SALT LAKE CITY--(BUSINESS WIRE)--A newly published Random Clinical Trial (RCT) provides additional support for statements Xlear made about the use of nasal hygiene as an added layer of protection in combatting the SARS-CoV-2 virus. The Federal Trade Commission (FTC) has sued Xlear concerning prior statements. Most importantly, the new RCT pilot study found no anosmia (loss of sense of smell) among the outpatients who used Xlear. Xlear has provided this new research to the Dept. of Justice in the ongoing FTC lawsuit.
“This week the FDA is expected to approve new vaccines without any clinical data on safety and efficacy,” Nate Jones CEO of Xlear said quoting stories from the Wall Street Journali and MarketWatch.ii “These articles say the FDA will rely on real world evidence from the use of prior mRNA shots as proof the vaccines are safe. They’re relying on information that isn’t even from these specific vaccines to approve them. At the same time, Xlear has been used by millions of Americans for 20-plus years without a single adverse effect report. And, these and other trials show saline and saline-based nasal sprays are effective at washing pathogens out of the nose and thereby reducing viral load in the nose. The FDA is about to approve these vaccines for millions of Americans with no data. Yet, when we say these things, based on actual studies like these, the FTC sues us. It’s nonsense,” he added.
The new RCT, “Intranasal Xylitol for the Treatment of COVID-19 in the Outpatient Setting: A Pilot Study”, involved 50 out-patient adults, all already infected with COVID-19. The results found with both Xlear and saline align with (confirm) earlier RCT’s showing nasal hygiene with simple saline helps reduce the duration and severity of COVID-19 illnesses. None of the patients in the new RCT died, none were hospitalized or required emergency visits, and no adverse reactions were reported. The Study can be found at: https://www.cureus.com/articles/100176-intranasal-xylitol-for-the-treatment-of-covid-19-in-the-outpatient-setting-a-pilot-study
“A series of RCT’s have shown that saline nasal irrigation reduces the duration and severity of COVID-19 cases in those already infected with COVID-19.iii Although the Government agrees Xlear is a saline-based nasal spray. The Government has refused to accept the results of these saline RCT’s as substantiation, proof, that Xlear can serve as an additional layer of defense against COVID-19. Most importantly, this RCT found that Xlear was as effective as saline in helping reduce the duration and severity of the disease course. This type of study is known as a ‘noninferiority trial,’” Nathan Jones, CEO of Xlear explained. Per ethics rules, there was no nonintervention cohort. There were no changes in outcomes based upon the vaccination status.
The new RCT also found that none of the individuals given Xlear developed ansomia (loss of the sense of smell), whereas individuals in the saline cohort did develop this symptom. The researchers note anosmia impacts a significant portion of post-COVID patients for months after the initial illness and, “Hence, the use of intranasal xylitol in the context of early COVID-19 infection may well serve as a preventative treatment to avoid persistent COVID-19-induced anosmia.” A recent study in the British Medical Journal found: “Change in the sense of smell and taste is highly prevalent in patients with covid-19, with 40-50% of people on average reporting these symptoms globally, and up to 98% showing olfactory dysfunction when tested objectively.”iv
The trial, which was performed in the Dominican Republic, by a team of international respiratory disease experts/physicians and was approved and monitored by National Council of Bioethics in Health (CONABIOS).
This product is not intended to diagnose, treat, cure, or prevent any disease.
_____________________
iii Kimura, K., et al., Interim analysis of an open-label randomized controlled trial evaluating nasal irrigations in nonhospitalized patients with coronavirus disease 2019. Int Forum Allergy Rhinol. 2020; 10: 1325– 1328, available at https://pubmed.ncbi.nlm.nih.gov/32914928/; Amy Baxter, et al., Rapid initiation of nasal saline irrigation to reduce morbidity and mortality in COVID+ outpatients: a randomized clinical trial compared to a national dataset, medRxiv 2021.08.16.21262044, doi:https://doi.org/10.1101/2021.08.16.21262044 available at https://www.medrxiv.org/content/10.1101/2021.08.16.21262044v2. A third pilot trial using Xlear also concludes the same: Go et al., Potential Role of Xylitol Plus Grapefruit Seed Extract Nasal Spray Solution in COVID-19: Case Series, Cureus, 2020 Nov; 12(11): e11315, available at https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7645297/ .
iv Tan B K J, Han R, Zhao J J, Tan N K W, Quah E S H, Tan C J et al. Prognosis and persistence of smell and taste dysfunction in patients with covid-19: meta-analysis with parametric cure modelling of recovery curves BMJ 2022; 378 :e069503 doi:10.1136/bmj-2021-069503, available at https://www.bmj.com/content/378/bmj-2021-069503.
