CTRI/2013/01/003334已完成3 期
A Multicenter, Open-Label, Randomized, Parallel-Group, Comparative Study To Evaluate Efficacy, Safety and Tolerability of Fixed Dose Combination of Azelastine and Mometasone Nasal Spray Compared to Azelastine Nasal Spray and Mometasone Nasal Spray in Patients with Seasonal Allergic Rhinitis
Glenmark Pharmaceuticals Ltd37 个研究点 分布在 1 个国家目标入组 560 人开始时间: 2013年1月31日最近更新:
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 560
- 试验地点
- 37
- 主要终点
- Mean change in Total Nasal Symptoms Score from Baseline to End of treatment.
研究概览
简要总结
This is open label, randomized, active controlled, parallel-group, comparative study. Study will enroll 560 patients with seasonal allergic rhinitis from different centers from India. xml:namespace prefix = o ns = "urn:schemas-microsoft-com:office:office" /
Patients will be recruited after providing written informed consent. After screening, patients will be randomized (meeting randomization criteria) in equal ratios to receive either of the products for two weeks. The primary objective of the study is to see the mean change in total nasal symptom score at the end of treatment. Secondary objective includes mean change in nasal and non-nasal symptom score and mean change in RQOL at 2 weeks.
During the study, there will be 5 study visits for efficacy, safety and tolerability assessment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Open Label
入排标准
- 年龄范围
- 12.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •Patients age ≥12 and ≤ 65 years inclusive of either sex.
- •The combined score of nasal symptoms (nasal congestion, rhinorrhea, nasal itching and sneezing) must be at least 6; and nasal congestion severity score must be at least 2 at screening.
- •Patient with a documented clinical history of Seasonal Allergic Rhinitis with exacerbations during the study season and/or exhibiting a positive skin prick test
- •Patient with ability to understand and sign written informed consent form, which must have been obtained prior to screening.
- •Subjects under the legal age of consent must have provided assent and have had the written informed consent of the parent or guardian.
排除标准
- •Pregnant or lactating women.
- •Patients with known hypersensitivity to any of the components of the formulation.
- •Patients with a history of anaphylaxis and/or other severe local reaction(s) to skin testing
- •Patients with alcohol or drug dependence.
- •Patients with perennial rhinitis with little or no seasonal exacerbations; non-allergic rhinitis or ocular infection within 3 weeks before the screening.
- •Patients with documented evidence of acute or significant chronic sinusitis or chronic purulent postnasal drip or Rhinitis Medicamentosa as determined by the investigator.
- •Patients with a history of psychiatric illness.
- •Patients with nasal structure abnormalities, including nasal ulceration, nasal mucosal erosion, large nasal polyps and marked septal deviations that significantly interfere with nasal air flow.
- •Patients with an active pulmonary disorder, upper respiratory tract or sinus infection that required antibiotic therapy at least 14 day prior to the Screening Visit or a viral upper respiratory infection within 7 days before the Screening Visit.
- •Patients with history of narrow-angle glaucoma, increased intraocular pressure, posterior subcapsular cataract, urinary retention, hypertension, severe Coronary Artery Disease, Ischemic Heart Disease, Diabetes Mellitus, Hyperthyroidism, Renal Impairment or Prostatic Hypertrophy, and those receiving monoamine oxidase (MAO) inhibitor therapy.
- •Patients with current evidence of clinically significant hematopoietic, cardiovascular, hepatic renal, neurologic, psychiatric, autoimmune disease, or other disease that precludes the subject’s participation in the study.
- •Particular attention should be given to exclude subjects with conditions that would currently interfere with the absorption, distribution, metabolism or excretion of the study drug or interfere with the subject’s ability to complete or reliably complete the patient’s diary.
- •Patients who have participated in any clinical trial in the past 1 month.
结局指标
主要结局
Mean change in Total Nasal Symptoms Score from Baseline to End of treatment.
时间窗: Time Point: 14 days (two weeks).
次要结局
- Mean change in individual symptom scores from Baseline to End of treatment.(Time Point: 14 days (two weeks).)
- Patients Self Evaluation for overall Response to Treatment at the End of treatment.(Time point: 14 days (two weeks).)
- Mean change in Rhinoconjunctivitis Quality-of-Life Score (RQOL) from Baseline to End of treatment.(Time point: 14 days (two weeks).)
研究者
研究点 (37)
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