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

NCT02182492 | Completed Results DMC

• 1 other identifier: ENTDrug-001
• Study Type: interventional
• Target: 187
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Rhinosinusitis; Endoscopic Sinus Surgery

Outcome Measures

Primary Outcomes (1)

• Total Subjective Symptoms Visual Analog Scores (VAS)

  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.

  Scores will be recorded just before ESS and at 1-, 3-, 6- and 12-month follow-up visit.

Secondary Outcomes (1)

• Total Nasal Endoscopic Scores

  Scores will be recorded just before ESS and at 1-, 3-, 6- and 12-month follow-up visit.

Other Outcomes (1)

• Measurement of Protein Levels of Inflammatory Molecules in Tissues

  Polyp tissues from CRSwNP patients and diseased sinus mucosa from CRSsNP patients will be collected during surgery.

Study Arms (2)

Glucocorticoid

EXPERIMENTAL

Fluticasone propionate nasal spray

Drug: Glucocorticoid

Clarithromycin

EXPERIMENTAL

Clarithromycin tablet

Drug: Clarithromycin

Interventions

Clarithromycin DRUG

Clarithromycin 250 mg tablet once daily for 3 months

Also known as: KLACID

Clarithromycin

Glucocorticoid DRUG

Fluticasone propionate nasal spray 200 μg/d for 3 months

Also known as: FLIXONASE

Glucocorticoid

Eligibility Criteria

• Age: 16 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Zheng Liu: lead
• National Natural Science Foundation of China: collaborator

Study Sites (1)

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

Wuhan, Hubei, 430030, China

Location

MeSH Terms

Interventions

Clarithromycin; Glucocorticoids; Fluticasone

Intervention Hierarchy (Ancestors)

Erythromycin; Macrolides; Polyketides; Lactones; Organic Chemicals; Adrenal Cortex Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Physiological Effects of Drugs; Pharmacologic Actions; Chemical Actions and Uses; Androstadienes; Androstenes; Androstanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Results Point of Contact

• Title: Dr. Zheng Liu
• Organization: Department of ENT of Tongji Hospital Tongji Medical College Huazhong University of Science and Technology

zhengliuent@hotmail.com

86 027 83663807

Study Officials

• 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

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor of Otolaryngology-Head & Neck Surgery Vice Director Department of ENT Tongji Hospital Tongji Medical College Huazhong University of Science and Technology

Study Record Dates

• First Submitted: June 30, 2014
• First Posted: July 8, 2014
• Study Start: January 1, 2014
• Primary Completion: December 1, 2015
• Study Completion: June 1, 2016
• Last Updated: September 25, 2018
• Results First Posted: September 25, 2018

Record last verified: 2018-09

Locations

CN (1)