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

NCT ID: NCT02003079

Last Updated: 2014-11-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

113 participants

Study Classification

OBSERVATIONAL

Study Start Date

2013-09-30

Study Completion Date

2014-06-30

Brief Summary

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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.

Detailed Description

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Conditions

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Cystic Fibrosis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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Diagnosed with or without Chronic Rhinosinusitis

Cystic Fibrosis Questionnaire (Revised) for Teens/Adults

Intervention Type BEHAVIORAL

Interventions

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Cystic Fibrosis Questionnaire (Revised) for Teens/Adults

Intervention Type BEHAVIORAL

Eligibility Criteria

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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.
Minimum Eligible Age

19 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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St. Paul's Hospital, Canada

OTHER

Sponsor Role lead

Responsible Party

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Amin Javer

Director

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Amin R Javer, MD FRCSC FARS

Role: PRINCIPAL_INVESTIGATOR

St Paul's Sinus Center

Locations

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St. Paul's Hospital

Vancouver, British Columbia, Canada

Site Status

Countries

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Canada

References

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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.

Reference Type DERIVED
PMID: 26011015 (View on PubMed)

Other Identifiers

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CFSinus-001

Identifier Type: -

Identifier Source: org_study_id