood levels over a 12-hour dosage interval will substantiate S5 Symptom Diary scores (IE: evidentiary therapeutic window data);
B) To report subjective scores by subjects rating the efficacy of a single dose AHIST in relieving nasal congestion, rhinorrhea, nasal itching, sneezing, and post-nasal drip over a 12-hour dosage interval.
Hypothesis: Greater than 66% of subjects will document clinically significant relief over a 12-hour period from one dose of AHIST;
C) Report any side effects or adverse drug reactions and rate the severity of any incidence.
Hypothesis: Not more than one patient will have an adverse event significant enough to warrant withdrawal; side effects will be mild with the most frequently reported side effect occurring in less than 10% of patients-drowsiness.
详细描述
This Phase 1 clinical trial will be a single dose pharmacokinetics study comprised of 21 individuals with five blood draws over a 12 hour period. Additionally, subjects will subjectively score symptom relief and report any side effects from the single dose of AHIST. Schulman Associates Institutional Review Board (Cincinnati, OH) will approve the study protocol and statement of informed consent. Each study participant will give written informed consent (See Attachment A). Safety will be assured through close observation and physical examination of subjects before, during and at study conclusion. This interventional study will be conducted during the spring allergy season of 2010.
MAGNA plans to show that chlorpheniramine tannate is a safe and effective B.I.D. drug treatment regimen, "indicated for the relief of symptoms associated with seasonal allergic rhinitis in adults and children 12 years of age and older. Treated symptoms include nasal congestion, sneezing, rhinorrhea, itchy nose, itchy/watery eyes, and post nasal drip syndrome [reduction in tickly cough (acute or chronic), mucus in the back of the throat, sore throat, and hoarseness]."
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Male and females of any ethnic group between 18 and 60 years of age.
- •History of moderate to severe Seasonal Allergic Rhinitis (SAR) for at least two years.
- •Subjects' symptoms resulting from the irritation of sinus, nasal and upper respiratory tract tissues will include the five symptoms ("S5") that are the focus of this study: nasal congestion, rhinorrhea, nasal itching, sneezing, and post nasal drip.
- •Prior to study drug administration, subjects' good health will be confirmed by medical history, physical examination, and urine dip pregnancy test.
- •Allergic hypersensitivity will be confirmed by an appropriate test as deemed necessary by the physician or well established patient medical history.
排除标准
- •Pregnancy or lactation.
- •Immunotherapy unless at stable maintenance dose.
- •Presence of a medical condition that might interfere with treatment evaluation or require a change in therapy including but not limited to high blood pressure or urinary retention problems.
- •Alcohol dependence.
- •Use of any other investigational drug in the previous month.
- •Subjects presenting with asthma requiring corticosteroid treatment.
- •Subjects with multiple drug allergies.
- •Subjects known to have an idiosyncratic reaction to any of the ingredients in AHIST.
研究组 & 干预措施
AHIST for seasonal allergic rhinitis
AHIST for SAR: each green tablet contains 12mg chlorpheniramine tannate.
干预措施: AHIST NDC#58407-012-01 (Drug)
结局指标
主要结局
To gather pharmacodynamic measurements and assess blood levels (five draws) of the active ingredient in AHIST over the dosage interval period of 12 hours.
时间窗: April 2011
次要结局
- To report any side effects or adverse drug reactions and rate the severity of incidence.(April 2011)