N/A
Completed N=187
Efficacy of Macrolide and Glucocorticoid in the Treatment of Chronic Rhinosinusitis After Endoscopic Sinus Surgery
chronic rhinosinusitis · Endoscopic Sinus Surgery
Source: ClinicalTrials.gov NCT02182492 ↗
Enrolled (actual)
187
Serious AEs
0.0%
Results posted
Sep 2018
Primary outcomePrimary: Total Subjective Symptoms Visual Analog Scores (VAS) — 20.4; 20.7; 9.7; 8.9 score on a scale
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Total Subjective Symptoms Visual Analog Scores (VAS) |
20.4; 20.7; 9.7; 8.9; 7.0; 5.8 | — |
| SECONDARY Total Nasal Endoscopic Scores |
8.2; 7.6; 5.3; 4.7; 3.7; 3 | — |
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
Data sourced from ClinicalTrials.gov (NCT02182492). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.