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

Launched by UNIVERSIDADE ESTADUAL DE LONDRINA · Sep 12, 2022

Keywords

ClinConnect Summary

This clinical trial is studying the effects of a medication called budesonide on patients with chronic rhinosinusitis with polyps, a condition that causes long-lasting nasal congestion and other symptoms. The trial is designed to compare how well budesonide works when mixed with a large volume of liquid against a placebo (a treatment that looks like the real medication but doesn’t contain any active ingredients) over 16 weeks. Researchers will assess improvements in symptoms and quality of life through various tests, including surveys about nasal symptoms and smell.

To participate, individuals must be between 18 and 55 years old and have a specific level of nasal polyps and symptoms like nasal blockage or loss of smell. Participants will be randomly assigned to receive either the budesonide treatment or the placebo. It's important to note that certain conditions or recent treatments may exclude someone from participating, such as recent nasal surgery or specific asthma-related issues. If you're interested in learning more or think you might qualify, please reach out to the research team for details.

Gender

ALL

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);