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

NCT ID: NCT02182492

Last Updated: 2018-09-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 187 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-01-31
• Study Completion Date: 2016-06-30

Brief 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.

Detailed 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.

Conditions

Chronic Rhinosinusitis; Endoscopic Sinus Surgery

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Glucocorticoid

Fluticasone propionate nasal spray

Group Type: EXPERIMENTAL

Glucocorticoid

Intervention Type: DRUG

Fluticasone propionate nasal spray 200 μg/d for 3 months

Clarithromycin

Clarithromycin tablet

Group Type: EXPERIMENTAL

Clarithromycin

Intervention Type: DRUG

Clarithromycin 250 mg tablet once daily for 3 months

Interventions

Clarithromycin

Clarithromycin 250 mg tablet once daily for 3 months

Intervention Type: DRUG

Glucocorticoid

Fluticasone propionate nasal spray 200 μg/d for 3 months

Intervention Type: DRUG

Other Intervention Names

KLACID; FLIXONASE

Eligibility 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

• Minimum Eligible Age: 16 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Natural Science Foundation of China

OTHER_GOV

Sponsor Role: collaborator

Zheng Liu

OTHER

Sponsor Role: lead

Responsible Party

Zheng Liu

Professor of Otolaryngology-Head & Neck Surgery Vice Director Department of ENT Tongji Hospital Tongji Medical College Huazhong University of Science and Technology

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Zheng Liu, Doctor

Role: STUDY_DIRECTOR

Professor of Otolaryngology-Head & Neck Surgery Vice Director Department of ENT Tongji Hospital Tongji Medical College Huazhong University of Science and Technology

Locations

Department of ENT, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology

Wuhan, Hubei, China

Countries

China

Other Identifiers

ENTDrug-001

Identifier Type: -

Identifier Source: org_study_id