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Exogenously administered sodium pyruvate has a variety of biological effects including antioxidant/anti-inflammatory effects. Chronic obstructive pulmonary disease (COPD) is an inflammatory disease of the airways mediated in part by reactive oxygen species (ROS) and reactive nitrogen species (RNS). The current therapies for COPD have limited efficacy. This study was designed to test the safety and therapeutic efficacy of inhaled pyruvate in COPD patients. Subjects were randomized to receive either sodium pyruvate or placebo three times per day over a 6-week period. Long-term efficacy was evaluated by spirometry and expired breath nitric oxide (NO) levels taken at baseline, 3 days, 1 week, 2 weeks, 4 weeks, and 6 weeks. In addition, acute assessments (1 h pre- and 1 h postinhalation of compound) were made at day 0 and at 4 weeks. Subjects receiving inhaled pyruvate showed significant (p < 0.02) improvement of approximately 11% in forced expiratory volume in 1 sec (FEV(1)) at 6 weeks, whereas subjects receiving placebo did not. The inhalation of pyruvate or placebo had no significant effect on expired breath NO levels at any of the long-term outcome time points; measurements were made 12 h after the last inhalation of the compound. In contrast, acute assessments (1 h pre-and 1 h postinhalation of compound) of expired breath NO made at 4 weeks demonstrated that inhalation of pyruvate resulted in a significant (p