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Efficacy of Macrolide and Glucocorticoid in the Treatment of Chronic Rhinosinusitis Patients After Endoscopic Sinus Surgery ( ESS)

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ClinicalTrials.gov Identifier: NCT02182492
Recruitment Status : Completed
First Posted : July 8, 2014
Last Update Posted : October 11, 2016
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

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

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

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




Primary Outcome Measures :
  1. Change of subjective symptoms visual analog scores [ 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.


Secondary Outcome Measures :
  1. Change of nasal endoscopic scores [ 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.


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
Last Update Posted: October 11, 2016
Last Verified: October 2016

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