Using Budesonide for Chronic Rhinosinusitis with Polyps

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

This study tests if using a nasal rinse with budesonide can help people with chronic rhinosinusitis and nasal polyps feel better compared to a placebo over 16 weeks.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 60 (estimated)
• Ages: 18 Years to 55 Years
• Sex: All
• Sponsor: Universidade Estadual de Londrina (Academic / other)
• Drugs / interventions: immunotherapy
• Locations: 1 site (Londrina, Paraná)
• Trial ID: NCT05541419 on ClinicalTrials.gov

What this trial studies

This clinical trial investigates the effectiveness of nasal lavage with budesonide, a corticosteroid, in patients suffering from chronic rhinosinusitis with polyposis. It employs a double-blind, randomized design with two groups of 30 patients each, comparing the effects of budesonide against a placebo over a 16-week period. The study will assess various outcomes, including nasal polyp scores, quality of life measures, and nasal airflow metrics, to determine the impact of the treatment on symptoms and overall health. The goal is to optimize therapy for this condition, which often leads to surgical interventions if not adequately managed.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 to 55 with a nasal polyp score of 5 or higher and experiencing specific symptoms of chronic rhinosinusitis.

Not a fit: Patients under 18 or over 55, those with low symptom scores, or those who have recently undergone nasal surgery will not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly improve the quality of life for patients with chronic rhinosinusitis by reducing symptoms and the need for surgery.

How similar studies have performed: While the approach of using high-volume nasal lavage is gaining interest, the specific combination of budesonide in this manner is relatively novel and has not been extensively tested in prior studies.

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);

Where this trial is running

Londrina, Paraná

• Marco Aurelio Fornazieri — Londrina, Paraná, Brazil (Recruiting)

Study contacts

• Study coordinator: Marco Aurélio Fornazieri

Conditions Chronic Rhinosinusitis; Rhinosinusitis; Quality of life