NCT01199757已完成不适用
A Comparison of Patients on AVAMYS ® Versus NASONEX (A Trade Mark of Schering Corporation) and FLIXONASE ® on Key Health Outcome Measures
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 540
- 主要终点
- Evaluate the differences in Symtom Free Days (SFD) in patients receiving FF, MF or FP
研究概览
简要总结
Previous publications have indicated that Allergic Rhinitis (AR) patients suffering from both ocular and nasal symptoms have a greater burden of illness and lower quality of life than patients suffering from nasal symptoms alone. Fluticasone furoate (FF) acts against both nasal and ocular symptoms. The purpose of this study was to evaluate the differences in symptom control (both perceptually and objectively) and resource use for patients with current seasonal AR.
详细描述
- Allergic rhinitis (AR) is a common inflammatory condition of the upper respiratory tract, nasal cavity and eyes affecting up to 20% of the population in the United States and Europe. The bothersome nature of AR symptoms can severely affect daily activities including ability to work and examination performance and impact on quality of life (QoL) and psychosocial well being.
- This study assesses the impact of Fluticasone furoate (FF) on the QoL of seasonal allergic rhinitis (SAR) patients, including the number of symptom-free days (SFD) and quality of life over the last 4 weeks, and compares this with other inhaled nasal steroids (INS): mometasone furate (MF) and fluticasone proprionate (FP).
- Selected physicians provide information including a range of demographic, symptom and treatment details for a number of their SAR patients. The patient themselves are then invited to provide details about their SAR including symptoms, the impact of AR upon their lifestyles, attitudes to treatment and completion of Health Related Quality of Life (HRQoL) instruments.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Cross Sectional
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Current Seasonal Allergic Rhinitis sufferer (based on physician judgement)
- •Currently receiving prescribed INS treatment (no other treatment restrictions apply)
- •Have consumed at least one full prescription on the specified INS treatment
- •No comorbid Asthma or COPD diagnosis
- •Informed Consent
排除标准
- •None specified
研究组 & 干预措施
FF
Cohort of patients receiving fluticasome furoate
干预措施: Fluticasone furoate (Drug)
MF
cohort of patients on mometasone furoate
干预措施: mometasone furoate (Drug)
FP
cohort of patients receiving fluticasone propionate
干预措施: fluticasone propionate (Drug)
结局指标
主要结局
Evaluate the differences in Symtom Free Days (SFD) in patients receiving FF, MF or FP
时间窗: 4 weeks
次要结局
- Evaluate the differences in the number of AR treatments used by patients receiving FF, MF or FP(4 weeks)
- Evaluate the differences in productivitiy (Work Productivity and Activity Impairment Questionnaire) of patients receiving FF, MF or FP(4 weeks)
- Evaluate the differences in Quality of Life (mini-Rhinoconjunctivitis Quality of Life Questionnaire) in patients receiving FF, MF or FP(4 weeks)
- Evaluate the differences in the number of non-prescribed treatments used by patients receiving FF, MF or FP(4 weeks)
- Evaluate the differences in the cost of non-prescribed treatments used by patients receiving FF, MF or FP(4 weeks)
- Evaluate the differences in the Pittsburgh Sleep Quality Index in patients receiving FF, MF or FP(4 weeks)
- Evaluate the differences in number of work day lost by patients receiving FF, MF or FP(4 weeks)
- Evaluate the differences in the number of physician visits (as reported by patient and doctor) by patients receiving FF, MF or FP(4 weeks)
研究者
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