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 Ltd0 个研究点目标入组 560 人开始时间: 待定最近更新:
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 560
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •1. Patients age >=12 and <= 65 years inclusive of either sex.
- •2. 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.
- •3. Patient with a documented clinical history of Seasonal Allergic Rhinitis with exacerbations during the study season and/or exhibiting a positive skin prick test
- •4. 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
- •1. Pregnant or lactating women.
- •2. Patients with known hypersensitivity to any of the components of the formulation.
- •3. Patients with a history of anaphylaxis and/or other severe local reaction(s) to skin testing
- •4. Patients with alcohol or drug dependence.
- •5. Patients with perennial rhinitis with little or no seasonal exacerbations; non-allergic rhinitis or ocular infection within 3 weeks before the screening.
- •6. Patients with documented evidence of acute or significant chronic sinusitis or chronic purulent postnasal drip or Rhinitis Medicamentosa as determined by the investigator.
- •7. Patients with a history of psychiatric illness.
- •8. 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.
- •9. 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.
- •10. 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.
- •11. Patients with current evidence of clinically significant hematopoietic, cardiovascular, hepatic renal, neurologic, psychiatric, autoimmune disease, or other disease that precludes the subjectâ??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 subjectâ??s ability to complete or reliably complete the patientâ??s diary.
- •12. Patients who have participated in any clinical trial in the past 1 month
研究者
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