NCT00772304已完成4 期
Evaluation of the Sensory Attributes of Olopatadine 0.6% and Azelastine 137mcg Nasal Sprays in Patients w/Allergic Rhinitis
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 102
- 试验地点
- 1
- 主要终点
- Product Preference Questionnaire for Immediate Taste
研究概览
简要总结
To compare patient perceptions of the sensory attributes, including taste and aftertaste, of Olopatadine relative to azelastine when administered as a single dose in patients with allergic rhinitis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Must have a history (at least 2 yrs) of allergic rhinitis and be symptomatic at time of enrollment
- •18 yrs of age or older
- •Read and sign informed consent
- •Females of childbearing potential may participate if: are non-breast feeding, have negative urine pregnancy test at visit 1, agree to take urine pregnancy test upon exiting study, do not intend to become pregnant during the study, are using adequate methods of birth control.
排除标准
- •History of intolerance or hypersensitivity to any component of the study medications, including benzalkonium chloride.
- •Any disease or systemic disorder that may complicate or interfere with investigation or evaluation of the study medications (including but not limited to): Rhinitis medicamentosa, large obstructive nasal polyps, history (w/in last 3 months) of nasal septic ulcers, nasal surgery or nasal trauma, history or evidence of nasolacrimal drainage system malfunction, history (w/in 30 days) or evidence of sinusitis or upper or lower respiratory infection.
- •Impairment of sense of tast or smell (self reported)
- •Asthma, except for mild, intermittent asthma (nat'l Asthma guidelines)
- •Congestion, that in the opinion of the investigator, that would interfere with successful nasal drug administration/absorption
- •Patients w/a severe impairment of nasal breathing
- •Anatomic abnormalities of as identified by nasal examination
- •History of or current severe or uncontrolled cardiovascular, hepatic, renal and/or other disease/illness that could interfere w/study.
- •History of (w/in past 12 months) or ongoing clinically relevant electrolyte abnormalities.
研究组 & 干预措施
1
Experimental
Olopatadine 0.6% / Azelastine 137 mcg
干预措施: Olopatadine 0.6% / Azelastine 137 mcg (Drug)
结局指标
主要结局
Product Preference Questionnaire for Immediate Taste
时间窗: 5 min post-dose
Using a set of coded responses, subjects evaluated product preference in regards to immediate taste
次要结局
- Taste and Aftertaste of Medication(5 min, 45 min.)
研究者
研究点 (1)
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