BACKGROUND Two studies of intranasal 0.5% carbomer 980 gel were conducted evaluating nasal tolerability in healthy volunteers and safety and efficacy in adults with common cold symptoms. METHODS Study 1 randomly assigned healthy adults to 0.5% carbomer 980 gel (n = 20) or placebo (n = 10) administered intranasally four times daily for 7 days. Nasal examinations were conducted at baseline and daily throughout the study. The primary endpoint was local nasal tolerability. Study 2 randomly assigned adults with an investigator-confirmed diagnosis of symptomatic common cold to 0.5% carbomer 980 gel (n = 87) or placebo (n = 81), administered intranasally four times daily for 7 days (except for day 1, where subjects who received their first dose mid-day administered only three doses). The primary efficacy endpoint was the average nasal symptom score over days 1‒4 (ANSS1-4). Secondary efficacy endpoints included ANSS over days 1‒7 and average total symptom score (ATSS). Adverse events (AEs) were recorded throughout the study. RESULTS In study 1, subjects assigned to 0.5% carbomer 980 gel had no mucosal grading higher than grade 1B (superficial nasal mucosal erosion) and low incidences of mucosal bleeding and crusting. In study 2, there were no statistically significant differences between treatments for any efficacy endpoints. Active treatment was well-tolerated; the most commonly reported AEs were headache, myalgia, and cough. CONCLUSION While 0.5% carbomer 980 gel nasal spray demonstrated good local nasal tolerability in healthy volunteers, the spray did not significantly impact the course of infection or resolution of cold symptoms in subjects with common cold.

中文翻译：

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0.5％Carbomer 980凝胶治疗普通感冒症状的安全性和有效性：2项随机试验的结果。

背景技术进行了两项鼻内0.5％卡波姆980凝胶的研究，以评估健康志愿者的鼻耐受性以及对患有普通感冒症状的成年人的安全性和有效性。方法研究1名健康成人，随机分配0.5％卡波姆980凝胶（n = 20）或安慰剂（n = 10），每天鼻内给药，每天4次，共7天。在整个研究过程中，在基线和每天进行鼻腔检查。主要终点是局部鼻耐受性。研究2个随机分配的成年人，经研究者确认诊断为有症状的普通感冒，症状为0.5％卡波姆980凝胶（n = 87）或安慰剂（n = 81），每天经鼻鼻腔给药7天（第1天除外）谁在中午收到第一剂疫苗，只接受三剂）。主要功效终点为第1至4天的平均鼻部症状评分（ANSS1-4）。次要疗效终点包括第1-7天的ANSS和平均总症状评分（ATSS）。在整个研究中记录不良事件（AE）。结果在研究1中，分配了0.5％卡波姆980凝胶的受试者的粘膜分级没有高于1B级（鼻腔粘膜浅表糜烂），且粘膜出血和结s的发生率较低。在研究2中，任何疗效终点的治疗之间均无统计学差异。积极治疗的耐受性良好；最常见的不良事件是头痛，肌痛和咳嗽。结论0.5％卡波姆980凝胶鼻喷雾剂在健康志愿者中表现出良好的局部鼻耐受性，