Efficacy of Macrolide and Glucocorticoid in the Treatment of Chronic Rhinosinusitis After Endoscopic Sinus Surgery

• Status: Completed
• Trial end date: 2016-06-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Zheng Liu
• Collaborator: National Natural Science Foundation of China
• Treatments: Clarithromycin; Fluticasone; Glucocorticoids

Criteria

Inclusion Criteria:

• Meeting the CRS diagnostic criteria including CRSsNP and CRSwNP based on the EP3OS definition

• Age ≥16 and ≤70 years

• Chinese of either sex

• Failure to conventional medical therapies according to EP3OS recommendation

Exclusion Criteria:

• Pregnant or breast-feeding women

• Cystic fibrosis

• Congenital ciliary dyskinesia

• Sinonasal fungal disease

• Systemic vasculitis

• Granulomatous disease

• Tumor

• Immunodeficiency

• Allergic to clarithromycin or topical corticosteroid

• With an upper respiratory tract infection within 4 weeks of entering the study

• With serious metabolic, cardiovascular, autoimmune, neurology, blood, digestive, cerebrovascular, respiratory system disease, or any disease interfering with the evaluation of results or affecting subjects' safety such as glaucoma and tuberculosis

• With emotional or mental problems

• Have received immunotherapy within the previous 3 months

• Have had a history of local or systemic medications, such as glucocorticoids and macrolides within 4 weeks

• Have had an acute asthmatic within the 4 weeks before entering the study