Use of Budesonide Diluted to Maximum Clinical Treatment of Patients With Chronic Rhinosinusitis With Polyoposis.

NCT05541419 | Unknown DMC

• 1 other identifier: MFornazieri
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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).

Conditions

Chronic Rhinosinusitis (Diagnosis)

Keywords

Rhinosinusitis; Quality of life

Outcome Measures

Primary Outcomes (1)

• Evaluate the improvement in the Nasal Polyp Score

  To verify, from the change in the Nasal Polyp Score (NPS, range from 0 to 8, higher score indicates larger polyp size), the impact of maximum clinical treatment - intramuscular injection of Dispropan in intramuscular injectable suspension and budesonide in nasal spray, two sprays of 50 mcg in each nostril - plus high-volume diluted budesonide nasal lavage, compared to the same maximum clinical treatment plus high-flow placebo nasal lavage in patients with chronic rhinosinusitis with polyposis without previous nasal surgery for a period of 16 weeks.

  16 weeks

Secondary Outcomes (3)

• Improves olfactory ability through the University of Pennsylvania Smell Identification Test

  16 weeks

• Sino-Nasal Outcome Test - 22 (SNOT-22)

  16 weeks

• Analogic visual scale (VAS)

  16 weeks

Study Arms (2)

Maximum clinical treatment + Budesonide diluted

EXPERIMENTAL

The maximum clinical treatment consists of intramuscular injection of Dispropan® in intramuscular injectable suspension and busonid in nasal spray, two sprays of 50mcg in each nostril. In this study, the investigator wishes to add to the maximum clinical treatment a daily wash with high volume diluted budesonide.

Drug: Budesonide Nasal

Maximum clinical treatment + Placebo

PLACEBO COMPARATOR

To compare the efficacy of adding diluted budesonide lavage to maximal clinical treatment, the placebo group is used. The placebo formula is composed of 1% glycerin diluted in water.

Drug: Placebos

Interventions

Budesonide Nasal DRUG

The patient performed a lavage once daily with 2mg dilute budesonide. The maximum clinical treatment consists of intramuscular injection of Dispropan® in intramuscular injectable suspension and busonid in nasal spray, two sprays of 50mcg in each nostril.

Also known as: Busonid

Maximum clinical treatment + Budesonide diluted

Placebos DRUG

Composed of 1% glycerin diluted in water. The maximum clinical treatment consists of intramuscular injection of Dispropan® in intramuscular injectable suspension and busonid in nasal spray, two sprays of 50mcg in each nostril.

Also known as: placebo effect

Maximum clinical treatment + Placebo

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• A minimum nasal polyp score (NPS) of 5 of a maximum of 8 for both nostrils (with at least a score of 2 for each nostril).
• Presence of at least two of the following symptoms prior to screening: nasal blockage / obstruction / congestion or rhinorrhea (anterior or posterior); facial / pressure pain; reduction or loss of smell.

You may not qualify if:

• A patient under the age of 18, or over 55;
• SNOT-22 with sum of less than 7;
• Patients who have used drugs or therapies that interfere with the results of this clinical trial within 2 months prior to screening: treatment with immunosuppressants; anti-immunoglobulin and within two months prior to screening.
• Initiation of allergen immunotherapy within 3 months prior to first consultation or plan to initiate therapy during the screening period or randomized treatment period;
• Patients who underwent any nasal surgery;
• Patients on anti-leukotrienes and antihistamines
• Asthmatic patients will be excluded if: forced expiratory volume (FEV1) is 60% predicted or lower; an exacerbation requiring systemic (oral and / or parenteral) or hospitalization for more than 24 hours for the treatment of asthma has occurred within 3 months prior to screening; use of a dose greater than 1000 μg of inhaled fluticasone or equivalent;
• Patients with a short life expectancy (less than 6 months);

Sponsors & Collaborators

• Universidade Estadual de Londrina: lead

Study Sites (1)

Marco Aurelio Fornazieri

Londrina, Paraná, 86010-160, Brazil

RECRUITING

MeSH Terms

Conditions

Disease; Rhinosinusitis

Interventions

Placebo Effect

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Rhinitis; Respiratory Tract Infections; Infections; Sinusitis; Paranasal Sinus Diseases; Nose Diseases; Respiratory Tract Diseases; Otorhinolaryngologic Diseases

Intervention Hierarchy (Ancestors)

Effect Modifier, Epidemiologic; Epidemiologic Factors; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Central Study Contacts

Marco Aurélio Fornazieri

CONTACT

+55 43 99813-3812; marcofornazieri@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: This is a double-blind study.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: August 24, 2022
• First Posted: September 15, 2022
• Study Start: August 10, 2018
• Primary Completion: August 25, 2022
• Study Completion: August 10, 2025
• Last Updated: September 15, 2022

Record last verified: 2022-09

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)