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

Cystic Fibrosis Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02003079
• Other study ID #: CFSinus-001
• Status: Completed
• Phase: N/A
• First received: July 11, 2013
• Last updated: November 19, 2014
• Start date: September 2013
• Est. completion date: June 2014

Study information

• Verified date: November 2014
• Source: St. Paul's Hospital, Canada
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 113
• Est. completion date: June 2014
• Est. primary completion date: March 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 19 Years and older

Eligibility

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.

Study Design

Observational Model: Cohort, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Cystic Fibrosis
• Fibrosis

Intervention

Behavioral:
• Cystic Fibrosis Questionnaire (Revised) for Teens/Adults

Locations

Country	Name	City	State
Canada	St. Paul's Hospital	Vancouver	British Columbia

Sponsors (1)

Lead Sponsor	Collaborator
St. Paul's Hospital, Canada

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Difference in Cystic Fibrosis-specific HRQoL score among those with and without CRS.	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.	One clinic visit (30 minutes)	No