Azithromycin in the treatment of Chronic sinusitis: clinical and biopsy evaluation in a controlled study

Phase 3

Recruiting

• Conditions: Sinusitis; Paranasal sinuses; Polyp of nasal cavity; Polypoid sinus degeneration; Other polyp of sinus; Polyps; C08.460.692.752; A04.531.621; J33.0; J33.1

• Registration Number: RBR-9pqqpb
• Lead Sponsor: Hospital das Clínicas da Universidade Federal de Minas Gerais

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2017-11-16
• Last Update Posted: 29 May 2023

Recruitment & Eligibility

• Status: Recruiting
• Sex: Not specified
• Target Recruitment: Not specified

Inclusion Criteria

Patients with eosinophilic nasosinusal polyposis; above 18 years of age; with a percentage of eosinophils equal to or greater than 40% that at clinical and endoscopic examination do not present evidence of active nasosinusal infection (ex: purulent secretion in nasal fossa)

Exclusion Criteria

Patients with non-eosinophilic polyposis; younger than 18 years; such as cystic fibrosis; Kartagener's syndrome; antrochoanal polyp; eosinophilic nasosinusal polyposis in the presence of infection; and patients who used corticosteroids or antihistamines in the 15 days prior to the study .

Study & Design

• Study Type: Intervention
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Expected outcome 1: Clinical disease control and patient choice not to undergo surgery after 12 weeks of treatment. It is expected that over 60% of patients in the treated group will choose not to undergo surgery.;Expected outcome 2: Improvement of the clinical response of the patient using the Visual Analogue Scale (VAS) observing a reduction of the test score of at least 3 points, evaluated at the first visit and after 12 weeks of treatment.;Expected outcome 3: Improved clinical control of the disease using the Quality of Life Questionnaire (SNOT-22), considering a reduction of at least 14 points, evaluated at the first visit and after 12 weeks. A reduction above 14 points is expected in at least 60% of patients in the treated group;Expected outcome 4: Improvement in endoscopic evaluation of the patient, using Polyposis staging, with reduction of polyp size, evaluated at the first visit and after 12 weeks. Reduction of at least 3 points is expected in 70% of patients in the treatment group.

Secondary Outcome Measures

Name	Time	Method
Quantification of the cellularity and the apoptosis index of the biopsied samples will be performed comparing values in the pre and post treatment, being performed in the samples of the first biopsy (first consultation) and after 12 weeks (second biopsy). The treatment group is expected to reduce the percentage of eosinophils by at least 6%