Status:
WITHDRAWN
Trial of Directed High-dose Nasal Steroids on Residual Smell Loss in Sinus Patients After Sinus Surgery
Lead Sponsor:
University of North Carolina, Chapel Hill
Conditions:
Olfaction Disorders
Sinusitis
Eligibility:
All Genders
18-84 years
Phase:
PHASE2
Brief Summary
The purpose of this study is to determine if a trial of directed high-dose nasal steroids improves residual smell loss in patients with chronic rhinosinusitis following sinus surgery. Other outcomes o...
Detailed Description
OVERVIEW: This is a prospective randomized cohort study assessing the use of directed high-dose nasal steroids for improving olfactory function after endoscopic sinus surgery for chronic rhinosinusit...
Eligibility Criteria
Inclusion
- Patients who are otherwise healthy undergoing surgery for treatment of chronic rhinosinusitis will be evaluated for olfactory dysfunction, and if present, will be recruited for study participation. The subjects will be included without regard to their gender, race or ethnicity. Subjects will be identified from patients in the clinical practices of the Department of Otolaryngology - Head and Neck Surgery at the University of North Carolina. Only adult patients greater than 18 years old and less than 85 will be approached for this study, as patient treatment algorithms outside this range tend to vary with greater frequency. Due to limited resources, only patients fluent in English will be included, thus minimizing confounding variables and hurdles to patient communication, as some clinics do not have interpreting services. Also, most of the quality of life surveys and olfactory testing do not have non English versions. Only patients with health insurance will be included in the study in order to ensure all participants have access to the study drug.
Exclusion
- If the patient is a premenopausal woman, she will be asked if she is pregnant or breastfeeding. If she is either of these, she will be excluded from the study. All remaining women will receive a urine pregnancy test. If this urine pregnancy test is positive, the patient will be excluded from the study. Thus, for premenopausal female patients, a negative urine pregnancy test is necessary for inclusion in the study because of the need for repeat CTs and the possible systemic manifestations due to steroid irrigation. Further exclusion criteria will include the following: hypersensitivity to cortisol, history of pituitary disease, and allergic disease with subsequent anaphylaxis or breathing difficulties. Additionally, patients with a history of immunodeficiency, autoimmune disease, cystic fibrosis, or previous sinus surgery will be excluded as these co-morbidities might cloud the relationship between the treatment and the outcome.
Key Trial Info
Start Date :
March 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2013
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT01814618
Start Date
March 1 2013
End Date
November 1 2013
Last Update
April 6 2016
Active Locations (1)
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1
UNC Chapel Hill Department of Otolaryngology/Head and Neck Surgery
Chapel Hill, North Carolina, United States, 27514