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

NCT02003079 | Completed

• 1 other identifier: CFSinus-001
• Study Type: observational
• Target: 113
• Locations: 1 country
• Sites: 1

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.

Conditions

Cystic Fibrosis

Outcome Measures

Primary Outcomes (1)

• 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)

Study Arms (1)

Diagnosed with or without Chronic Rhinosinusitis

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

Interventions

Cystic Fibrosis Questionnaire (Revised) for Teens/Adults BEHAVIORAL

Diagnosed with or without Chronic Rhinosinusitis

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adult individuals over the age of 19 years with a definitive diagnosis of Cystic Fibrosis.

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• St. Paul's Hospital, Canada: lead

Study Sites (1)

St. Paul's Hospital

Vancouver, British Columbia, V5G 4S7, Canada

Location

Related Publications (1)

• Habib AR, Buxton JA, Singer J, Wilcox PG, Javer AR, Quon BS. Association between Chronic Rhinosinusitis and Health-Related Quality of Life in Adults with Cystic Fibrosis. Ann Am Thorac Soc. 2015 Aug;12(8):1163-9. doi: 10.1513/AnnalsATS.201504-191OC.

  PMID: 26011015 DERIVED

MeSH Terms

Conditions

Cystic Fibrosis

Interventions

Reoperation

Condition Hierarchy (Ancestors)

Pancreatic Diseases; Digestive System Diseases; Lung Diseases; Respiratory Tract Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Infant, Newborn, Diseases

Intervention Hierarchy (Ancestors)

Surgical Procedures, Operative

Study Officials

• Amin R Javer, MD FRCSC FARS

  St Paul's Sinus Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director

Study Record Dates

• First Submitted: July 11, 2013
• First Posted: December 6, 2013
• Study Start: September 1, 2013
• Primary Completion: March 1, 2014
• Study Completion: June 1, 2014
• Last Updated: November 21, 2014

Record last verified: 2014-11

Locations

CA (1)