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

Zheng Liu

Status

Completed

Conditions

Chronic Rhinosinusitis

Endoscopic Sinus Surgery

Treatments

Drug: Clarithromycin

Drug: Glucocorticoid

Study type

Interventional

Funder types

Other

Identifiers

NCT02182492

ENTDrug-001

Details and patient eligibility

About

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.

Full description

Chronic rhinosinusitis (CRS) is a multifactorial inflammatory disorder that causes various symptoms including nasal obstruction, rhinorrhea, olfactory dysfunction, facial pain, and headache . Endoscopic sinus surgery (ESS) is usually recommended for patients who do not response well to conservative treatments. Although surgery is effective to alleviate symptoms and improve the quality of life of CRS patients, a followed long-term postoperative medical treatment is indispensable. Current European and American guidelines recommend glucocorticoids and antibiotics as the primary pharmacotherapeutic approaches for CRS before and after ESS. However, there are a number of CRS patients not responding well to glucocorticoid treatment and conflicting results exist regarding the efficacy of long-term, low-dose macrolide treatment. One potential reason is that CRS is a heterogeneous group of disorders unified by similar clinical presentations and its phenotypes and/or endotypes may be important factors determining the efficacy of treatments.

Enrollment

187 patients

Sex

All

Ages

16 to 70 years old

Volunteers

No Healthy Volunteers

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