A randomized double-blind multicentric prospective clinical trial to compare the efficacy, safety and tolerability of Fluticasone Nasal Spray BP (Mfd. By Biodeal Laboratories Pvt. Ltd.) Vs Fluticasone Nasal Spray BP (Mfd. By Glaxosmithkline Pharmaceuticals Ltd) in patients with Allergic Rhinitis
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 125
- 试验地点
- 2
- 主要终点
- Change in signs and symptoms (Clinical efficacy parameters) i.e. Sore Throat, Cough, Sneezing, Headache and Temperature at the end of Treatment.
研究概览
简要总结
The study is A prospective, comparative, randomized, double blind and multi centric trial to Evaluate the Efficacy, Safety and Tolerability of Fluticasone Nasal Spray BP (Mfd. by Biodeal Laboratories Pvt. Ltd.) Vs. Fluticasone Nasal Spray BP (Mfd. by GlaxoSmithkline Pharmaceuticals Ltd) in patients with Allergic Rhinitis for 14 days in 125 patients that will be conducted in two centers in India. The primary outcome measure will be Change in signs and symptoms (Clinical efficacy parameters) i.e. Sore Throat, Cough, Sneezing, Headache and Temperature at the end of Treatment.The secondary outcome measure will be Improvement in Global Assessment of efficacy and tolerability of treatment which will be judged by patients and physicians and to assess adverse events.
研究设计
- 分配方式
- Computer generated randomization
- 盲法
- Not Applicable
入排标准
入选标准
- •Availability of subjects for the entire study period and willingness to adhere to protocol requirements as evidenced by written informed consent.
- •Patient with history, signs & symptoms of Allergic Rhinitis.
排除标准
- •1.Patients < 18 & > 60 years2.History of hypersensitivity to the study drug or similar class of drug.3.Significant history or presence of gastrointestinal, liver or kidney disease, or any other conditions known to interfere with the absorption, distribution, metabolism or excretion of common medications.4.Pregnant or lactating women.5.Patients with serum creatinine greater than 2.5 mg/dl.6.Patients with raised SGPT and total bilirubin greater than 50% above the upper normal limits 7.Significant history or presence of glaucoma, cardiovascular or hematological disease.8.Any clinical significant illness during the 4 weeks prior to day 1 of this study.9.Maintenance therapy with any drug, or history of drug dependency, alcohol abuse, or serious neurological or psychological disease.10.Participation in a clinical trial with an investigation drug within 30 days proceeding day one of this study.11.Use of enzyme-modifying drugs within 30 days prior to day 1 of this study.12.HIV and Australian Antigen positive subjects.13.Any condition that, in the opinion of the investigator, does not justify the patient?s inclusion in the study.
结局指标
主要结局
Change in signs and symptoms (Clinical efficacy parameters) i.e. Sore Throat, Cough, Sneezing, Headache and Temperature at the end of Treatment.
时间窗: At Baseline, Day 7 and Day 14
次要结局
- Improvement in Global Assessment of efficacy and tolerability of treatment which will be judged by patients and physicians and to assess adverse events.(At Baseline, Day 7 and Day 14)