A Study Of Ciliary Function In Recalcitrant Chronic Rhinosinusitis

Overview

About this study

The purpose of this study is to evaluate ciliary structure in both “healthy appearing” and “non-healthy appearing” tissue of the same patient with recalcitrant CRS and endoscopic findings of focal purulent inflammation to better understand if ciliary structure is contributing to the refractory disease. 

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

Inclusion Criteria:

  • 18 years old or older

  • Male or female

  • Confirmed diagnosis of chronic rhinosinusitis status post complete sinus surgery and recalcitrant sinus disease based on symptomatic recurrent or persistent sinus symptoms such as nasal drainage, nasal obstruction or congestion, decreased sense of smell, and facial discomfort

  • Nasal endoscopy must identify inflammation of the paranasal sinuses, described as focal, patchy or diffuse, and be associated with a positive bacterial nasal (paranasal) culture

  • Previous or current diagnosis of primary or secondary immunodeficiency based on clinical history or laboratory findings

  • Treatment with topical sinus steroid irrigation or spray as well as at least one course of culture directed systemic antibiotics

  • IVIG and oral or nasal antihistamines during or prior to enrollment and throughout the study

  • Complete the nasal biopsies prior to initiation of topical nasal antibiotic irrigation

 

Exclusion Criteria:

  • Under the age of 18 years old

  • Not completed appropriate standard of care medical therapy including topical steroids, nasal saline irrigation, and at least on course of oral antibiotics.+Patients who have not had full house (complete) endoscopic sinus surgery

  • Nasal endoscopy shows no evidence of persistent or recurrent inflammation

  • Unable to tolerate in office biopsy of paranasal sinus mucosa for evaluation of mucociliary clearance function

  • Inability to understand study procedures and to comply with them for the entire length of the study

  • Use oral prednisone within 14 days of diagnostic testing.

  • Inability or unwillingness of individual or legal guardian/representative to give written informed consent

Note: Other protocol defined Inclusion/Exclusion Criteria may apply.

Eligibility last updated 05/02/2026. Questions regarding updates should be directed to the study team contact.

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

Janalee Stokken, M.D.

Open for enrollment

Contact information:

Diane Vogen

5072661247

vogen.diane2@mayo.edu

Jacksonville, Fla.

Mayo Clinic principal investigator

Angela Donaldson, M.D.

Contact us for the latest status

Contact information:

Elizabeth Martin

9049532800

martin.elizabeth1@mayo.edu

More information

Publications

Publications are currently not available
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CLS-20603574

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