NASAL SPRAY STUDIES

EmphyCorp Clinical Trials

NASAL SPRAY STUDIES

Until now the primary treatment for allergic rhinitis, asthmatic bronchitis and chronic obstructive pulmonary diseases is the use of corticosteroids (67%). It is well documented that prolonged use of corticosteroids for the treatment of pulmonary diseases has serious side effects, including death. Other marketed drugs for the treatment of pulmonary diseases can produce central nervous system, cardiovascular, respiratory and gastrointestinal problems.

Sodium Pyruvate Nasal Spray Studies: Safety and Efficacy Data submitted to the FDA

Clinical Trial 1:  Twenty-four subjects.  All subjects completed the study, and none opted to return to their normal nasal spray therapy during this period. The data obtained from the rhinoscopic examinations indicated that the Sodium Pyruvate + Saline Nasal Spray did not induce dermal irritation and was effective in significantly (p=0.006) reducing the erythema in subjects who normally use either saline or non-saline nasal sprays like steroids,  when pre-test ratings were compared to post-test ratings.

Clinical Trial 2: Thirty-nine subjects who were regular nasal spray users due to chronic sinusitis or allergic rhinitis were recruited for this one-week open label, in home-use trial. Thirty-eight subjects completed the study. The data obtained from the rhinoscopic examinations indicated that Sodium Pyruvate + Saline Nasal Spray did not induce dermal irritation and was effective in reducing the erythema in subjects who normally use either saline or non-saline nasal sprays when pre-test ratings were compared to post-test ratings.

Clinical Trial 3: Fourteen-Day In-Use Evaluation of Nasal Sprays Containing Sodium Pyruvate and Reduced Steroids.  “Reduced-Strength Flonase®” and “Reduced-Strength Nasacort®” Test Product nasal sprays with sodium pyruvate  were found to be as effective as the “full-strength” (i.e. commercial) Flonase® and more effective than the commercial Nasacort® when the reduced commercial “active ingredients” were delivered to the subjects.

Clinical Trial 4: Fifty-three subjects. Treatment Effect of Sodium Pyruvate nasal saline spray on allergic Rhinitis. Randomized Placebo controlled study.  Results Sodium pyruvate nasal spray was effective in attenuating rhino conjunctivitis symptoms and reducing rescue medications use in allergic rhinitis patients. 

Clinical Trial 5: One hundred and thirty subjects. Blinded saline placebo controlled nasal spray study against a sodium pyruvate formulation in allergic Rhinitis patients.  Results: The sodium pyruvate formulation was clinically and statistically superior to saline in reducing nasal inflammation and congestion.

Clinical Trial 6:  Sixty subjects. Random and positive controlled clinical trial to evaluate the efficacy and safety of the sodium pyruvate nasal spray in the treatment of Chronic Rhinitis (allergic and non-allergic) Results: The use of a Sodium pyruvate nasal spray was safe and effective and clinically superior to saline in reducing nasal symptoms in these patients.

Clinical Study 7: Seventy-seven subjects. Research on the efficacy of sodium pyruvate nasal spray to treat mild to moderate Allergic Rhinitis. Results: Sodium pyruvate nasal spray, as a non-drug treatment, can effectively improve the symptoms of mild to moderate AR.

Clinical Trial 8:  Human Mucociliary clearance time (MCT) studies.  Several studies have shown the effect of nasal saline on MCT. Our investigators have found isotonic saline sped clearance time by 2%, while the Sodium pyruvate nasal formula sped clearance by 17% 10-20 minutes after treatment in 32 adults.

Summary

In all patients tested, (92%) of these patients stated that the Pyruvate + Saline Nasal Sprays opened their nasal passages and cleared their congestion for over 12 hours. In each study the Sodium Pyruvate + Saline Nasal Sprays were objectively and subjectively judged to be “Comparable To” or “Better Than” both Saline or Steroid-based commercial nasal sprays. To date millions of Patients have inhaled Sodium Pyruvate with no adverse events reported. 

Evaluation of the Sodium Pyruvate Formulation to Deliver Other Drugs

Nicotine Inhalation with Pyruvate in the Sinuses or Lungs. We placed nicotine into a modified pyruvate nasal solution and discovered that inhaled nicotine (nasal or lungs) was well tolerated over nicotine by itself, which was irritating. The combination was synergistic. Forty Smokers who used this formula rated the pyruvate nicotine formula much higher than nicotine by itself.  The 20mM pyruvate solution in combination with nicotine balanced the negative effect of nicotine and enhanced the effect of nicotine. 

Insulin Inhalation with Pyruvate in the Sinuses or Lungs. The addition of pyruvate enhanced insulin uptake for patients that have diabetes with pulmonary lung or sinus diseases.  The 20mM pyruvate solution in combination with insulin balanced the negative effect of insulin and enhanced the effect of insulin.  

Sodium Pyruvate: Cellular, Biochemical and Pharmacology Background

Biochemical and Pharmacology Background

Sodium Pyruvate is biochemically classified as an α-ketoacid and is part of the body’s natural endogenous anti-oxidant defense system. It is secreted by cells, readily enters cells, and can directly react to detoxify detrimental compounds such as H2O2 and peroxynitrites. Sodium Pyruvate has been shown to significantly reduce inflammatory agents in all parts of the human body including the lungs and the nasal cavities. The inflammatory agents being reduced include hydrogen peroxide, nitric oxide, IL-8, TNF, and other inflammatory cytokines, that are produced by oxygen radicals.

Animal Safety Studies: Rat Study for 180 Days - Nose Only Inhalation Study

Animal Safety Studies

The rats were given more than 10X the 5mM dosages used in human inhalation studies. If you include the difference in body weights of humans vs. rats the concentrations tested were 100X the 5mM concentrations. After 180 days, the remaining rats from each group were sacrificed. As before, at necropsy, gross morphological observations on lung, liver, kidney, heart, and body weights were recorded. Histopathological evaluations were performed on lung, trachea, larynx, nose, liver, heart, and kidneys.

Safety of Pyruvate for Nasal Products and List of Products with Pyruvate

Sodium Pyruvate

Sodium Pyruvate is a natural and ubiquitous biochemical antioxidant component of the human mammalian system that is critical to cells and the survival of mitochondria, the power house of all living cells. It is involved in a myriad of biochemical reactions, and is a critical and necessary component involved in the biochemical cascade leading to the Krebs Cycle reactions.

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