Chest
Volume 108, Issue 1, July 1995, Pages 153-156
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Clinical Investigations
Comparison of Three Jet Nebulizer Aerosol Delivery Systems Used to Administer Recombinant Human DNase I to Patients With Cystic Fibrosis

https://doi.org/10.1378/chest.108.1.153Get rights and content

Study objective: To compare the degree of improvement in pulmonary function achieved with recombinant human DNase I (rhDNase) administered by three different aerosol delivery systems: DeVilbiss Pulmo-Aide compressor with the Marquest Acorn II nebulizer, the Hudson T Up-draft nebulizer, and the Pari LC Jet Plus nebulizer with the Pari Inhalier Boy compressor. These produce similar aerosols in vitro in terms of size distribution and activity of delivered rhDNase.

Study design: Multicenter, 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 age with cystic fibrosis and baseline forced vital capacity (FVC) values between 40 and 70% of predicted values.

Results: All three nebulizers gave comparable improvements in pulmonary function. FEV1 increased by an average of 13.2 to 14.1%, FVC by 10.9 to 11.8%, and forced midexpiratory flow (FEF25-75) by 16.5 to 17.1%. No unusual or unexpected adverse 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 delivery and safety characteristics.

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.

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