Clinical trial NCT02182492: 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
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Rhinosinusitis
Endoscopic Sinus Surgery
Lead sponsor: Huazhong University of Science and Technology
Sponsor class: OTHER
Collaborators: name: National Natural Science Foundation of China
First posted: 2014-07-08
Enrollment: 187
Sex: ALL
Minimum age (years): 16
Maximum age (years): 70
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Total Subjective Symptoms Visual Analog Scores (VAS)
timeFrame: Scores will be recorded just before ESS and at 1-, 3-, 6- and 12-month follow-up visit.
Secondary outcomes:
measure: Total Nasal Endoscopic Scores
timeFrame: Scores will be recorded just before ESS and at 1-, 3-, 6- and 12-month follow-up visit.
Other outcomes:
measure: Measurement of Protein Levels of Inflammatory Molecules in Tissues
timeFrame: Polyp tissues from CRSwNP patients and diseased sinus mucosa from CRSsNP patients will be collected during surgery.
Locations:
city: Wuhan
country: China
facility: Department of ENT, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
state: Hubei
Study officials:
affiliation: Professor of Otolaryngology-Head & Neck Surgery Vice Director Department of ENT Tongji Hospital Tongji Medical College Huazhong University of Science and Technology
name: Zheng Liu, Doctor
role: STUDY_DIRECTOR
References: