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

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ClinicalTrials.gov Identifier: NCT02182492
Recruitment Status : Completed
First Posted : July 8, 2014
Results First Posted : September 25, 2018
Last Update Posted : September 25, 2018
Sponsor:
Collaborator:
National Natural Science Foundation of China
Information provided by (Responsible Party):
Zheng Liu, Huazhong University of Science and Technology

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.


Condition or disease Intervention/treatment Phase
Chronic Rhinosinusitis Endoscopic Sinus Surgery Drug: Clarithromycin Drug: Glucocorticoid Not Applicable

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 187 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Comparison of Different Efficacy of Macrolide and Glucocorticoid in the Treatment of Chronic Rhinosinusitis Patients After Endoscopic Sinus Surgery
Study Start Date : January 2014
Actual Primary Completion Date : December 2015
Actual Study Completion Date : June 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Endoscopy Steroids

Arm Intervention/treatment
Experimental: Glucocorticoid
Fluticasone propionate nasal spray
Drug: Glucocorticoid
Fluticasone propionate nasal spray 200 μg/d for 3 months
Other Name: FLIXONASE

Experimental: Clarithromycin
Clarithromycin tablet
Drug: Clarithromycin
Clarithromycin 250 mg tablet once daily for 3 months
Other Name: KLACID




Primary Outcome Measures :
  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 Outcome Measures :
  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 Outcome Measures:
  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. ]


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Ages Eligible for Study:   16 Years to 70 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02182492


Locations
China, Hubei
Department of ENT, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, China, 430030
Sponsors and Collaborators
Zheng Liu
National Natural Science Foundation of China
Investigators
Study Director: 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

Responsible Party: Zheng Liu, Professor of Otolaryngology-Head & Neck Surgery Vice Director Department of ENT Tongji Hospital Tongji Medical College Huazhong University of Science and Technology, Huazhong University of Science and Technology
ClinicalTrials.gov Identifier: NCT02182492     History of Changes
Other Study ID Numbers: ENTDrug-001
First Posted: July 8, 2014    Key Record Dates
Results First Posted: September 25, 2018
Last Update Posted: September 25, 2018
Last Verified: September 2018

Additional relevant MeSH terms:
Sinusitis
Paranasal Sinus Diseases
Nose Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Otorhinolaryngologic Diseases
Fluticasone
Clarithromycin
Glucocorticoids
Anti-Inflammatory Agents
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Dermatologic Agents
Anti-Allergic Agents
Anti-Bacterial Agents
Anti-Infective Agents
Protein Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Cytochrome P-450 CYP3A Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists