EFFECTS OF AEROSOLIZED SURFACTANT IN PATIENTS WITH STABLE CHRONIC-BRONCHITIS - A PROSPECTIVE RANDOMIZED CONTROLLED TRIAL

Context.-Chronic bronchitis, estimated to affect more than 13 million adults in the United States, is characterized in part by retention of airway secretions, but no approved or effective therapy for airway muc us retention in patients with chronic bronchitis has been established. Surfactant reduces sputum adhesiveness, which contributes to difficul ty in clearing secretions, but surfactant has not been tested in patie nts with chronic bronchitis. Objective.-To examine the effects of exog enous surfactant on sputum clearance and pulmonary function in patient s with stable chronic bronchitis. Design.-A prospective, multicenter, randomized, double-blind, parallel-group, placebo-controlled compariso n of the effects of 2 weeks of treatment with 3 doses of aerosolized s urfactant (palmitoylphosphadidylcholine [DPPC]) or saline (placebo). S etting.-Four US teaching hospitals. Participants.-A total of 87 adult patients with the diagnosis of stable chronic bronchitis. Main Outcome Measures.-Pulmonary function, respiratory symptoms, and sputum proper ties before treatment (day 0), after 2 weeks of treatment (day 14), an d 7 days after stopping treatment (day 21). Results.-A total of 66 pat ients were randomized to surfactant treatment and 21 to saline treatme nt. Patient demographic characteristics between groups were similar at baseline, In patients who received a DPPC dose of 607.5 mg/d for 2 we eks, prebronchodilator forced expiratory volume in 1 second (FEV1) inc reased from 1.22 L (SEM, 0.08 L) at day 0 to 1.33 L (SEM, 0.09 L) at d ay 21 (P=.05), an improvement of 11.4%; postbronchodilator FEV1 improv ed 10.4% by days 14 and 21 (P=.02); and the ratio of residual volume t o total lung capacity, a measure of thoracic gas trapping, decreased 6 .2% by day 21 (P=.009). In the surfactant groups, there was a dose-dep endent increase in the ability of sputum to be transported by cilia in vitro. Conclusion.-Aerosolized surfactant improved pulmonary function and resulted in a dose-related improvement in sputum transport by cil ia in patients with stable chronic bronchitis.