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

NCT ID: NCT05541419

Last Updated: 2022-09-15

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-08-10
• Study Completion Date: 2025-08-10

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.

Conditions

Chronic Rhinosinusitis (Diagnosis)

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Maximum clinical treatment + Budesonide diluted

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.

Group Type: EXPERIMENTAL

Budesonide Nasal

Intervention Type: 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.

Maximum clinical treatment + Placebo

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.

Group Type: PLACEBO_COMPARATOR

Placebos

Intervention Type: 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.

Interventions

Budesonide Nasal

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.

Intervention Type: DRUG

Placebos

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.

Intervention Type: DRUG

Other Intervention Names

Busonid; placebo effect

Eligibility Criteria

Inclusion Criteria

1. 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).

2. 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.

Exclusion Criteria

1. A patient under the age of 18, or over 55;

2. SNOT-22 with sum of less than 7;

3. 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.

4. Initiation of allergen immunotherapy within 3 months prior to first consultation or plan to initiate therapy during the screening period or randomized treatment period;

5. Patients who underwent any nasal surgery;

6. Patients on anti-leukotrienes and antihistamines

7. 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;

8. Patients with a short life expectancy (less than 6 months);

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Universidade Estadual de Londrina

OTHER

Sponsor Role: lead

Responsible Party

Marco Aurélio Fornazieri

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Marco Aurelio Fornazieri

Londrina, Paraná, Brazil

Site Status: RECRUITING

Countries

Brazil

Central Contacts

Marco Aurélio Fornazieri

Role: CONTACT

marcofornazieri@gmail.com

+55 43 99813-3812

Facility Contacts

Marco A Fornazieri

Role: primary

marcofornazieri@gmail.com

4330291436

Other Identifiers

MFornazieri

Identifier Type: -

Identifier Source: org_study_id