Study on Nasal Irrigation with Corticosteroid in patients with Chronic Sinusitis

Phase 2

Recruiting

• Conditions: chronic sinusitis; nasal polyps.; C08.460.692.752; G03.015.500.703.500

• Registration Number: RBR-9j3d9z
• Lead Sponsor: niversidade Federal de São Paulo - UNIFESP

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-09-25
• Last Update Posted: 29 May 2023

Recruitment & Eligibility

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

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

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.

Study & Design

• Study Type: Intervention
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.