Trial · NCT02182492
Efficacy of Macrolide and Glucocorticoid in the Treatment of Chronic Rhinosinusitis After Endoscopic Sinus Surgery
NCT02182492, Not applicable, Completed, Zheng Liu; results first posted 2018-09-25
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Efficacy of Macrolide and Glucocorticoid in the Treatment of Chronic Rhinosinusitis After Endoscopic Sinus Surgery. Trials, record NCT02182492. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02182492
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Efficacy of Macrolide and Glucocorticoid in the Treatment of Chronic Rhinosinusitis After Endoscopic Sinus Surgery
- NCT number
- NCT02182492
- Status
- Completed
- Phases
- Not applicable
- Enrollment
- 187 participants, actual
- Lead sponsor
- Zheng Liu
- Conditions
- Chronic Rhinosinusitis, Endoscopic Sinus Surgery
- Interventions
- Clarithromycin, Glucocorticoid
- First posted
- 2014-07-08
- Last updated
- 2018-09-25
- Results first posted
- 2018-09-25
Source ClinicalTrials.gov
Registered outcomes3
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Total Subjective Symptoms Visual Analog Scores (VAS) | Scores will be recorded just before ESS and at 1-, 3-, 6- and 12-month follow-up visit. | 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 | Total Nasal Endoscopic Scores | Scores will be recorded just before ESS and at 1-, 3-, 6- and 12-month follow-up visit. | 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. |
| Other | 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. |
Source ClinicalTrials.gov
Outcomes3
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Total Subjective Symptoms Visual Analog Scores (VAS) | Scores will be recorded just before ESS and at 1-, 3-, 6- and 12-month follow-up visit. | 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. | score on a scale | MEAN |
| SECONDARY | Total Nasal Endoscopic Scores | Scores will be recorded just before ESS and at 1-, 3-, 6- and 12-month follow-up visit. | 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. | score on a scale | MEAN |
| OTHER_PRE_SPECIFIED | 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. |
Source ClinicalTrials.gov
Results by group20
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Total Subjective Symptoms Visual Analog Scores (VAS) | Glucocorticoid | Baseline | 20.4 | Standard Deviation 8.1 | score on a scale |
| Total Subjective Symptoms Visual Analog Scores (VAS) | Clarithromycin | Baseline | 20.7 | Standard Deviation 7.8 | score on a scale |
| Total Subjective Symptoms Visual Analog Scores (VAS) | Glucocorticoid | 1-month | 9.7 | Standard Deviation 5.2 | score on a scale |
| Total Subjective Symptoms Visual Analog Scores (VAS) | Clarithromycin | 1-month | 8.9 | Standard Deviation 5.0 | score on a scale |
| Total Subjective Symptoms Visual Analog Scores (VAS) | Glucocorticoid | 3-month | 7.0 | Standard Deviation 4.2 | score on a scale |
| Total Subjective Symptoms Visual Analog Scores (VAS) | Clarithromycin | 3-month | 5.8 | Standard Deviation 4.3 | score on a scale |
| Total Subjective Symptoms Visual Analog Scores (VAS) | Glucocorticoid | 6-month | 5.9 | Standard Deviation 4.5 | score on a scale |
| Total Subjective Symptoms Visual Analog Scores (VAS) | Clarithromycin | 6-month | 4.7 | Standard Deviation 4.2 | score on a scale |
| Total Subjective Symptoms Visual Analog Scores (VAS) | Glucocorticoid | 12-month | 5.6 | Standard Deviation 5.3 | score on a scale |
| Total Subjective Symptoms Visual Analog Scores (VAS) | Clarithromycin | 12-month | 4.8 | Standard Deviation 5.0 | score on a scale |
1 to 10 of 20Source ClinicalTrials.gov
See all 20 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Glucocorticoid | 93 | |
| Overall Study | STARTED | Clarithromycin | 94 | |
| Overall Study | COMPLETED | Glucocorticoid | 86 | |
| Overall Study | COMPLETED | Clarithromycin | 86 | |
| Overall Study | NOT COMPLETED | Glucocorticoid | 7 | |
| Overall Study | NOT COMPLETED | Clarithromycin | 8 |
Source ClinicalTrials.gov
Adverse events6
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Mild nasal bleeding | Surgical and medical procedures | Glucocorticoid | 3 | 93 | |
| other | Mild nasal bleeding | Surgical and medical procedures | Clarithromycin | 2 | 94 | |
| other | Mild diarrhea | Surgical and medical procedures | Glucocorticoid | 1 | 93 | |
| other | Mild diarrhea | Surgical and medical procedures | Clarithromycin | 2 | 94 | |
| other | Headache | Surgical and medical procedures | Glucocorticoid | 1 | 93 | |
| other | Headache | Surgical and medical procedures | Clarithromycin | 1 | 94 |
Source ClinicalTrials.gov
Adverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Glucocorticoid | ||
| Total, all-cause mortality | Clarithromycin | ||
| Total, other adverse events | Glucocorticoid | 5 | 93 |
| Total, other adverse events | Clarithromycin | 5 | 94 |
| Total, serious adverse events | Glucocorticoid | 0 | 93 |
| Total, serious adverse events | Clarithromycin | 0 | 94 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| Glucocorticoid vs Clarithromycin: serious adverse events |
Source Trial comparisons
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT02182492
GET https://conductscience.org/api/trials/v1/NCT02182492/registered