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NCT Number: NCT04469439

Impact of Sinus Surgery on Individuals With Cystic Fibrosis

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.

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Key information

Conditions

Chronic Rhinosinusitis (Diagnosis) Congenital, Hereditary, and Neonatal Diseases and Abnormalities Cystic Fibrosis Digestive System Diseases Disease Genetic Diseases, Inborn Infant, Newborn, Diseases Lung Diseases Pancreatic Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Respiratory Tract Diseases

Age range

18 year–99 year

Sex eligibility

All sexes

Study type

Observational

Primary location

University of California, Los Angeles, Los Angeles, California, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. 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)

  2. Change in days of inpatient hospitalization

    Time frame: baseline, 3, 6, 9, 12 months

    Days of inpatient hospitalization will be assessed

Secondary outcomes

  1. Change in quality of life

    Time frame: baseline, 3, 6, 9, 12 months

    Quality of life will be assessed using the 22-question SinoNasal Outcome test (range 0-110, with higher scores signifying worse quality of life)

  2. Change in quality of life

    Time frame: baseline, 3, 6, 9, 12 months

    Quality of life will be assessed using the Cystic Fibrosis Questionnaire-Revised instrument (range 0-100, with higher scores signifying worse quality of life)

  3. Change in olfaction

    Time frame: baseline, 3, 6, 9, 12 months

    Olfaction will be assessed using the Smell Identification Test (score range: 0-40, with higher scores demonstrated better olfactory ability)

Other outcomes

  1. Patient satisfaction regarding treatment for chronic rhinosinusitis

    Time frame: at baseline

    Satisfaction will be assessed using 5-point Likert scales, ranging from 1 to 5 with 1 signifying "not important" and 5 signifying "very important"

Study contacts

Contact information is provided by the study sponsor or research team.

Daniel M Beswick, MD

CONTACT

[email protected]

310-206-8457

Marlene Florian

CONTACT

[email protected]

424-946-5862

Sponsors and collaborators

Lead sponsor

University of California, Los Angeles

Other

Collaborators

  • Cystic Fibrosis Foundation

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2027
Study completion
2027
First posted
Jul 14, 2020
Registry last updated
Apr 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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