Onset of Action of Mometasone Furoate (SCH 32088) Nasal Spray 50 mcg/Spray vs Placebo in Seasonal Allergic Rhinitis (Study No. C93-184).
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 201
- 主要终点
- Median Time to Onset of Nasal Symptom Relief as Assessed by Participant Diary Responses
研究概览
简要总结
This study investigated the onset of symptom relief following initiation of treatment with mometasone furoate (MK-0887/SCH 032088) 200 mcg administered once daily compared with placebo for 14 days.
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
- •Has a 2-year history of seasonal allergic rhinitis
- •Has a positive skin test response to a local seasonal allergen (current, or performed in investigator's office within the past year)
- •Is in 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
- •Has asthma that requires therapy with inhaled or systemic corticosteroids, cromolyn, or nedocromil
- •Has significant renal, hepatic, neurologic, cardiovascular, hematologic, metabolic, cerebrovascular, respiratory, gastrointestinal, or other significant medical illness or disorder which, in the judgment of the investigator, could interfere with the study, or required treatment which might interfere with the study
- •Is on immunotherapy with the exception of maintenance therapy
- •Has a clinically significant upper respiratory or sinus infection
- •Has used an investigational drug within the previous 30 days
- •Has nasal structural abnormalities, including large nasal polyps and marked septal deviation, that significantly interfere with nasal air flow
- •Has a history of multiple drug allergies or an allergy to antihistamines or corticoids
- •Has dependence upon nasal, oral or ocular decongestants, or nasal topical antihistamines, in the opinion of the investigator
- •Has rhinitis medicamentosa
- •Is using of any chronic medication which could affect the course of seasonal allergic rhinitis
研究组 & 干预措施
mometasone furoate nasal spray
Participants administered mometasone furoate nasal spray 200 mcg once daily (QD), as two 50 mcg sprays per nostril, for 14 consecutive days.
干预措施: mometasone furoate nasal spray (Drug)
placebo nasal spray
Participants administered placebo nasal spray QD, as two placebo sprays per nostril, for 14 consecutive days.
干预措施: placebo nasal spray (Drug)
结局指标
主要结局
Median Time to Onset of Nasal Symptom Relief as Assessed by Participant Diary Responses
时间窗: From the start of treatment until onset of symptom relief (up to Day 4)
Time to onset of relief of nasal stuffiness/congestion, rhinorrhea, nasal itching, sneezing, itching/burning eyes, tearing/watering eyes, redness of eyes, and itching of ears or palate was assessed by the participant using diary response data in the morning and night for the first 3 days of treatment. The participants were asked to rate their relief on the following scale: 1=complete, 2=marked, 3=moderate, 4=slight, and 5=none. If a participant recorded a degree of relief that was at least moderate (3 or below), they answered the question, "When did you first experience noticeable relief?" and noted the date and time. The data were analyzed using a log ranked test and with a Kaplan-Meier estimate. Any participant who did not experience at least moderate relief by the end of 72 hours was considered censored at that time in the analysis. Time to onset of relief is presented in hours.
次要结局
- Change From Baseline (CFB) in the Total Nasal Symptom Score (TNSS) at Day 15 as Assessed by Investigator(Baseline (Day 1) and Final Endpoint (Up to Day 15). The final endpoint was calculated using the last valid visit for each participant due to missing data at Day 15.)
- Change From Baseline (CFB) in Overall Disease Condition Score at Day 4 as Assessed by Investigator(Baseline (Day 1) and Day 4)
- Change From Baseline (CFB) in Overall Disease Condition Score at Day 8 as Assessed by Investigator(Baseline (Day 1) and Day 8)
- Change From Baseline (CFB) in the Total Nasal Symptom Score (TNSS) Averaged Over 15 Days of Treatment, as Assessed by Participant(Baseline (3 days preceding treatment) through Day 15 (averaged over 15 days))
- Change From Baseline (CFB) in the Total Nasal Symptom Score (TNSS) at Day 4 as Assessed by Investigator(Baseline (Day 1) and Day 4)
- Change From Baseline (CFB) in the Total Nasal Symptom Score (TNSS) at Day 8 as Assessed by Investigator(Baseline (Day 1) and Day 8)
- Change From Baseline in Overall Disease Condition Score at Day 15 as Assessed by Investigator(Baseline (Day 1) and Final Endpoint (Up to Day 15). The final endpoint was calculated using the last valid visit for each participant due to missing data at Day 15.)
- Change From Baseline (CFB) in Overall Disease Condition Score at Day 4 as Assessed by Participant(Baseline (Day 1) and Day 4)
- Change From Baseline (CFB) in Overall Disease Condition Score at Day 8 as Assessed by Participant(Baseline (Day 1) and Day 8)
- Change From Baseline (CFB) in Overall Disease Condition Score at Day 15 as Assessed by Participant(Baseline (Day 1) and Day 15)
- Therapeutic Response to Treatment at Day 4 as Assessed by Investigator(Day 4)
- Therapeutic Response to Treatment at Day 8 as Assessed by Investigator(Day 8)
- Therapeutic Response to Treatment at Day 15 as Assessed by Investigator(Final Endpoint (Up to Day 15). The final endpoint was calculated using the last valid visit for each participant due to missing data at Day 15.)
- Therapeutic Response to Treatment at Day 4 as Assessed by Participant(Day 4)
- Therapeutic Response to Treatment at Day 8 as Assessed by Participant(Day 8)
- Therapeutic Response to Treatment at Day 15 as Assessed by Participant(Day 15)