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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02003079
Recruitment Status : Completed
First Posted : December 6, 2013
Last Update Posted : November 21, 2014
Information provided by (Responsible Party):
Amin Javer, St. Paul's Hospital, Canada

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.

Condition or disease Intervention/treatment
Cystic Fibrosis Behavioral: Cystic Fibrosis Questionnaire (Revised) for Teens/Adults

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Study Type : Observational
Actual Enrollment : 113 participants
Observational Model: Cohort
Time Perspective: Cross-Sectional
Study Start Date : September 2013
Actual Primary Completion Date : March 2014
Actual Study Completion Date : June 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cystic Fibrosis

Group/Cohort Intervention/treatment
Diagnosed with or without Chronic Rhinosinusitis Behavioral: Cystic Fibrosis Questionnaire (Revised) for Teens/Adults

Primary Outcome Measures :
  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.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   19 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Adult individuals over the age of 19 years with a definitive diagnosis of Cystic Fibrosis.

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02003079

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Canada, British Columbia
St. Paul's Hospital
Vancouver, British Columbia, Canada, V5G 4S7
Sponsors and Collaborators
St. Paul's Hospital, Canada
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Principal Investigator: Amin R Javer, MD FRCSC FARS St Paul's Sinus Center
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Amin Javer, Director, St. Paul's Hospital, Canada Identifier: NCT02003079    
Other Study ID Numbers: CFSinus-001
First Posted: December 6, 2013    Key Record Dates
Last Update Posted: November 21, 2014
Last Verified: November 2014
Additional relevant MeSH terms:
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Cystic Fibrosis
Pathologic Processes
Pancreatic Diseases
Digestive System Diseases
Lung Diseases
Respiratory Tract Diseases
Genetic Diseases, Inborn
Infant, Newborn, Diseases