EmphyCorp Completes Analysis of Hydrogen Peroxide Respiratory Study
October 15, 2003
Purpose
The purpose of this study was two-fold: (1) to test the safety and therapeutic efficacy of inhaled sodium pyruvate, an endogenous compound with anti-inflammatory properties (anti-oxidant), in individuals with mild bronchial asthma and (2) to determine if inhaled sodium pyruvate could reduce the level of hydrogen peroxide in the expired breath of these subjects. The study entitled “Inhaled Sodium Pyruvate for the Treatment of Bronchial Asthma” was conducted at the University of Connecticut Health Center, Farmington, CT, and the Hospital for Special Care, New Britain, CT.
Protocol
Three concentrations of sodium pyruvate were studied; 0.5 mM, 1.5 mM, and 5.0 mM. Sixty subjects completed the study – 15 non-asthmatic control individuals and 45 individuals with mild bronchial asthma. Non-asthmatic control individuals were divided into three groups of 5 subjects; each group received one of the three concentrations of sodium pyruvate. Individuals with mild bronchial asthma were divided into three groups of 15 subjects; each group received one of the three concentrations of sodium pyruvate. Each subject first inhaled a single dose of physiological saline and on a return visit inhaled a single dose of 5.0 ml of one of the concentrations of sodium pyruvate. Expired breath was collected 1 hour prior to and 1 hour post inhalation of either physiological saline or sodium pyruvate. Lung function assessments and vital signs were monitored at baseline and at 15 minutes, 30 minutes, 1 hour, 2 hours and 4 hours post inhalation of sodium pyruvate or physiological saline.
Results
There were no Serious Adverse Events noted in any of the subjects studied. There were Non-Serious Adverse Events recorded from 17 subjects; only 6 of these were regarded as either Doubtful or Possibly Related to Study Drug. No therapeutic action was warranted with any of these events and each resolved without sequelae. No physiological alterations occurred which caused study termination of any of the participants after the inhalation of sodium pyruvate. In addition, a statistically significant improvement (greater than 10%) in percent change in FEV1 was observed in subjects with mild bronchial asthma at 15 minutes, 30 minutes, 1 hour and 2 hours post inhalation of 0.5 mM sodium pyruvate as compared to the inhalation of physiological saline. No significant change in the FEV1 was observed in subjects with mild bronchial asthma after the inhalation of sodium pyruvate at either the 1.5 mM or 5.0 mM concentrations. A significant elevation in expired breath hydrogen peroxide levels was observed in subjects with mild bronchial asthma as compared to non-asthmatic control individuals. In addition, a statistically significant (p<0.02) decrease in H2O2 levels in expired breath was observed in subjects with mild bronchial asthma after the inhalation of 1.5 mM sodium pyruvate as compared to the inhalation of physiological saline. We were unable to detect any significant change in H2O2 levels in expired breath after the inhalation of 0.5 mM or 5.0 mM concentrations of sodium pyruvate in subjects with mild bronchial asthma as compared to the inhalation of physiological saline.
Conclusions
The inhalation of a single dose of sodium pyruvate was tolerated well in all subjects and appears to be safe. Therapeutic efficacy was suggested at the 0.5 mM dose of sodium pyruvate by a clinically relevant (greater than 10%) percent change in FEV1.
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