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OpenTrials
Completed

NCT Number: NCT02003079

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

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.

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Key information

Age range

19 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

St. Paul's Hospital

Vancouver, British Columbia, V5G 4S7, Canada

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

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

Treatment and study plan

Cystic Fibrosis Questionnaire (Revised) for Teens/Adults

Behavioral

Primary outcomes

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

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

St. Paul's Hospital, Canada

Other

Registry information

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Dec 6, 2013
Registry last updated
Nov 21, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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