CTRI/2020/10/028347进行中（未招募）3 期
A prospective, randomized, comparative,double blind, two-arm, active-controlled,parallel, multicentre phase III clinical trial toassess the efficacy and safety of FluticasoneFuroate and Oxymetazoline HydrochlorideNasal Spray 27.5 / 50 mcg as compared toFluticasone Furoate Nasal Spray 27.5mcg inpatients with allergic rhinitis
试验速览
- 阶段
- 3 期
- 状态
- 进行中（未招募）
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 of either sex 18 to 65 years of age (both inclusive)
- •2. Patient with a documented clinical history of Seasonal Allergic Rhinitis with exacerbations during the study season
- •3. Patients with Total Nasal Symptom Score >=6 and nasal congestion score greater than or equal to 2
- •4. Patients willing to provide written informed consent and comply with the
- •protocol requirements
- •5. Patients literate enough to fill the diary card
排除标准
- •1. Patients with known hypersensitivity to Oxymetazoline, Fluticasone and / or any other drug of same class
- •2. Patients with allergic rhinitis with little or no seasonal exacerbations or nonallergic rhinitis
- •3. Patients with documented evidence of acute or chronic sinusitis, chronic purulent postnasal drip, rhinitis sicca, atrophic rhinitis or rhinitis medicamentosa as determined by the investigator.
- •4. Patients with nasal structure abnormalities, including nasal ulceration, nasal mucosal erosion, large nasal polyps, marked septal deviations and recent nasal surgery that significantly interfere with nasal air flow.
- •5. Patients with an active pulmonary disorder including asthma, upper respiratory tract or sinus infection that required antibiotic therapy within 14 days of the screening visit or a upper respiratory infection / ocular infection within 7 days of the screening visit.
- •6. Patients with history of narrow-angle glaucoma, increased intraocular pressure and posterior subcapsular cataract
- •7. Patients with abnormal laboratory values i.e. RBS > 140mg/dl, serum transaminases greater than or equal to 3 x Upper Normal Limit, serum bilirubin greater than or equal to 2.0 mg/dl and serum creatinine greater than or equal to 2.5 mg/dl
- •8. Patients with clinically significant uncontrolled systemic diseases such as gastrointestinal, cardiovascular, renal, neurological, psychiatric, endocrine, immunological or hematological disorders or malignancy
- •9. Pregnant or lactating females and females of child bearing age not willing to use double methods of contraception during the study period
- •10. Patients who have received the following medications in the given time frame: nasal or oral decongestants, nasal or oral antihistamines: 72 h; nasal or inhaled corticosteroids, leucotriene receptor antagonists, 5-lipoxygenase inhibitors, methylxanthines, non-prescription drugs: 7 days; MAO inhibitors: 14 days; oral corticosteroids: 12 weeks
- •11. Patients taking prohibited concomitant medication
- •12. Patients with continuing history of alcohol and/or drug abuse
- •13. Participation in another clinical trial in the past 3 months prior to screening
- •14. Any other reason for which the investigator feels that the patient should not participate
研究者
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