Sinusitis
Conditions
Interventions
Experimental group: 35 patients with eosinophilic nasosinusal polyposis, older than 18 years, with a percentage of eosinophils equal to or greater than 40% who at clinical and endoscopic examination d
Drug
Sponsors
Hospital das Clínicas da Universidade Federal de Minas Gerais
Hospital das Clínicas da Universidade Federal de Minas Gerais
Eligibility
Age
18 Years to 70 Years
Inclusion criteria
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
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 .
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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% | — |
Countries
Brazil
Contacts
Public ContactIsamara Simas de Oliveira
Hospital das Clínicas da Universidade Federal de Minas Gerais
Outcome results
None listed