NCT00783237已完成4 期
Onset of Action of Mometasone Furoate Nasal Spray vs. Placebo in Induced Allergic Rhinitis
适应症
干预措施
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 340
- 主要终点
- Total Nasal Symptom Score (TNSS)
研究概览
简要总结
This was a single-dose study to determine the time it takes for mometasone furoate nasal spray to go in effect, after a single dose of 2 sprays per nostril. Patients who are eligible were exposed to ragweed pollen for 3 hours on one or two occasions. Patients who experienced adequate symptoms during the pollen exposure phase came back for a Treatment Phase visit. During the Treatment Phase visit, patients were exposed to ragweed pollen for 2 hours and then received either mometasone or placebo nasal spray. Symptom evaluations began on the patients every hour for the next 11 hours.
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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 12 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •at least 12 years old,
- •had a history of SAR to ragweed pollen for at least one year
- •had a positive skin test (prick) to short ragweed allergen.
- •if female, had a negative urine pregnancy test (HCG) at the Screening Visit, and prior to treatment on the Treatment Visit
- •were non pregnant women of childbearing potential and used a medically acceptable, adequate form of birth control.
排除标准
- •developed signs or symptoms of bronchospasm, i.e., wheezing, dyspnea, and/or cough, during the priming sessions;
- •had any significant medical condition which, in the judgment of the investigator, might interfere with the study or require treatment;
- •had an upper respiratory or sinus infection within two weeks prior to treatment;
- •had received escalating doses of immunotherapy, oral immunotherapy or short course (rush) immunotherapy for treatment of rhinitis;
- •were female subjects who were pregnant, breast feeding, or premenarchal;
- •could not adhere to concomitant medication prohibitions;
- •had a known potential for hypersensitivity, allergy, or idiosyncratic reaction to mometasone furoate nasal spray;
- •had asthma that requires systemic or inhaled corticosteroid treatment;
- •had large nasal polyps, marked septum deviations, or any other nasal structural abnormality that significantly interferes with nasal airflow;
- •had rhinitis medicamentosa;
- •had any relevant abnormal vital sign due to an unknown underlying disease and considered by the investigator and Sponsor Monitor to contraindicate study participation.
研究组 & 干预措施
Mometasone Furoate Nasal Spray
Experimental
干预措施: Mometasone (Drug)
Placebo Nasal Spray
Placebo Comparator
干预措施: Placebo (Drug)
结局指标
主要结局
Total Nasal Symptom Score (TNSS)
时间窗: On the day of treatment, after 90 and 120 minutes of pollen exposure and every 60 minutes post-dose for 12 hours
次要结局
- Nasal and Non-Nasal symptoms, Total Nasal and Total Non-Nasal symptoms, Total Symptom Score, Global Therapeutic Response(On the day of treatment, after 90 and 120 minutes of pollen exposure and every 60 minutes post-dose for 12 hours)
研究者
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