NCT00783354已完成4 期
A Pilot, Multicenter, Double-blind Randomized Study for Comparison of Aerius® "Continuous Treatment" Versus Aerius® "PRN Regimen" on Chronic Idiopathic Urticaria Patient Quality of Life
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 129
- 主要终点
- Changes from Visit 2 to Visit 4 of Vq-derm questionnaire score and DLQI quality of life score.
研究概览
简要总结
This double-blind pilot study was conducted to establish the best way of using desloratadine treatment to protect quality of life of chronic idiopathic urticaria (CIU) patients, after an initial 4-weeks of daily treatment: prolonging systematic daily treatment or as needed (PRN; in the case of symptoms).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects must demonstrate their willingness to participate in the study and comply with its procedures by signing a written informed consent.
- •Subjects must be >= 18 years of age
- •Women of childbearing potential must have a negative urine pregnancy test at Visit 1 (Day 1) and must be using an acceptable method of birth control during the study.
- •Subjects must be in general good health; ie, they must be free of any clinically significant disease (other than CIU) that would interfere with study evaluations.
- •Subjects must understand and be able to adhere to visit schedules, and agree to complete the questionnaires and a diary.
- •Subjects must have at least a 6-week history of CIU (pruritus and hives) prior to Visit 1.
排除标准
- •Women who are pregnant or nursing.
- •Subjects who used any investigational drug in the last 30 days prior to Visit 1
- •Subjects with asthma requiring chronic use of inhaled or systemic corticosteroids.
- •Subjects who have been treated with any investigational antibodies for asthma or allergic rhinitis in the 90 days prior to Baseline.
- •Subjects who have been treated with intra-muscular or intra-articular corticosteroids in the 90 days prior to Baseline.
- •Subjects with urticaria that is primarily due to physical urticaria or other known etiology, except dermographism.
- •Subjects treated by immunosuppressive drugs.
- •Subjects who have been hospitalized (including an emergency department visit) because of deterioration in their CIU within 3 months prior to Visit
- •Subjects with a history of hypersensitivity to desloratadine or any of its excipients.
- •Subjects previously randomized into this study.
- •Subjects who have any clinically significant metabolic, cardiovascular, immunological, neurological, hematological, gastrointestinal, cerebrovascular, or respiratory disease, or any other disorder which, in the judgment of the investigator, may interfere with the study evaluations or affect subject safety.
- •Subjects with a history of psychosis, antagonistic personality, poor motivation, hypochondriasis, or any other emotional or intellectual problems that are likely to limit the validity of consent to participate in the study.
- •Subjects with a history of noncompliance with medications or treatment protocols.
研究组 & 干预措施
Continuous Treatment
Active Comparator
干预措施: desloratadine (Drug)
PRN regimen
Experimental
干预措施: desloratadine (Drug)
结局指标
主要结局
Changes from Visit 2 to Visit 4 of Vq-derm questionnaire score and DLQI quality of life score.
时间窗: 2 months
次要结局
- % of patients free of symptoms 2 months after Visit 4(2 months)
- Changes from Visit 2 of overall conditions of CIU(2 months)
- Average consumption of treatment between Visit 2 and Visit 5(4 months)
- Investigator's assessment of response to therapy(2 months)
- Estimation of disease free period after 3 months of daily treatment.(2 months)
- Average usage of rescue medication(2 months)
- Discontinuation due to treatment failure(2 months)
- Change from Visit 2 in pruritus symptom score assessed by the patient.(2 months)
- Quality of disease control(2 months)
研究者
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