Pilot Efficacy and Safety Field Trial of Desloratadine Administered Concomitantly With Oxybutynin, in Subjects With Seasonal Allergic Rhinitis and Post-Nasal Drip
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 540
- 主要终点
- Change from baseline in mean daily AM/PM Prior post-nasal drip scores averaged over the entire treatment period
研究概览
简要总结
This was a 1-week study of desloratadine (DL) plus oxybutynin (OXY) at two dose levels in the treatment of post-nasal drip in participants with seasonal allergic rhinitis. Participants received either desloratadine twice a day, oxybutynin twice a day, desloratadine plus lower-dose oxybutynin twice a day, desloratadine plus higher-dose oxybutynin twice a day, or placebo for 7 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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects must:
- •be >=18 years of age,
- •be free of any clinically significant disease that would interfere with study, other than seasonal allergic rhinitis (SAR),
- •have a documented diagnosis of SAR for >=2 years,
- •have had a positive skin-prick test,
- •be sufficiently symptomatic at the Screening visit,
- •for the 3 calendar days immediately prior to baseline visit, plus the AM of the baseline visit, the seven twice-daily run-in diary PRIOR total nasal symptom scores must have totaled >=42, the Total Non-Nasal Symptoms score must have totaled >=28, and the total Post Nasal Drip score must have totaled >=14,
- •be in general good health.
排除标准
- •Subjects who have:
- •certain medical conditions or medical histories,
- •allergies to any of the components in any of the study medications,
- •nasal structure abnormalities,
- •dependency to nasal, oral, or ocular decongestants, nasal topical antihistamines, or nasal steroids,
- •used any investigational drug use in past 30 days,
- •received immunotherapy (desensitization)
- •are pregnant
研究组 & 干预措施
DL 2.5 mg
Desloratadine 2.5 mg twice daily (BID) + Placebo for Oxybutynin 2.5 mg BID for 7 days
干预措施: Desloratadine 2.5 mg (Drug)
DL 2.5 mg
Desloratadine 2.5 mg twice daily (BID) + Placebo for Oxybutynin 2.5 mg BID for 7 days
干预措施: Placebo for Oxybutynin 2.5 mg (Drug)
OXY 5 mg
Placebo for Desloratadine 2.5 mg BID + Oxybutynin 5 mg BID for 7 days
干预措施: Oxybutynin 2.5 mg (Drug)
OXY 5 mg
Placebo for Desloratadine 2.5 mg BID + Oxybutynin 5 mg BID for 7 days
干预措施: Placebo for Desloratadine 2.5 mg (Drug)
DL 2.5 mg + OXY 2.5 mg
Desloratadine 2.5 mg BID + Oxybutynin 2.5 mg BID + Placebo for Oxybutynin 2.5 mg BID for 7 days
干预措施: Desloratadine 2.5 mg (Drug)
DL 2.5 mg + OXY 2.5 mg
Desloratadine 2.5 mg BID + Oxybutynin 2.5 mg BID + Placebo for Oxybutynin 2.5 mg BID for 7 days
干预措施: Oxybutynin 2.5 mg (Drug)
DL 2.5 mg + OXY 2.5 mg
Desloratadine 2.5 mg BID + Oxybutynin 2.5 mg BID + Placebo for Oxybutynin 2.5 mg BID for 7 days
干预措施: Placebo for Oxybutynin 2.5 mg (Drug)
DL 2.5 mg + OXY 5 mg
Desloratadine 2.5 mg BID + Oxybutynin 5 mg BID for 7 days
干预措施: Desloratadine 2.5 mg (Drug)
DL 2.5 mg + OXY 5 mg
Desloratadine 2.5 mg BID + Oxybutynin 5 mg BID for 7 days
干预措施: Oxybutynin 2.5 mg (Drug)
Placebo
Placebo for Desloratadine 2.5 mg BID + Placebo for Oxybutynin 2.5 mg BID for 7 days
干预措施: Placebo for Desloratadine 2.5 mg (Drug)
Placebo
Placebo for Desloratadine 2.5 mg BID + Placebo for Oxybutynin 2.5 mg BID for 7 days
干预措施: Placebo for Oxybutynin 2.5 mg (Drug)
结局指标
主要结局
Change from baseline in mean daily AM/PM Prior post-nasal drip scores averaged over the entire treatment period
时间窗: Days 1 to 7 +/- 2 days
次要结局
- Anterior rhinorrhea averaged over Days 1 to 8(Days 1 to 8)