RW Wilmott, RS Amin, AA Colin, A DeVault, AJ Dozor, H Eigen, C Johnson, LA Lester, K McCoy, LP McKean, R Moss, ML Nash, CP Jue, W Regelmann, DC Stokes and HJ Fuchs
Division of Pulmonary Medicine, Children's Hospital Medical Center, Cincinnati, Ohio 45229-3039, USA.

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) > or = 35% of predicted and an oxygen saturation > or = 90% on a fraction of inspired oxygen (FIO2) < 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.

This article has been cited by other articles:

				P. A. Flume, B. P. O'Sullivan, K. A. Robinson, C. H. Goss, P. J. Mogayzel Jr., D. B. Willey-Courand, J. Bujan, J. Finder, M. Lester, L. Quittell, et al. Cystic Fibrosis Pulmonary Guidelines: Chronic Medications for Maintenance of Lung Health Am. J. Respir. Crit. Care Med., November 15, 2007; 176(10): 957 - 969. [Abstract] [Full Text] [PDF]

				B. K. Rubin Emerging Therapies for Cystic Fibrosis Lung Disease Chest, April 1, 1999; 115(4): 1120 - 1126. [Full Text] [PDF]

				J C Davis Jr, S Manzi, C Yarboro, J Rairie, I Mcinnes, D Averthelyi, D Sinicropi, V G Hale, J Balow, H Austin, et al. Recombinant human Dnase I (rhDNase) in patients with lupus nephritis Lupus, January 1, 1999; 8(1): 68 - 76. [Abstract] [PDF]

				J A. INNES DNase in cystic fibrosis: the challenge of assessing response and maximising benefit Thorax, December 1, 1998; 53(12): 1003 - 1004. [Full Text]

				J.-M. ZAHM, C. GALABERT, A. CHAFFIN, J.-P. CHAZALETTE, C. GROSSKOPF, and E. PUCHELLE Improvement of Cystic Fibrosis Airway Mucus Transportability by Recombinant Human DNase Is Related to Changes in Phospholipid Profile Am. J. Respir. Crit. Care Med., June 1, 1998; 157(6): 1779 - 1784. [Abstract] [Full Text] [PDF]