Back to resultsEfficacy of Macrolide and Glucocorticoid in the Treatment of Chronic Rhinosinusitis After Endoscopic Sinus Surgery
Primary Purpose
Chronic Rhinosinusitis, Endoscopic Sinus Surgery
Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Clarithromycin
Glucocorticoid
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Rhinosinusitis
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
Sites / Locations
- Department of ENT, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Glucocorticoid
Clarithromycin
Arm Description
Fluticasone propionate nasal spray
Clarithromycin tablet
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
Full Information
NCT ID
NCT02182492
First Posted
June 30, 2014
Last Updated
September 21, 2018
Sponsor
Zheng Liu
Collaborators
National Natural Science Foundation of China
1. Study Identification
Unique Protocol Identification Number
NCT02182492
Brief Title
Efficacy of Macrolide and Glucocorticoid in the Treatment of Chronic Rhinosinusitis After Endoscopic Sinus Surgery
Official Title
Comparison of Different Efficacy of Macrolide and Glucocorticoid in the Treatment of Chronic Rhinosinusitis Patients After Endoscopic Sinus Surgery
Study Type
Interventional
2. Study Status
Record Verification Date
September 2018
Overall Recruitment Status
Completed
Study Start Date
January 2014 (undefined)
Primary Completion Date
December 2015 (Actual)
Study Completion Date
June 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Zheng Liu
Collaborators
National Natural Science Foundation of China
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Rhinosinusitis, Endoscopic Sinus Surgery
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
187 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Glucocorticoid
Arm Type
Experimental
Arm Description
Fluticasone propionate nasal spray
Arm Title
Clarithromycin
Arm Type
Experimental
Arm Description
Clarithromycin tablet
Intervention Type
Drug
Intervention Name(s)
Clarithromycin
Other Intervention Name(s)
KLACID
Intervention Description
Clarithromycin 250 mg tablet once daily for 3 months
Intervention Type
Drug
Intervention Name(s)
Glucocorticoid
Other Intervention Name(s)
FLIXONASE
Intervention Description
Fluticasone propionate nasal spray 200 μg/d for 3 months
Primary Outcome Measure Information:
Title
Total Subjective Symptoms Visual Analog Scores (VAS)
Description
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.
Time Frame
Scores will be recorded just before ESS and at 1-, 3-, 6- and 12-month follow-up visit.
Secondary Outcome Measure Information:
Title
Total Nasal Endoscopic Scores
Description
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.
Time Frame
Scores will be recorded just before ESS and at 1-, 3-, 6- and 12-month follow-up visit.
Other Pre-specified Outcome Measures:
Title
Measurement of Protein Levels of Inflammatory Molecules in Tissues
Time Frame
Polyp tissues from CRSwNP patients and diseased sinus mucosa from CRSsNP patients will be collected during surgery.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
16 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Zheng Liu, Doctor
Organizational Affiliation
Professor of Otolaryngology-Head & Neck Surgery Vice Director Department of ENT Tongji Hospital Tongji Medical College Huazhong University of Science and Technology
Official's Role
Study Director
Facility Information:
Facility Name
Department of ENT, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
City
Wuhan
State/Province
Hubei
ZIP/Postal Code
430030
Country
China
12. IPD Sharing Statement
Learn more about this trial
Efficacy of Macrolide and Glucocorticoid in the Treatment of Chronic Rhinosinusitis After Endoscopic Sinus Surgery
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