Phase I/II Study of Mild Asthmatics
Clinical Studies
An initial human Phase I/II study was conducted at the University of Connecticut Health Center, Farmington, CT, and the Hospital for Special Care, New Britain, CT. This trial was a combination safety and efficacy study that evaluated safety parameters in normal volunteers, and evaluated safety and efficacy parameters in patients diagnosed with mild bronchial asthma (60-80% predicted FEV1 or >12% reversibility to broncho-dilator).
Summary of Results
In summary the treatment of mild asthmatics, with 0.5mM concentration of pyruvate increased FEV1 values in 93% of the patients tested averaging 12%. (See Figures 1 and 2) In this same group of 15 patients, H2O2 levels were decreased on average by 51%, with 80% of the patients obtaining decreased H2O2 levels in their expired breath. The same patients treated with saline had no increase in FEV values and had a 61% increase in exhaled H2O2 levels. Patients treated with the 1.5mM concentrations had very little change in averaged FEV values. This group showed a 65% overall decrease in H2O2 levels with 86% of the patients obtaining a decrease in H2O2 levels. Patients treated with the 5mM concentrations had no significant change in FEV values. 67% of the patients showed a decrease in H2O2 by 50%. In summary inhalation of sodium pyruvate decreased lung inflammation as evidenced by decreasing H2O2 levels and increasing FEV values. Figure 3

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