Ignite Creation Date:
2024-05-06 @ 6:06 PM
Last Modification Date:
2024-10-26 @ 2:41 PM
Study NCT ID:
NCT05541419
Status:
RECRUITING
Last Update Posted:
2022-09-15
First Post:
2022-08-24
Brief Title:
Use of Budesonide Diluted to Maximum Clinical Treatment of Patients With Chronic Rhinosinusitis With Polyoposis
Sponsor:
Universidade Estadual de Londrina
Organization:
Universidade Estadual de Londrina
Study Overview
Official Title:
Efficacy of Addition of High-volume Nasal Wash With Budesonide Diluted to Maximum Clinical Treatment of Patients With Chronic Rhinosinusitis With Polyoposis Double Randomized Controlled Double Study
Status:
RECRUITING
Status Verified Date:
2022-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
CRS
Brief Summary:
This is a double-blind randomized double-blind randomized double-blind randomized block design with two intervention groups of 30 patients each Patients not recruited at the otorhinolaryngology outpatient clinic of the Regional University Hospital of the North of Paraná and the University Hospital Specialties Ambulatory will be included in the study of chronic rhinosinusitis with polyposis are randomly divided with stratification for the presence of two groups of patients 30 patients with 9 asthmatics in each Of the nasal nasal with 2mg budesonide diluted in high daily volume added to the corticosteroid injectable injectable and the topic for 16 weeks compared to placebo The Polyp Score NPS Sono-Nasal Outcome Test-22 SNOT-22 University of Pennsylvania Olfactory Identification Test UPSIT peak nasal inspiratory flow PNIF visual scales preoperative tomography acoustic rhinometry computerized rhinomanometry and nasal endoscopy before and after the treatments Position Paper on Nasal Rhinosinusitis and Nasal Polyps 2012 A bilateral nasal pole score is 5 and a maximum of 8 for both nostrils with less than a score of 2 for each nostril
Detailed Description:
INTRODUTION According to the European Position Paper on Rhinosinusitis and Nasal Polyps 2012 chronic rhinosinusitis in adults can be defined as an inflammation of the nasal mucosa and paranasal sinuses lasting 12 weeks or more associated or not with nasal polyposis As to the origin of the polyps these are typically related to the eosinophilic inflammation of the upper airways and result in obstructions in different degrees of the nasal cavities Maximum clinical treatment - a combination of several classes of drugs to optimize therapy - often proves to be the first choice in the management of this disease There is however no consensus on the composition or duration of maximal clinical treatment and success rates are extremely variable If there is no improvement in the condition surgical treatment is usually instituted and if necessary supplemented with topical post-operative treatment Recent studies have led to the perception that sprays and aerosols can not adequately reach the paranasal sinuses resulting in a better effect of the medication if possible such methods should be replaced by nasal cavity lavages using high volume solutions OBJECTIVES The present study aims to compare through validated tests the impact of the inclusion of nasal lavage with budesonide diluted in high volume in relation to placebo in the improvement of the symptoms signs and quality of life of patients with chronic rhinosinusitis with polyposis If effective this therapy may decrease surgical indications and consequently health expenditures for the government METHODOLOGY Parallel randomized placebo-controlled parallel type clinical trial Patients with chronic rhinosinusitis with polyposis will be divided randomly with stratification for the presence of asthma in two groups two blocks of 30 patients 9 asthmatics each It will evaluate the effectiveness of nasal lavage with 2mg budesonide diluted in high volume daily added to the initial systemic corticosteroid injectable and the topic for 16 weeks compared to placebo EXPECTED RESULTS It is expected that diluted budesonide improvement in the symptoms signs and quality of life of patients with chronic rhinosinusitis with polyposis
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None