Antila Martti Anton, Castro Fabio Morato, Sano Flavio, Machado Adelmir, Fernandes Fatima, Rosário Filho Nelson Augusto, Stelmach Rafael
Clínica de Alergia Martti Antila (CMPC), Sorocaba, SP, Brazil.
Universidade de São Paulo (FMUSP), Faculdade de Medicina, São Paulo, SP, Brazil.
Braz J Otorhinolaryngol. 2016 Sep-Oct;82(5):580-8. doi: 10.1016/j.bjorl.2015.11.009. Epub 2016 Feb 15.
Allergic rhinitis is considered the most prevalent respiratory disease in Brazil and worldwide, with great impact on quality of life, affecting social life, sleep, and also performance at school and at work.
To compare the efficacy and safety of two formulations containing mometasone furoate in the treatment of mild, moderate, or severe persistent allergic rhinitis after four weeks of treatment.
Phase III, randomized, non-inferiority, national, open study comparing mometasone furoate in two presentations (control drug and investigational drug). The primary endpoint was the percentage of patients with reduction of at least 0.55 in nasal index score (NIS) after four weeks of treatment. Secondary outcomes included total nasal index score score after four and 12 weeks of treatment; individual scores for symptoms of nasal obstruction, rhinorrhea, sneezing, and nasal pruritus; as well as score for pruritus, lacrimation, and ocular redness after four and 12 weeks of treatment. The study was registered at clinicaltrials.gov with the reference number NCT01372865.
The efficacy primary analysis demonstrated non-inferiority of the investigational drug in relation to the control drug, since the upper limit of the confidence interval (CI) of 95% for the difference between the success rates after four weeks of treatment (12.6%) was below the non-inferiority margin provided during the determination of the sample size (13.7%). Adverse events were infrequent and with mild intensity in most cases.
The efficacy and safety of investigational drug in the treatment of persistent allergic rhinitis were similar to the reference product, demonstrating its non-inferiority.
变应性鼻炎被认为是巴西乃至全球最常见的呼吸道疾病，对生活质量有很大影响，会影响社交生活、睡眠以及学习和工作表现。
比较两种糠酸莫米松制剂在治疗轻度、中度或重度持续性变应性鼻炎四周后的疗效和安全性。
一项全国性、随机、非劣效性、开放的III期研究，比较两种剂型的糠酸莫米松（对照药物和试验药物）。主要终点是治疗四周后鼻指数评分（NIS）降低至少0.55的患者百分比。次要结局包括治疗四周和十二周后的总鼻指数评分；鼻塞、流涕、打喷嚏和鼻痒症状的个体评分；以及治疗四周和十二周后的瘙痒、流泪和眼充血评分。该研究已在clinicaltrials.gov注册，注册号为NCT01372865。
疗效初步分析表明试验药物相对于对照药物具有非劣效性，因为治疗四周后成功率差异的95%置信区间（CI）上限（12.6%）低于样本量确定时提供的非劣效界值（13.7%）。不良事件发生率低，多数情况下强度较轻。
试验药物在治疗持续性变应性鼻炎方面的疗效和安全性与参比产品相似，证明其非劣效性。
