Chest
Clinical InvestigationsComparison of Three Jet Nebulizer Aerosol Delivery Systems Used to Administer Recombinant Human DNase I to Patients With Cystic Fibrosis
Section snippets
Study Design
Qualifying patients in this multicenter, open-label study were randomized to receive 2.5 mg of rhDNase twice daily, administered as an aerosol by means of one of the three test nebulizer systems (MA, HTU, or PLC). Randomization was stratified by study center using a permuted block design. Both verbal and video instructions on the proper use of the nebulizer were provided at the initial visit after randomization. At subsequent visits (8 and 15 days after entry), pulmonary function was evaluated
Patient Demographics
Twenty-six clinical sites in the United States entered a total of 397 patients: 134 patients used the MA nebulizer, 132 used the HTU nebulizer, and 131 used the PLC nebulizer. Demographic data and baseline pulmonary function were similar in all three groups (Table 2).
Efficacy
Pulmonary function improved to a similar extent with all three nebulizer systems. Average improvements were 13.2 to 14.1% for FEV1 (Table 3), 10.9 to 11.8% for FVC, and 16.5 to 17.1% for FEF25-75. No statistically significant
Discussion
Our results demonstrated no differences in the clinical effect of rhDNase with these three nebulizer systems. While these results are comforting, they cannot necessarily be extrapolated to other nebulizer systems until those systems have also been evaluated with rhDNase in vitro. Realistically, the wide variety of nebulizers commercially available precludes formal clinical testing of all of them with this product. However, one might reasonably suppose that if a nebulizer system has in vitro
Appendix
The Pulmozyme rhDNase Study Group includes the following investigators: C. C. Cipolla (Genentech, Inc, South San Francisco); A. Colin, MD (Boston); J. Colombo, MD, FCCP (Omaha, Neb); C. Denning, MD (New York); A. Dozor, MD (Valhalla, NY); H. Eigen, MD, FCCP (Indianapolis); J. Eisenberg, MD (Portland); R. Fink, MD (Washington); D. Geller, MD (St. Petersburg, Fla); R. Gerstle, MD (Springfield, Mass); L. Glasser, MD (Houston); C. Green, MD (Madison, Wis); L. Hernried, MD (Phoenix, Ariz); G.
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Pulmozyme rhDNase Study Group
The Pulmozvme rhDNase Study Group participants are listed at the end of this article.