chronic sinusitis
Conditions
Interventions
40 participants will be recruited for the study. All participants will be submitted to two types of interventions of 3 months with interval of 2 weeks between them (wash-out period). Randomization wil
Since the vials may contain a placebo or corticosteroid solution (budesonide), so that while bottle 1 is placebo, bottle 2 will have medication and vice versa.
In addition, participants will be monito
Drug
Device
E05.927.573.500
Sponsors
Universidade Federal de São Paulo - UNIFESP
Universidade Federal de São Paulo - UNIFESP
Eligibility
Age
18 Years to 100 Years
Inclusion criteria
Inclusion criteria: Older than 18 years; chronic rhinosinusitis with nasosinusal polyposis; endoscopic nasosinusal surgery for at least 6 months; partially controlled or uncontrolled using corticosteroid nasal spray.
Exclusion criteria
Exclusion criteria: Refusal to participate in the study or to sign the ICF; inability to answer the questionnaires of the present study; pregnant or nursing mothers; absolute contraindication to EC use; prior diagnosis of immunodeficiencies; previous diagnosis of nasosinusal neoplasias; previous diagnosis of primary ciliary dyskinesias; previous diagnosis of cystic fibrosis; use, within 30 days prior to inclusion in the study, of oral, intramuscular or intravenous EC; use, during the study period, of oral, intramuscular or intravenous EC; nasal endoscopy evidencing an important block of the middle meatus (or nasal cavity) by polyp, edema or synechia, which does not permit visualization of the sinuses operated.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Within each intervention, the following parameters will be compared in the initial period, 1 month and 3 months: SNOT-22 questionnaire, disease control, Lund-Kennedy endoscopic score and subjective evaluation of improvement / worsening. An improvement of all parameters evaluated in the period in which nasal irrigation with corticosteroids is used is expected. | — |
Secondary
| Measure | Time frame |
|---|---|
| Among the interventions, there will be a comparison of each specific evaluation period; SNOT-22; disease control; Lund-Kennedy endoscopic score; subjective evaluation of improvement / worsening; subjective assessment of the need for surgery; number of exacerbations of rhinosinusitis. An improvement of all parameters evaluated in the period in which nasal irrigation with corticosteroids is used is expected. | — |
Countries
Brazil
Contacts
Public ContactErika Marchetti
Universidade Federal de São Paulo - UNIFESP
Outcome results
None listed