Efficacy of adding high volume diluted Budesonide nasal lavage for maximum clinical treatment in patients with Chronic Rhinosinusitis with polyposis: double-blind, randomized, controlled study

Clinica Olfact0 个研究点开始时间: 2020年7月22日最近更新: 2023年5月29日

试验速览

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•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

•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)

发起方

Clinica Olfact