Aerosolized recombinant human DNase in hospitalized cystic fibrosis patients with acute pulmonary exacerbations

R. W. Wilmott, R. S. Amin, Andrew Colin, A. DeVault, A. J. Dozor, H. Eigen, C. Johnson, L. A. Lester, K. McCoy, L. P. McKean, R. Moss, M. L. Nash, C. Pagel Jue, W. Regelmann, D. C. Stokes, H. J. Fuchs

Research output: Contribution to journalArticle

60 Citations (Scopus)

Abstract

The goal of this study was to evaluate the safety and efficacy of recombinant human DNase (rhDNase) in hospitalized patients with cystic fibrosis (CF) experiencing acute pulmonary exacerbations. Eighty patients with documented CF were enrolled at 11 CF centers when admitted for antibiotic therapy. Patients were at least 5 yr old with a forced vital capacity (FVC) ≥ 35% of predicted and an oxygen saturation ≥ 90% on a fraction of inspired oxygen (FI(O2)) < 0.5. Patients were randomized to receive rhDNase 2.5 mg in 2.5 ml excipient twice a day (n = 43) or 2.5 ml excipient alone twice daily (n = 37) along with conventional treatment for exacerbations. Administration of rhDNase was not associated with acute adverse events or deaths, and no patients experienced allergic or anaphylactic reactions. Although forced expiratory volume in one second (FEV1) and FVC improved in both treatment groups during the double-blind period, there were no statistically significant differences in the mean change from baseline in FEV1 or FVC between the two groups. rhDNase therapy is safe and well tolerated in CF patients with acute exacerbations requiring hospitalization, but the study did not demonstrate a statistically significant therapeutic effect of rhDNase when added to a regimen of antibiotics and chest physical therapy.

Original languageEnglish
Pages (from-to)1914-1917
Number of pages4
JournalAmerican Journal of Respiratory and Critical Care Medicine
Volume153
Issue number6 I
StatePublished - Jul 1 1996
Externally publishedYes

Fingerprint

Cystic Fibrosis
Lung
Vital Capacity
Excipients
Oxygen
Anti-Bacterial Agents
Therapeutics
Forced Expiratory Volume
Anaphylaxis
Therapeutic Uses
dornase alfa
Hypersensitivity
Hospitalization
Thorax
Safety

ASJC Scopus subject areas

  • Pulmonary and Respiratory Medicine

Cite this

Wilmott, R. W., Amin, R. S., Colin, A., DeVault, A., Dozor, A. J., Eigen, H., ... Fuchs, H. J. (1996). Aerosolized recombinant human DNase in hospitalized cystic fibrosis patients with acute pulmonary exacerbations. American Journal of Respiratory and Critical Care Medicine, 153(6 I), 1914-1917.

Aerosolized recombinant human DNase in hospitalized cystic fibrosis patients with acute pulmonary exacerbations. / Wilmott, R. W.; Amin, R. S.; Colin, Andrew; DeVault, A.; Dozor, A. J.; Eigen, H.; Johnson, C.; Lester, L. A.; McCoy, K.; McKean, L. P.; Moss, R.; Nash, M. L.; Pagel Jue, C.; Regelmann, W.; Stokes, D. C.; Fuchs, H. J.

In: American Journal of Respiratory and Critical Care Medicine, Vol. 153, No. 6 I, 01.07.1996, p. 1914-1917.

Research output: Contribution to journalArticle

Wilmott, RW, Amin, RS, Colin, A, DeVault, A, Dozor, AJ, Eigen, H, Johnson, C, Lester, LA, McCoy, K, McKean, LP, Moss, R, Nash, ML, Pagel Jue, C, Regelmann, W, Stokes, DC & Fuchs, HJ 1996, 'Aerosolized recombinant human DNase in hospitalized cystic fibrosis patients with acute pulmonary exacerbations', American Journal of Respiratory and Critical Care Medicine, vol. 153, no. 6 I, pp. 1914-1917.
Wilmott, R. W. ; Amin, R. S. ; Colin, Andrew ; DeVault, A. ; Dozor, A. J. ; Eigen, H. ; Johnson, C. ; Lester, L. A. ; McCoy, K. ; McKean, L. P. ; Moss, R. ; Nash, M. L. ; Pagel Jue, C. ; Regelmann, W. ; Stokes, D. C. ; Fuchs, H. J. / Aerosolized recombinant human DNase in hospitalized cystic fibrosis patients with acute pulmonary exacerbations. In: American Journal of Respiratory and Critical Care Medicine. 1996 ; Vol. 153, No. 6 I. pp. 1914-1917.
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