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Clinical Trials/NCT02003079
NCT02003079
Completed
Not Applicable

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

St. Paul's Hospital, Canada1 site in 1 country113 target enrollmentSeptember 2013
ConditionsCystic Fibrosis

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Cystic Fibrosis
Sponsor
St. Paul's Hospital, Canada
Enrollment
113
Locations
1
Primary Endpoint
Difference in Cystic Fibrosis-specific HRQoL score among those with and without CRS.
Status
Completed
Last Updated
11 years ago

Overview

Brief Summary

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.

Registry
clinicaltrials.gov
Start Date
September 2013
End Date
June 2014
Last Updated
11 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
St. Paul's Hospital, Canada
Responsible Party
Principal Investigator
Principal Investigator

Amin Javer

Director

St. Paul's Hospital, Canada

Eligibility Criteria

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.

Outcomes

Primary Outcomes

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.

Study Sites (1)

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