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| Name | Class |
|---|---|
| National Natural Science Foundation of China | OTHER_GOV |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Glucocorticoid | Experimental | Fluticasone propionate nasal spray |
|
| Clarithromycin | Experimental | Clarithromycin tablet |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Clarithromycin | Drug | Clarithromycin 250 mg tablet once daily for 3 months |
|
| 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. |
| 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. |
| Measure | Description | 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. |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| 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 |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of ENT, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology | Wuhan | Hubei | 430030 | China |
Patients meeting the Chronic rhinosinusitis (CRS) diagnostic criteria outlined in the European Position Paper on Rhinosinusitis and Nasal polyps (EP3OS) definition were enrolled. Three subtypes CRS included: CRS without nasal polyps (CRSsNP); non-eosinophilic CRS with nasal polyps (Non-Eos CRSwNP); eosinophilic CRS with nasal polyps (Eos CRSwNP).
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| ID | Title | Description |
|---|---|---|
| FG000 | Glucocorticoid | Fluticasone propionate nasal spray Glucocorticoid: Fluticasone propionate nasal spray 200 μg/d for 3 months |
| FG001 | Clarithromycin | Clarithromycin tablet Clarithromycin: Clarithromycin 250 mg tablet once daily for 3 months |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Glucocorticoid | Fluticasone propionate nasal spray Glucocorticoid: Fluticasone propionate nasal spray 200 μg/d for 3 months |
| BG001 | Clarithromycin | Clarithromycin tablet Clarithromycin: Clarithromycin 250 mg tablet once daily for 3 months |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | A total of 187 patients met the study eligibility criteria. Seven patients in fluticasone propionate group and 8 patients in clarithromycin group dropped out because of nonadherence. | Posted | Mean | Standard Deviation | score on a scale | Scores will be recorded just before ESS and at 1-, 3-, 6- and 12-month follow-up visit. |
|
1 year
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Glucocorticoid | Fluticasone propionate nasal spray Glucocorticoid: Fluticasone propionate nasal spray 200 μg/d for 3 months |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Mild nasal bleeding | Surgical and medical procedures | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Zheng Liu | Department of ENT of Tongji Hospital Tongji Medical College Huazhong University of Science and Technology | 86 027 83663807 | zhengliuent@hotmail.com |
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| ID | Term |
|---|---|
| D017291 | Clarithromycin |
| D005938 | Glucocorticoids |
| D000068298 | Fluticasone |
| ID | Term |
|---|---|
| D004917 | Erythromycin |
| D018942 | Macrolides |
| D061065 | Polyketides |
| D007783 | Lactones |
| D009930 |
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| Glucocorticoid | Drug | Fluticasone propionate nasal spray 200 μg/d for 3 months |
|
|
| Scores will be recorded just before ESS and at 1-, 3-, 6- and 12-month follow-up visit. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG000 | Glucocorticoid | Fluticasone propionate nasal spray Glucocorticoid: Fluticasone propionate nasal spray 200 μg/d for 3 months |
| OG001 | Clarithromycin | Clarithromycin tablet Clarithromycin: Clarithromycin 250 mg tablet once daily for 3 months |
|
|
| Secondary | 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. | A total of 187 patients met the study eligibility criteria. Seven patients in fluticasone propionate group and 8 patients in clarithromycin group dropped out because of nonadherence. | Posted | Mean | Standard Deviation | score on a scale | Scores will be recorded just before ESS and at 1-, 3-, 6- and 12-month follow-up visit. |
|
|
|
| Other Pre-specified | Measurement of Protein Levels of Inflammatory Molecules in Tissues | Not Posted | Polyp tissues from CRSwNP patients and diseased sinus mucosa from CRSsNP patients will be collected during surgery. | Participants |
| 0 |
| 93 |
| 5 |
| 93 |
| EG001 | Clarithromycin | Clarithromycin tablet Clarithromycin: Clarithromycin 250 mg tablet once daily for 3 months | 0 | 94 | 5 | 94 |
| Mild diarrhea | Surgical and medical procedures | Non-systematic Assessment |
|
| Headache | Surgical and medical procedures | Non-systematic Assessment |
|
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| Organic Chemicals |
| D000305 | Adrenal Cortex Hormones |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D045505 | Physiological Effects of Drugs |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |
| D000730 | Androstadienes |
| D000736 | Androstenes |
| D000731 | Androstanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| 3-month |
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| 6-month |
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| 12-month |
|