Assessment of the Effectiveness of Regular Use of Intranasal Steroids in Alleviating Nasal Symptoms in Allergic Rhinitis When Used Alone or in Combination With Oral Antihistamine
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 72
- 主要终点
- To assess the mean change in total nasal symptom score from Baseline to the Final Visit of regular intranasal steroid use (mometasone furoate) in allergic rhinitis patients when used alone or in combination with an oral antihistamine.
研究概览
简要总结
This is a Phase 4, non-comparative, open-label, multi-center study. It is designed to determine the effectiveness of regular intranasal steroid use in alleviating allergic rhinitis nasal symptoms, when used alone or in combination with an oral antihistamine. Subjects will receive 200 mcg (2 puffs in each nostril) of mometasone furoate once a day. An oral antihistamine at the discretion of the physician may be added at Day 28 (Visit 2), if patients fail to improve nasal symptoms.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects must demonstrate their willingness to participate in the study and comply with its procedures by signing a written informed consent form
- •Subjects must be between 18-65 years of age, of either sex and any race
- •Subjects must be diagnosed by the physician to have moderate to severe allergic rhinitis according to ARIA guidelines.
- •Subjects must be mometasone furoate naïve.
排除标准
- •Significant comorbid medical condition.
- •Respiratory tract infection.
- •Any contraindications according to mometasone furoate product monograph.
- •Patients who have received antihistamine treatment within the last 5 days.
- •Patients who have received corticosteroid treatment within the last 30 days.
- •Patients who are likely to require the administration of systemic steroids during the course of this program.
- •Any condition which in the doctor's opinion could interfere with the patient completion of this program.
- •Pregnant or lactating patients.
- •Patients with local infections involving the nasal mucosa.
- •Patients with structural abnormalities or who have undergone nasal surgery or trauma in the past 6 months.
- •Patients with hypersensitivity to mometasone furoate or are allergic to corticosteroids.
- •Patients who are prone to nose bleeding.
研究组 & 干预措施
Mometasone furoate
干预措施: Mometasone furoate (Drug)
Mometasone furoate plus an oral antihistamine
干预措施: Mometasone furoate (Drug)
结局指标
主要结局
To assess the mean change in total nasal symptom score from Baseline to the Final Visit of regular intranasal steroid use (mometasone furoate) in allergic rhinitis patients when used alone or in combination with an oral antihistamine.
时间窗: Day 28 and Day 56
次要结局
- Patient satisfaction with intranasal steroid monotherapy.(Day 28)
- Potential benefit of an oral antihistamine in combination with an intranasal steroid(Day 56)