Examining the effects of sinus surgery on cystic fibrosis patients

The Impact of Sinus Surgery in the Era of Highly Effective Modulatory Therapy

This study is testing whether sinus surgery can improve health and quality of life for cystic fibrosis patients who have ongoing sinus problems, compared to those just getting medical treatment.

Quick facts

• Study type: Observational
• Enrollment: 170 (estimated)
• Ages: 18 Years to 99 Years
• Sex: All
• Sponsor: University of California, Los Angeles (Academic / other)
• Locations: 9 sites (Los Angeles, California and 8 other locations)
• Trial ID: NCT04469439 on ClinicalTrials.gov

What this trial studies

This observational study investigates the outcomes of endoscopic sinus surgery in patients with cystic fibrosis who suffer from chronic rhinosinusitis. It includes a control group of patients receiving medical treatment for their condition. The study will assess various outcomes, including pulmonary function and quality of life, to determine the impact of surgical intervention compared to medical management. Participants will be monitored over time to evaluate their health status and treatment preferences.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 to 99 with cystic fibrosis and chronic rhinosinusitis symptoms that persist despite medical treatment.

Not a fit: Patients who have undergone endoscopic sinus surgery in the past year or those unable to complete follow-up surveys may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could improve treatment strategies for cystic fibrosis patients suffering from chronic rhinosinusitis, enhancing their quality of life.

How similar studies have performed: Other studies have shown promising results regarding the benefits of sinus surgery in cystic fibrosis patients, suggesting that this approach may be effective.

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

Where this trial is running

Los Angeles, California and 8 other locations

• University of California, Los Angeles — Los Angeles, California, United States (Recruiting)
• Stanford University — Stanford, California, United States (Recruiting)
• University of Colorado — Aurora, Colorado, United States (Recruiting)
• National Jewish Health — Denver, Colorado, United States (Recruiting)
• University of North Carolina — Chapel Hill, North Carolina, United States (Recruiting)
• Oregon Health Science University — Portland, Oregon, United States (Recruiting)
• Medical University of South Carolina — Charleston, South Carolina, United States (Recruiting)
• Vanderbilt University Medical Center — Nashville, Tennessee, United States (Recruiting)
• University of Utah — Salt Lake City, Utah, United States (Recruiting)

Study contacts

• Principal investigator: Daniel M Beswick, MD — University of California, Los Angeles
• Study coordinator: Daniel M Beswick, MD

Conditions Chronic Rhinosinusitis; Cystic Fibrosis; Endoscopic Sinus Surgery