Comparison of three jet nebulizer aerosol delivery systems used to administer recombinant human DNase I to patients with cystic fibrosis

Stanley Fiel, H. J. Fuchs, C. Johnson, I. Gonda, A. R. Clark, C. C. Cipolla, A. Colin, J. Colombo, C. Denning, A. Dozor, H. Eigen, J. Eisenberg, R. Fink, D. Geller, L. Glasser, L. Gerstle, C. Green, L. Hernried, G. Johnson

Research output: Contribution to journalArticle

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Abstract

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 Updraft 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.

Original languageEnglish (US)
Pages (from-to)153-156
Number of pages4
JournalChest
Volume108
Issue number1
DOIs
StatePublished - Jan 1 1995
Externally publishedYes

Fingerprint

Nebulizers and Vaporizers
Deoxyribonuclease I
Aerosols
Cystic Fibrosis
Lung
Vital Capacity
Ambulatory Care Facilities
Multicenter Studies
dornase alfa
Safety
Pharmaceutical Preparations
In Vitro Techniques

All Science Journal Classification (ASJC) codes

  • Pulmonary and Respiratory Medicine
  • Critical Care and Intensive Care Medicine
  • Cardiology and Cardiovascular Medicine

Cite this

Fiel, Stanley ; Fuchs, H. J. ; Johnson, C. ; Gonda, I. ; Clark, A. R. ; Cipolla, C. C. ; Colin, A. ; Colombo, J. ; Denning, C. ; Dozor, A. ; Eigen, H. ; Eisenberg, J. ; Fink, R. ; Geller, D. ; Glasser, L. ; Gerstle, L. ; Green, C. ; Hernried, L. ; Johnson, G. / Comparison of three jet nebulizer aerosol delivery systems used to administer recombinant human DNase I to patients with cystic fibrosis. In: Chest. 1995 ; Vol. 108, No. 1. pp. 153-156.
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title = "Comparison of three jet nebulizer aerosol delivery systems used to administer recombinant human DNase I to patients with cystic fibrosis",
abstract = "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 Updraft 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.",
author = "Stanley Fiel and Fuchs, {H. J.} and C. Johnson and I. Gonda and Clark, {A. R.} and Cipolla, {C. C.} and A. Colin and J. Colombo and C. Denning and A. Dozor and H. Eigen and J. Eisenberg and R. Fink and D. Geller and L. Glasser and L. Gerstle and C. Green and L. Hernried and G. Johnson",
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Fiel, S, Fuchs, HJ, Johnson, C, Gonda, I, Clark, AR, Cipolla, CC, Colin, A, Colombo, J, Denning, C, Dozor, A, Eigen, H, Eisenberg, J, Fink, R, Geller, D, Glasser, L, Gerstle, L, Green, C, Hernried, L & Johnson, G 1995, 'Comparison of three jet nebulizer aerosol delivery systems used to administer recombinant human DNase I to patients with cystic fibrosis', Chest, vol. 108, no. 1, pp. 153-156. https://doi.org/10.1378/chest.108.1.153

Comparison of three jet nebulizer aerosol delivery systems used to administer recombinant human DNase I to patients with cystic fibrosis. / Fiel, Stanley; Fuchs, H. J.; Johnson, C.; Gonda, I.; Clark, A. R.; Cipolla, C. C.; Colin, A.; Colombo, J.; Denning, C.; Dozor, A.; Eigen, H.; Eisenberg, J.; Fink, R.; Geller, D.; Glasser, L.; Gerstle, L.; Green, C.; Hernried, L.; Johnson, G.

In: Chest, Vol. 108, No. 1, 01.01.1995, p. 153-156.

Research output: Contribution to journalArticle

TY - JOUR

T1 - Comparison of three jet nebulizer aerosol delivery systems used to administer recombinant human DNase I to patients with cystic fibrosis

AU - Fiel, Stanley

AU - Fuchs, H. J.

AU - Johnson, C.

AU - Gonda, I.

AU - Clark, A. R.

AU - Cipolla, C. C.

AU - Colin, A.

AU - Colombo, J.

AU - Denning, C.

AU - Dozor, A.

AU - Eigen, H.

AU - Eisenberg, J.

AU - Fink, R.

AU - Geller, D.

AU - Glasser, L.

AU - Gerstle, L.

AU - Green, C.

AU - Hernried, L.

AU - Johnson, G.

PY - 1995/1/1

Y1 - 1995/1/1

N2 - 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 Updraft 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.

AB - 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 Updraft 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.

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