se of Botulinum Toxin for Treatment of Idiopathic Rhinitis

Not Applicable

• Conditions: idiopathic rhinitis; C08.460.799

• Registration Number: RBR-4jbw4s
• Lead Sponsor: Faculdade de Medicina da Universidade de São Paulo

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-07-23
• Last Update Posted: 29 May 2023

Recruitment & Eligibility

• Status: Data analysis completed
• Sex: Not specified
• Target Recruitment: Not specified

Inclusion Criteria

Criteria for inclusion in the study: Patients older than 18 years who signed the informed consent form and understood the explanation of the study, carried out by the researcher himself. Patients of both sexes, without distinction of race. Patients diagnosed for idiopathic rhinitis for at least one year, ie patients in whom the other etiologies of rhinitis (allergic rhinitis, non-allergic, drug, hormonal, drug and occupational eosinophilic rhinitis) were excluded from the clinical history , physical examination, nasal cytology examination with eosinophils below 2%, and immediate hypersensitivity skin test for negative inhalants.

Exclusion Criteria

Exclusion criteria in the study: Patients with other nasal anatomical abnormalities, such as nasosinusal polyposis or obstructive nasal septum deviation. Patients with acute or chronic rhinosinusitis. Patients with severe systemic diseases, glaucoma or prostatic hypertrophy that may be aggravated by anticholinergic therapy. Patients with immediate hypersensitivity skin test for positive inhalants, nasal cytological examination with eosinophilia greater than 2%.Patients who received rhinitis medications prior to the immediate inhalant hypersensitivity skin test. Patients pregnant or likely to be pregnant.

Study & Design

• Study Type: Intervention
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The aim of this study is to analyze the effects of intranasal injection of BTX-A in the control of symptoms of idiopathic rhinitis, ;Improvement of rhinitis symptoms in individuals, at least 25%, assessed by a symptom score, measurement of nasal inspiratory peak flow, acoustic rhinometry and visual analog scale (VAS). Data collected in the first, second, fourth, eighth and twelfth weeks after the intervention.

Secondary Outcome Measures

Name	Time	Method
More marked improvement in the symptoms of runny nose and nasal obstruction, already in the first week after the intervention, persisting until the twelfth week.;Evaluate possible adverse effects.