NCT04469439 · University of California, Los Angeles
Impact of Sinus Surgery on Individuals With Cystic Fibrosis
What this study is about
This study will be a forward-looking, 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.
View original scientific description
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.
Primary outcome measures
Change in pulmonary function
Time frame: baseline, 3, 6, 9, 12 months
Pulmonary function will be measured using spirometry - the percent of predicted forced expiratory volume in the first second (ppFEV1)
Change in days of inpatient hospitalization
Time frame: baseline, 3, 6, 9, 12 months
Days of inpatient hospitalization will be assessed
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- 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).
- Diagnosed with cystic fibrosis as established by genetic testing combined with clinical assessment and/or sweat chloride
- Diagnosed with chronic rhinosinusitis by multidisciplinary sinusitis guidelines
- chronic rhinosinusitis symptoms persisting beyond initial medical treatment
- Counseled for endoscopic sinus surgery and ongoing medical therapy with each patient electing their preferred treatment
Exclusion criteria
- Underwent endoscopic sinus surgery in past 12 months
- Will obtain follow up care at non-participating institutions
- Unable to complete follow-up surveys
Where
- Los Angeles, California
- Stanford, California
- Aurora, Colorado
- Denver, Colorado
- Chapel Hill, North Carolina
- Portland, Oregon
- Charleston, South Carolina
- Nashville, Tennessee
- Salt Lake City, Utah
Collaborators
Cystic Fibrosis Foundation
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Apr 22, 2026 · Source of record for eligibility and locations