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临床试验/NCT02003079
NCT02003079已完成不适用

Evaluating the Impact of Chronic Rhinosinusitis on the Health-Related Quality of Life Among Adults With Cystic Fibrosis

St. Paul's Hospital, Canada1 个研究点 分布在 1 个国家目标入组 113 人开始时间: 2013年9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
113
试验地点
1
主要终点
Difference in Cystic Fibrosis-specific HRQoL score among those with and without CRS.

研究概览

简要总结

Individuals with Cystic Fibrosis (CF) have a defective protein, which is known as the cystic-fibrosis transmembrane regulator (CFTR). The CFTR transports salt and hydrates mucous. CFTR defects may result in the accumulation of thick mucous in the sinus cavities. As a result, the tiny hair-like structures that sweep mucous out of the sinuses cannot function properly, which can lead to recurrent infection and swelling of the sinus walls. When symptoms are persistent for more than 12 weeks, this is known as chronic rhinosinusitis (CRS). The symptoms that are associated with CRS are nasal discharge, congestion, facial pain or pressure and reduced sense of smell. CRS in non-CF patients affects a large number of individuals in Canada and has been found to be associated with poor quality of life. In the CF population the life expectancy is increasing but chronic disease like CRS is becoming increasingly prevalent. Investigators currently do not know the impact that CRS has on the health-related quality of life in adults with CF and how many suffer from symptoms. The investigators aim to determine the impact of CRS among adults with CF, in order to gain a better understanding of chronic disease among these individuals. The investigators strongly feel this research will improve the referral processes between Respirologists and Otolaryngologists, thereby improving treatment and quality of life for patients.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Cross Sectional

入排标准

年龄范围
19 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 19 years of age or older
  • Definitive diagnosis of cystic fibrosis from positive genetic or sweat chloride test
  • Currently enrolled at the St. Paul's Cystic Fibrosis Clinic

排除标准

  • Individuals unable to understand the purpose, methods and conduct of this study.
  • Patients unwilling to provide informed consent.

结局指标

主要结局

Difference in Cystic Fibrosis-specific HRQoL score among those with and without CRS.

时间窗: One clinic visit (30 minutes)

Subjects will complete questionnaires meant to assess the severity of their symptoms as a cumulative experience of the last two weeks leading up to the visit. Subjects will also undergo nasal endoscopy examination during the same visit. All of the study procedures and data collection will be completed in one visit.

次要结局

未报告次要终点

研究者

发起方
St. Paul's Hospital, Canada
申办方类型
Other
责任方
Principal Investigator
主要研究者

Amin Javer

Director

St. Paul's Hospital, Canada

研究点 (1)

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