Effect of nasal lavage with Budesonide diluted in large volume for the clinical treatment of patients with Chronic Rhinosinusitis with nasal polyps

Not Applicable

Recruiting

• Conditions: Chronic rhinosinusitis with nasal polyposis; C01.748.749

• Registration Number: RBR-44h66b
• Lead Sponsor: Clinica Olfact

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2020-07-22
• Last Update Posted: 29 May 2023

Recruitment & Eligibility

• Status: Recruiting
• Sex: Not specified
• Target Recruitment: Not specified

Inclusion Criteria

Patients with a minimum nasal polyp score (SPL) of 5 out 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 before screening: nasal block, obstruction, congestion or rhinorrhea (anterior or posterior); facial pain / pressure; reduction or loss of smell

Exclusion Criteria

Patient under 18 years old, or over 55 years old; SNOT-22 with a sum of less than 7; Patients who used drugs or therapies that interfere with the results of this clinical trial, within 2 months before screening: treatment with immunosuppressants; anti-immunoglobulin medications and within two months before screening; Start of allergen immunotherapy in the 3 months prior to the first consultation or a plan to start therapy during the screening period or the randomized treatment period; Patients who have undergone any nasal surgery; Patients using anti-leukotrienes and antihistamines; Asthmatic patients will be excluded if: the forced expiratory volume (FEV1) is 60% of predicted or less; there has been an exacerbation requiring systemic steroidal treatment (oral and / or parenteral) or hospitalization for more than 24 hours for the treatment of asthma, in the 3 months prior to screening; use of a dose greater than 1000 mg of inhaled fluticasone or equivalent; Patients with short life expectancy (less than 6 months)

Study & Design

• Study Type: Intervention
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Check the reduction in Nasal Polyp Score by at least 3 points, comparing the initial result with the final one, after the end of the treatment

Secondary Outcome Measures

Name	Time	Method
Check the improvement of the results and scores in the other tests performed, comparing the initial result with the final one, after the end of the treatment