Efficacy of Macrolide and Glucocorticoid in the Treatment of Chronic Rhinosinusitis Patients After Endoscopic Sinus Surgery ( ESS)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02182492|
Recruitment Status : Completed
First Posted : July 8, 2014
Last Update Posted : October 11, 2016
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.
|Condition or disease||Intervention/treatment|
|Chronic Rhinosinusitis Endoscopic Sinus Surgery||Drug: Clarithromycin Drug: Glucocorticoid|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||187 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||Comparison of Different Efficacy of Macrolide and Glucocorticoid in the Treatment of Chronic Rhinosinusitis Patients After Endoscopic Sinus Surgery|
|Study Start Date :||January 2014|
|Primary Completion Date :||December 2015|
Fluticasone propionate nasal spray
Fluticasone propionate nasal spray 200 μg/d for 3 months
Clarithromycin 250 mg tablet once daily for 3 months
- 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. ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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|