Chronic rhinosinusitis with nasal polyposis
Conditions
Interventions
Patients with chronic rhinosinusitis with polyposis will be randomly divided with stratification for the presence of asthma in two groups (two blocks of 30 patients, with 9 asthmatics in each). It wil
Drug
Sponsors
Clinica Olfact
Clinica Olfact
Eligibility
Age
18 Years to 55 Years
Inclusion criteria
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
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)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
Brazil
Contacts
Public ContactMarco Fornazieri
Clinica Olfact
Outcome results
None listed