COMPARISON OF 3 JET NEBULIZER AEROSOL DELIVERY SYSTEMS USED TO ADMINISTER RECOMBINANT HUMAN DNASE-I TO PATIENTS WITH CYSTIC-FIBROSIS

Study objective: To compare the degree of improvement in pulmonary fun ction achieved with recombinant human DNase I (rhDNase) administered b y three different aerosol delivery systems: De Vilbiss Pulmo-Aide comp ressor with the Marquest Acorn II nebulizer, the Hudson T Up-draft neb ulizer, and the Pari LC Jet Plus nebulizer with the Pari Inhalier Boy compressor. These produce similar aerosols in vitro in terms of size d istribution and activity of delivered rhDNase. Study design: Multicent er, randomized, open-label, parallel-group comparison of changes from baseline in pulmonary function variables in each test group. Patients were treated with rhDNase (2.5 mg bid) for 15 days, administered with three different aerosol delivery systems. Setting: Outpatient clinics at 26 sites in the United States. Patients: 397 patients >5 years of a ge with cystic fibrosis and baseline forced vital capacity (FVC) value s between 40 and 70% of predicted values. Results: All three nebulizer s gave comparable improvements in pulmonary function. FEV(1) increased by an average of 13.2 to 14.1%, FVC by 10.9 to 11.8%, and forced mide xpiratory now (FEF25-75) by 16.5 to 17.1%. No unusual or unexpected ad verse events were reported other than those that would be expected in patients with cystic fibrosis. Conclusions: Recombinant human DNase I produced a similar magnitude of improvement in the pulmonary function of patients with cystic fibrosis when the drug was administered using three different types of nebulizer systems with similar in vitro deliv ery and safety characteristics.