Common cold viruses are leading triggers of asthma attacks, causing nearly two million hospitalizations per year and productivity losses approaching $40B.  They also increase susceptibility to bacterial infections driving antibiotic use. Post-market clinical studies have questioned the efficacy of most over the counter (OTC) cough and cold ingredients against placebo in treating various symptoms. To our knowledge, only aspirin significantly improved overall illness severity compared to placebo and that was by about 25-30%. In this double-blind randomized placebo-controlled trial involving 157 participants, we sought to determine whether a throat spray containing a mucosal immune complex (MIC) (comprised of lysozyme, lactoferrin, and aloe) can increase the hereto reported efficacy of aspirin at reducing common cold symptoms. Previously published reports showed that the MIC can protect respiratory epithelia and lower inflammatory cytokines. Participants self-administered treatments (throat sprays every hour and tablets every four hours) and completed surveys at home over two days. Treatments included MIC spray mixed with 6mg aspirin + placebo tablet (Treatment 1), MIC spray + placebo tablet (Treatment 2), MIC spray + 325 mg aspirin tablet (Treatment 3). Participants included adult volunteers ages 21-66 (average 44), 54% female, 46% male, 46% African American, 8% Asian, 39% Caucasian, and 7% Hispanic, having common cold symptoms lasting less than two days. The main outcome measures included Sore Throat Pain Intensity (STPIS) 0-100 at 36 hours (primary endpoint) and Modified Jackson Score (MJS), a combination of eight cold symptoms (secondary endpoint).   Both primary and secondary endpoints were met. Sore throat pain as measured by STPIS decreased 68-75% by 36 hours depending on treatment. Other symptoms such as nasal discharge, congestion, sneezing, cough, sore throat, and malaise as measured by MJS decreased 38-68% depending on treatment. In repeated measure within group analysis observing the same participants over multiple time points; STPIS mean change from baseline to 36 hours was as follows: Placebo (-7.84 (-14%) [95% CI -14.20 to -1.47]; p<0.0001), Treatment 1 (-42.41 (-75%)[95% CI -48.30 to -36.52]; p<0.0001), Treatment 2 (-38.60 (-68%)[95% CI -46.64 to -31.56]; p<0.0001), and Treatment 3 (-44.19 (-79%) [95% CI -52.11to -36.27]; p<0.0001). In repeated measure within group analysis all treatments significantly reduced cold symptom severity (MJS) from Days 1-2. Results were as follows: Treatment 1 (-2.26 (-38%) [95% CI -3.04 - -1.47] p<0.0001), Treatment 2 (-3.81 (-53%) [95% CI -4.82 - -2.80] p<0.0001), Treatment 3 (-4.49 (-69%) [95% CI -5.62- -3.57]; p<0.0001).   As a result of this study, we conclude that supporting upper respiratory epithelia and reducing COX-mediated inflammation may be used to effectively treat common cold symptoms.   Trial registration ClinicalTrials.gov Identifier: NCT06106880 Posted 30/10/2023

The authors are employees of Applied Biological Laboratories, Inc

NCT06106880

https://classic.clinicaltrials.gov/ct2/show/NCT06106880?term=NCT06106880

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The protocol for this trial was approved by the Advarra Institutional Review Board and written informed consent was obtained for all participants. This study followed the Consolidated Standards of Reporting Trials (CONSORT) reporting guidelines.

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