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

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

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.

Study Overview

• Status: Completed
• Conditions: Chronic Rhinosinusitis; Endoscopic Sinus Surgery
• Intervention / Treatment: Drug: Glucocorticoid; Drug: Clarithromycin

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.

• Study Type: Interventional
• Enrollment (Actual): 187
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Hubei
    • Wuhan, Hubei, China, 430030
      • Department of ENT, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 70 years (ADULT, OLDER_ADULT, CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Glucocorticoid; Fluticasone propionate nasal spray	Drug: Glucocorticoid; Fluticasone propionate nasal spray 200 μg/d for 3 months; Other Names: FLIXONASE
EXPERIMENTAL: Clarithromycin; Clarithromycin tablet	Drug: Clarithromycin; Clarithromycin 250 mg tablet once daily for 3 months; Other Names: KLACID

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Total Nasal Endoscopic Scores	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.	Scores will be recorded just before ESS and at 1-, 3-, 6- and 12-month follow-up visit.

Other Outcome Measures

Outcome Measure	Time Frame
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.

Collaborators and Investigators

• Sponsor: Zheng Liu
• Collaborators: National Natural Science Foundation of China
• Investigators: 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

Study record dates

Study Major Dates

• Study Start: January 1, 2014
• Primary Completion (ACTUAL): December 1, 2015
• Study Completion (ACTUAL): June 1, 2016

Study Registration Dates

• First Submitted: June 30, 2014
• First Submitted That Met QC Criteria: July 7, 2014
• First Posted (ESTIMATE): July 8, 2014

Study Record Updates

• Last Update Posted (ACTUAL): September 25, 2018
• Last Update Submitted That Met QC Criteria: September 21, 2018
• Last Verified: September 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Otorhinolaryngologic Diseases; Paranasal Sinus Diseases; Nose Diseases; Sinusitis; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Enzyme Inhibitors; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Anti-Bacterial Agents; Cytochrome P-450 CYP3A Inhibitors; Cytochrome P-450 Enzyme Inhibitors; Protein Synthesis Inhibitors; Clarithromycin; Glucocorticoids
• Other Study ID Numbers: ENTDrug-001