Efficacy of Macrolide and Glucocorticoid in the Treatment of Chronic Rhinosinusitis After Endoscopic Sinus Surgery
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|ClinicalTrials.gov Identifier: NCT02182492|
Recruitment Status : Completed
First Posted : July 8, 2014
Results First Posted : September 25, 2018
Last Update Posted : September 25, 2018
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||Phase|
|Chronic Rhinosinusitis Endoscopic Sinus Surgery||Drug: Clarithromycin Drug: Glucocorticoid||Not Applicable|
|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|
|Actual Primary Completion Date :||December 2015|
|Actual Study Completion Date :||June 2016|
Fluticasone propionate nasal spray
Fluticasone propionate nasal spray 200 μg/d for 3 months
Other Name: FLIXONASE
Clarithromycin 250 mg tablet once daily for 3 months
Other Name: KLACID
- Total Subjective Symptoms Visual Analog Scores (VAS) [ 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. Symptoms visual analog scores (VAS) were recorded just before ESS and at 1-, 3-, 6- and 12-month follow-up visit. All of the patients were assessed by using symptom questionnaire after enrollment and at follow-up visits. Subjective symptoms were scored by patients on a VAS of 0-10, with 0 being "no complaint whatsoever" and 10 being "the worst imaginable complaint."Five major symptoms were focused on: nasal obstruction, rhinorrhea, loss of sense of smell, facial pain or pressure, and headache. Total VAS score was calculated based on the sum of VAS scores of these five symptom domains. Total subjective symptoms VAS range: 0~50, with higher scores indicating greater severity of symptoms.
- Total Nasal Endoscopic Scores [ Time Frame: Scores will be recorded just before ESS and at 1-, 3-, 6- and 12-month follow-up visit. ]Nasal endoscopic evaluation was performed by the senior investigator who remained blinded to the treatment, including poly size: 0, absence of polyps; 1, polyps in middle meatus only; 2, polyps beyond middle meatus but not blocking the nose completely; and 3, polyps completely obstructing the nose; discharge: 0, no discharge; 1, clear thin discharge; 2, thick purulent discharge; edema: 0, no edema; 1, mild edema; 2, severe edema; crusting: 0, no crusting; 1, mild crusting; 2, severe crusting; scarring: 0, no scarring; 1, mild scarring; 2, severe scarring). Each side was graded separately, and the scores from both sides were added to determine the overall scores for a particular domain. The total endoscopy score was calculated based on the sum of scores of these endoscopic domains. Endoscopic scores were also recorded before ESS (baseline) and at 1-, 3-, 6- and 12-month follow-up visits. Total endoscopy score range: 0~22, with higher scores indicating greater severity.
- 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|