Skip to main content
OpenTrials
Completed

NCT Number: NCT02182492

Efficacy of Macrolide and Glucocorticoid in the Treatment of Chronic Rhinosinusitis After Endoscopic Sinus Surgery

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Chronic Rhinosinusitis Endoscopic Sinus Surgery

Age range

16 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of ENT, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology

Wuhan, Hubei, 430030, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Clarithromycin

Drug

Clarithromycin 250 mg tablet once daily for 3 months

Other names: KLACID

glucocorticoid

Drug

Fluticasone propionate nasal spray 200 μg/d for 3 months

Other names: FLIXONASE

Primary outcomes

  1. Total Subjective Symptoms Visual Analog Scores (VAS)

    Time frame: 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 outcomes

  1. Total Nasal Endoscopic Scores

    Time frame: 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 outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Zheng Liu

Other

Collaborators

  • National Natural Science Foundation of China

Registry information

Official study title

Comparison of Different Efficacy of Macrolide and Glucocorticoid in the Treatment of Chronic Rhinosinusitis Patients After Endoscopic Sinus Surgery

Important dates

Study start
2014
Primary completion
2015
Study completion
2016
First posted
Jul 8, 2014
Registry last updated
Sep 25, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.