Efficacy of Macrolide and Glucocorticoid in the Treatment of Chronic Rhinosinusitis Patients After Endoscopic Sinus Surgery ( ESS)
Endoscopic sinus surgery (ESS) is widely considered to be the gold standard in the surgical management of chronic rhinosinusitis (CRS) that has failed maximal medical therapy. Nevertheless, the postoperation medical therapy was considered as a crucial procedure for the success of ESS. Both glucocorticoids and macrolide antibiotics have been recommended for the treatment of CRS, but their effect as postoperation medical therapies of ESS need more clinical data to clarify.
The purpose of this prospective, randomized,study is to determine the effect of glucocorticoids and macrolide antibiotics for the postoperation medical therapy of ESS in different subtypes of CRS.
|Chronic Rhinosinusitis Endoscopic Sinus Surgery||Drug: Clarithromycin Drug: Glucocorticoid|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||Comparison of Different Efficacy of Macrolide and Glucocorticoid in the Treatment of Chronic Rhinosinusitis Patients After Endoscopic Sinus Surgery|
- Change of subjective symptoms visual analog scores [ Time Frame: Scores will be recorded just before ESS and at 1-, 3-, 6- and 12-month follow-up visit. ]The treatment will begin one week after ESS.
- Change of nasal endoscopic scores [ Time Frame: Scores will be recorded just before ESS and at 1-, 3-, 6- and 12-month follow-up visit. ]The treatment will begin one week after ESS.
- Measurement of protein levels of inflammatory molecules in tissues [ Time Frame: Polyp tissues from CRSwNP patients and diseased sinus mucosa from CRSsNP patients will be collected during surgery. ]
|Study Start Date:||January 2014|
|Primary Completion Date:||December 2015 (Final data collection date for primary outcome measure)|
Fluticasone propionate nasal spray
Fluticasone propionate nasal spray 200 μg/d for 3 months
Clarithromycin 250 mg tablet once daily for 3 months
Please refer to this study by its ClinicalTrials.gov identifier: NCT02182492
|Department of ENT, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology|
|Wuhan, Hubei, China, 430030|
|Study Director:||Zheng Liu, Doctor||Professor of Otolaryngology-Head & Neck Surgery Vice Director Department of ENT Tongji Hospital Tongji Medical College Huazhong University of Science and Technology|