Randomized, double-blind, placebo-controlled clinical trial to assess the safety and effectiveness of a novel dual-action oral topical formulation against upper respiratory infections

Abstract

BackgroundCurrent 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.MethodsARMS-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.ResultsOf 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.ConclusionsThis 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.Trial registrationClinicalTrials.gov NCT02644135 (retrospectively registered).Electronic supplementary materialThe online version of this article (doi:10.1186/s12879-016-2177-8) contains supplementary material, which is available to authorized users.

Topical lignocaine anaesthesia for oropharyngeal sampling for COVID-19

“…Preservatives like cetylpyridinium chloride are used in lignocaine preparations, which have antimicrobial properties [12]. These facts prompted us towards a theoretical concern of tampered sample quality with lignocaine usage.…”

Is the oral cavity relevant in SARS-CoV-2 pandemic?

“…In humans, in a pilot double-blinded, placebo-controlled, randomized clinical trial, assessing a CPC-based formulation for inhalation, in the prevention of upper respiratory tract infections (usually associated with influenza virus, RSV, human metapneumovirus (hMPV), rhinovirus, and adenovirus), it was observed that patients in the test group suffered viral infections with less severity and duration, when compared with those included in the placebo group [39].…”

Use of mouthwashes against COVID-19 in dentistry

“…33 The antiviral effect of CPC has been demonstrated in influenza patients, significantly reducing the duration and severity of cough and sore throat. 31,34 Hypotheses about a possible action over SARS-CoV-2 are based on its lysosomotropic mechanism of action and its ability to destroy viral capsids. 35 These findings indicate that CPC could be effective against other enveloped viruses such as coronaviruses.…”