Clinical trial NCT04469439: Impact of Sinus Surgery on Individuals With Cystic Fibrosis
Official title: The Impact of Sinus Surgery in the Era of Highly Effective Modulatory Therapy
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Chronic Rhinosinusitis (Diagnosis)
Cystic Fibrosis
Keywords: Chronic Rhinosinusitis
Cystic Fibrosis
Endoscopic Sinus Surgery
Lead sponsor: University of California, Los Angeles
Sponsor class: OTHER
Collaborators: name: Cystic Fibrosis Foundation
First posted: 2020-07-14
Enrollment: 170
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subjects will be recruited from cystic fibrosis and otolaryngology outpatient clinics.

Brief summary: This study will be a prospective, observational study of patients who undergo endoscopic sinus surgery for cystic fibrosis-related chronic rhinosinusitis (CRS). Individuals who do not undergo surgery but are treated medically for CRS will also be enrolled to serve as a control group. Outcomes analyzed will include pulmonary, quality of life, and others.


Eligibility criteria: Inclusion Criteria:

1. Subjects between the ages of 18 years old (inclusive) and 99 years old (inclusive, subjects over the age of 89 will be recorded to be 89 years old).
2. Diagnosed with cystic fibrosis as established by genetic testing combined with clinical assessment and/or sweat chloride
3. Diagnosed with chronic rhinosinusitis by multidisciplinary sinusitis guidelines
4. chronic rhinosinusitis symptoms persisting beyond initial medical treatment
5. Counseled for endoscopic sinus surgery and ongoing medical therapy with each patient electing their preferred treatment

Exclusion Criteria:

1. Underwent endoscopic sinus surgery in past 12 months
2. Will obtain follow up care at non-participating institutions
3. Unable to complete follow-up surveys

Primary outcomes:
measure: Change in pulmonary function
timeFrame: baseline, 3, 6, 9, 12 months
measure: Change in days of inpatient hospitalization
timeFrame: baseline, 3, 6, 9, 12 months
Secondary outcomes:
measure: Change in quality of life
timeFrame: baseline, 3, 6, 9, 12 months
measure: Change in quality of life
timeFrame: baseline, 3, 6, 9, 12 months
measure: Change in olfaction
timeFrame: baseline, 3, 6, 9, 12 months
Other outcomes:
measure: Patient satisfaction regarding treatment for chronic rhinosinusitis
timeFrame: at baseline
Locations:
city: Los Angeles
country: United States
facility: University of California, Los Angeles
state: California
city: Stanford
country: United States
facility: Stanford University
state: California
city: Aurora
country: United States
facility: University of Colorado
state: Colorado
city: Denver
country: United States
facility: National Jewish Health
state: Colorado
city: Chapel Hill
country: United States
facility: University of North Carolina
state: North Carolina
city: Portland
country: United States
facility: Oregon Health Science University
state: Oregon
city: Charleston
country: United States
facility: Medical University of South Carolina
state: South Carolina
city: Nashville
country: United States
facility: Vanderbilt University Medical Center
state: Tennessee
city: Salt Lake City
country: United States
facility: University of Utah
state: Utah
Study officials:
affiliation: University of California, Los Angeles
name: Daniel M Beswick, MD
role: PRINCIPAL_INVESTIGATOR
References: