Efficacy and Safety of Mometasone Furoate Aqueous Nasal Spray vs Placebo and Flonase® (Fluticasone Propionate) in Seasonal Allergic Rhinitis Patients (I94-001)
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 313
- 主要终点
- Change From Baseline in Total Nasal Symptom Score Averaged Over Day 1 Through Day 15 (Based on Participant Diaries)
研究概览
简要总结
The purpose of this study is to evaluate the efficacy and safety of mometasone furoate (SCH 32088) aqueous nasal spray 200 mcg once daily compared to placebo once daily in the treatment of participants with seasonal allergic rhinitis. Flonase (fluticasone propionate) nasal spray 200 mcg once daily has been chosen as the active control for this study.
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
- Double (Participant, Investigator)
盲法说明
Both participant and investigator were blinded to treatment identity. Because the mometasone furoate and fluticasone propionate bottles were not identical in appearance, a double-dummy study design was used and each bottle had a matching placebo. Thus, although participants received bottles of different appearance, they did not know whether bottles contained active substance or placebo.
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
- •2-year history of seasonal allergic rhinitis
- •Positive skin test response to a local seasonal allergen (current, or performed in investigator's office within the past year)
- •Good health and free of any unstable, clinically significant disease, other than allergic rhinitis, that would interfere with the study schedule or evaluation of seasonal allergic rhinitis
排除标准
- •Women who are pregnant or breastfeeding
- •Women of childbearing potential who are not using an acceptable form of birth control
- •Significant history of metabolic, cardiovascular, neurologic, hematologic, hepatic, gastrointestinal, cerebrovascular, respiratory, or renal disease, or any other disorder which, in the judgment of the investigator, could interfere with the study, or require treatment which might interfere with the study
- •Use of any chronic medication which could affect the course of seasonal allergic rhinitis
- •Asthma requiring chronic use of inhaled or systemic corticosteroids (inhaled bronchodilators are permitted for asthma treatment)
- •Current or history of frequent, clinically significant sinusitis or chronic purulent postnasal drip
- •Upper respiratory tract or sinus infection that requires antibiotic therapy within the previous 2 weeks, or a viral upper respiratory infection (URI) within the 7 days prior to Screening
- •Dependence upon nasal, oral or ocular decongestants, or nasal topical antihistamines, in the opinion of the investigator
- •Has rhinitis medicamentosa
- •Investigational drug use within the previous 30 days
- •Nasal structural abnormalities, including large nasal polyps and marked septal deviation, that significantly interfere with nasal air flow
- •Immunotherapy (desensitization therapy), unless on a stable maintenance schedule for at least one month prior to the Screening visit
- •History of multiple drug allergies, allergy to antihistamines or corticoids
- •History of psychosis, antagonistic personality, poor motivation, hypochondriasis, or any other emotional or intellectual problems that are likely to limit the validity of consent to participate in the study
研究组 & 干预措施
Mometasone furoate nasal spray
Participants receive 200 mcg of mometasone furoate nasal spray and fluticasone propionate placebo matching nasal spray once daily.
干预措施: Mometasone furoate (Drug)
Mometasone furoate nasal spray
Participants receive 200 mcg of mometasone furoate nasal spray and fluticasone propionate placebo matching nasal spray once daily.
干预措施: Fluticasone propionate placebo (Drug)
Fluticasone propionate nasal spray
Participants receive 200 mcg of fluticasone propionate nasal spray and mometasone furoate placebo matching nasal spray once daily.
干预措施: Fluticasone propionate (Drug)
Fluticasone propionate nasal spray
Participants receive 200 mcg of fluticasone propionate nasal spray and mometasone furoate placebo matching nasal spray once daily.
干预措施: Mometasone furoate placebo (Drug)
Placebo nasal spray
Participants receive mometasone furoate placebo matching nasal spray and fluticasone propionate placebo matching nasal spray once daily.
干预措施: Mometasone furoate placebo (Drug)
Placebo nasal spray
Participants receive mometasone furoate placebo matching nasal spray and fluticasone propionate placebo matching nasal spray once daily.
干预措施: Fluticasone propionate placebo (Drug)
结局指标
主要结局
Change From Baseline in Total Nasal Symptom Score Averaged Over Day 1 Through Day 15 (Based on Participant Diaries)
时间窗: Baseline and Day 1 through Day 15 (averaged over 15 days)
Change from baseline averaged over study Day 1 through study Day 15 was calculated for Total Nasal Symptom Score, based on participant diaries. Participants scored 4 symptoms (rhinorrhea, stuffiness, itching, sneezing) in their diaries using the following scale: 0=none, 1=mild, 2=moderate, 3=severe. The Total Nasal Symptom Score was the sum of the 4 individual scores (range=0-12; higher score indicating more frequent/severe nasal symptoms.) Change from baseline was the 15-day average score minus the baseline score. Scores were recorded twice daily, in the morning (AM) and night (PM). Average AM/PM scores were first calculated separately, then averaged together to obtain the 15-day average score. Baseline score was an average of the 3 AM scores and 3 PM scores preceding treatment. Negative changes indicated a decrease in symptom severity.
次要结局
- Change From Baseline in the Total Nasal Symptom Score at Day 4 (Physician Evaluation)(Baseline (Day 1) and Day 4)
- Response to Therapy at Day 4 (Physician Evaluation)(Day 4)
- Change From Baseline in the Total Nasal Symptom Score at Day 15 (Physician Evaluation)(Baseline (Day 1) and Day 15)
- Change From Baseline in Overall Condition of Seasonal Allergic Rhinitis at Day 15 (Participant Evaluation)(Baseline (Day 1) and Day 15)
- Change From Baseline in Overall Condition of Seasonal Allergic Rhinitis at Day 4 (Physician Evaluation)(Baseline (Day 1) and Day 4)
- Change From Baseline in Overall Condition of Seasonal Allergic Rhinitis at Day 15 (Physician Evaluation)(Baseline (Day 1) and Day 15)
- Change From Baseline in Overall Condition of Seasonal Allergic Rhinitis at Day 4 (Participant Evaluation)(Baseline (Day 1) and Day 4)
- Response to Therapy at Day 15 (Physician Evaluation)(Day 15)
- Response to Therapy at Day 4 (Participant Evaluation)(Day 4)
- Response to Therapy at Day 15 (Participant Evaluation)(Day 15)