St Luke's-Roosevelt Hospital (SL-R) in New York proposes to conduct a Phase Ha ascending dose, placebo-controlled clinical study to evaluate the safety of administering repeated doses of aerosolized hyaluronic acid (HA) twice daily over two weeks to subjects with chronic obstructive pulmonary disease (COPD). The double-blind study will include a total of 48 patients with COPD, at least 10 pack-years of cigarette use, and meeting additional patient selection criteria. The subjects will be divided into two cohorts of 24 (16:8 active:placebo), distributed among six independent clinical sites. The primary endpoints to assess safety include oxygen saturation, CO diffusing capacity, adverse events, physical examination, vital signs, electrocardiograms and laboratory evaluations. Two additional endpoints, spirometry and lung volumes, will be included to look for therapeutic benefits that might be possible even over the short course of the study, although observable therapeutic benefits are not expected. The study will also examine desmosine and isodesmosine content of urine, plasma and sputum. Trends in these specific biochemical markers of elastin protealysis may provide preliminary evidence of biological efficacy, which may anticipate observation of clinical efficacy in improving lung function in future studies of longer duration. COPD and pulmonary emphysema, a clinically advanced stage of COPD, devastate the health of millions of Americans. No approved, existing treatment can arrest the disease's progressive destruction of the lung. Aerosolized HA has the potential to become the first effective therapeutic product that alters the degenerative course of emphysema by preserving-and possibly even restoring-lung function. ? ? ?
