Mukherjee Pranab K, Esper Frank, Buchheit Ken, Arters Karen, Adkins Ina, Ghannoum Mahmoud A, Salata Robert A
Center for Medical Mycology, University Hospitals Cleveland Medical Center and Case Western Reserve University, Cleveland, OH, USA.
Division of Pediatric Infectious Diseases, University Hospitals Cleveland Medical Center and Case Western Reserve University, Cleveland, USA.
BMC Infect Dis. 2017 Jan 14;17(1):74. doi: 10.1186/s12879-016-2177-8.
Current prevention options for upper respiratory infections (URIs) are not optimal. We conducted a randomized, double-blinded, placebo-controlled pilot clinical trial to evaluate the safety and efficacy of ARMS-I™ (currently marketed as Halo™) in the prevention of URIs.
ARMS-I is patented novel formulation for the prevention and treatment of influenza, comprising a broad-spectrum antimicrobial agent (cetylpyridinium chloride, CPC) and components (glycerin and xanthan gum) that form a barrier on the host mucosa, thus preventing viral contact and invasion. Healthy adults (18-45 years of age) were randomized into ARMS-I or placebo group (50 subjects each). The drug was sprayed intra-orally (3× daily) for 75 days. The primary objectives were to establish whether ARMS-I decreased the frequency, severity or duration of URIs. Secondary objectives were to evaluate safety, tolerability, rate of virus detection, acceptability and adherence; effect on URI-associated absenteeism and medical visits; and effect of prior influenza vaccination on study outcomes.
Of the 94 individuals who completed the study (placebo: n = 44, ARMS-I: n = 50), six presented with confirmed URI (placebo: 4, ARMS-I: 2), representing a 55% relative reduction, albeit this was statistically not significant). Influenza, coronavirus or rhinovirus were detected in three participants; all in the placebo group. Moreover, frequency of post-treatment exit visits was reduced by 55% in ARMS-I compared to the placebo group (N = 4 and 2, respectively). Fever was reported only in the placebo group. ARMS-I significantly reduced the frequency and severity of cough and sore throat, and duration of cough (P ≤ .019 for all comparisons). ARMS-I was safe, well tolerated, had high acceptability and high adherence to medication use. Medical visits occurred only in the placebo group while absenteeism did not differ between the two arms. Prior influenza vaccination had no effect on study outcome.
This randomized proof-of-concept clinical trial demonstrated that ARMS-I tended to provide protection against URIs in the enrolled study participants, while reducing severity and duration of cough and sore throat. A clinical trial with a larger number of study participants is warranted.
ClinicalTrials.gov NCT02644135 (retrospectively registered).
目前上呼吸道感染（URIs）的预防方法并不理想。我们进行了一项随机、双盲、安慰剂对照的试点临床试验，以评估ARMS-I™（目前以Halo™销售）预防URIs的安全性和有效性。
ARMS-I是一种用于预防和治疗流感的专利新型制剂，包含一种广谱抗菌剂（十六烷基氯化吡啶，CPC）和在宿主粘膜上形成屏障的成分（甘油和黄原胶），从而防止病毒接触和入侵。健康成年人（18至45岁）被随机分为ARMS-I组或安慰剂组（每组50名受试者）。药物通过口腔内喷雾（每日3次）给药75天。主要目标是确定ARMS-I是否降低了URIs的频率、严重程度或持续时间。次要目标是评估安全性、耐受性、病毒检测率、可接受性和依从性；对与URIs相关的缺勤和就诊的影响；以及先前流感疫苗接种对研究结果的影响。
在完成研究的94名个体中（安慰剂组：n = 44，ARMS-I组：n = 50），有6人确诊为URIs（安慰剂组：4人，ARMS-I组：2人），相对降低了55%，尽管这在统计学上不显著）。在三名参与者中检测到流感、冠状病毒或鼻病毒；均在安慰剂组。此外，与安慰剂组相比，ARMS-I组治疗后复诊次数减少了55%（分别为N = 4和2）。仅在安慰剂组报告有发热。ARMS-I显著降低了咳嗽和喉咙痛的频率和严重程度以及咳嗽持续时间（所有比较中P≤0.019）。ARMS-I安全、耐受性良好、具有高可接受性和高用药依从性。就诊仅发生在安慰剂组，而两组之间的缺勤情况没有差异。先前的流感疫苗接种对研究结果没有影响。
这项随机概念验证临床试验表明，ARMS-I倾向于为纳入研究的参与者提供针对URIs的保护，同时降低咳嗽和喉咙痛的严重程度和持续时间。有必要进行一项有更多研究参与者的临床试验。
ClinicalTrials.gov NCT02644135（回顾性注册）
