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临床试验/NCT01875276
NCT01875276已完成不适用

Evaluating the Need for a New Combination Nasal Spray in the Treatment of Seasonal Rhinitis

Research in Real-Life Ltd1 个研究点 分布在 1 个国家目标入组 21,203 人开始时间: 2013年1月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
21,203
试验地点
1
主要终点
Asthma Patients - Exacerbations: Severe

研究概览

简要总结

The proposed study will evaluate the unmet therapy need in seasonal rhinitis by aiming to answer the following research questions

  1. What is the first prescription of the hay-fever season and how many of these patients are on some form of combination therapy?
  2. To what extent does initial therapy not meet clinical need (as measured by need for additional medical intervention in terms of consultations and changes in therapy)?
  3. Does treatment for allergic rhinitis differ for asthma Vs non-asthma and seasonal Vs perennial patients?

详细描述

Allergic rhinitis is a chronic respiratory disease with a major impact on quality of life. In a study looking at the burden of allergic rhinitis amongst UK patients 75% reported some impact of their allergic rhinitis symptoms on health-related quality of life. Allergic rhinitis currently affects 10-30% of the world population with prevalence and impact continuing to increase. This leads to substantial economic costs both of prescription medication and time taken off work by both patients and carers due to the disease. In view of this, there may be a substantial need for improved therapy or management to ensure that patients with allergic rhinitis can carry out a normal lifestyle.

The proposed study will evaluate the unmet therapy need in seasonal rhinitis by examining the current medication requirements of patients who suffer from seasonal grass-pollen hay fever and determining whether current therapies are sufficient for managing rhinitis.

This study aims to evaluate the unmet therapy need in seasonal rhinitis by -

  1. Examining and describing current medication requirements
  2. Quantifying the extent of co-prescribing of multiple agents
  3. Comparing the effectiveness of current prescription drugs for managing and controlling patient's seasonal rhinitis and using changes in treatment during the hay fever season to determine the effectiveness of current therapy options.

for managing and controlling seasonal rhinitis in primary care patients who suffer from seasonal grass-pollen hay fever.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Retrospective

入排标准

性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

结局指标

主要结局

Asthma Patients - Exacerbations: Severe

时间窗: 10.12.12

b)Asthma related - Hospital attendance/admission OR A \& E attendance; OR Out-of-hours attendance; GP consultations for asthma related tract infections; Acute use of oral steroids

Co-prescribing

时间窗: 31.11.12

The proportion of patients managed at the index prescription date with more than one class of therapy

Number of Consultations

时间窗: 10.12.12

Defined as a consultation where an allergic rhinitis read code or hay fever code is recorded during the hay fever season.

Costing Analysis

时间窗: 15.01.13

Descriptive analysis of costs at the first prescription and final prescription of the season. Comparing those who remain on same therapy and those who add therapy during the season.

Treatment Outcomes

时间窗: 10.12.12

For those patients who receive a prescription for a diagnosis of seasonal rhinitis/ hay fever. The following outcomes will be measured - * Patients who remain on the same therapy * Patients who change therapy within same therapy group * Patients who add additional therapy from another therapy group

Asthma Patients - Exacerbations: Clinical

时间窗: 10.12.12

where exacerbation is defined as an occurrence of the following: a)Lower respiratory related : Hospital attendance/admission OR A \& E attendance; OR Out-of-hours attendance; * GP consultations for lower respiratory related tract infections; * Acute use of oral steroids .

次要结局

未报告次要终点

研究者

发起方
Research in Real-Life Ltd
申办方类型
Network
责任方
Principal Investigator
主要研究者

David Price, Prof., MD

Professor David Price

Research in Real-Life Ltd

研究点 (1)

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