PMID: 8586138Oct 1, 1995Paper

DNase trials in cystic fibrosis

The European Respiratory Journal
M E Hodson, P L Shah

Abstract

Cystic fibrosis (CF) is a disease with a high morbidity and mortality from pulmonary disease. Sputum from CF patients contains high levels of deoxyribonucleic acid (DNA), which contribute to its viscoelasticity. Recombinant deoxyribonuclease (rhDNase) has been developed and in vitro studies have showed reduction in the viscoelasticity of CF sputum. This article reviews the in vivo clinical trials conducted to determine the safety and efficacy of this treatment. Phase 1 studies showed preliminary safety data and some evidence of clinical benefit. The two Phase 2 short-term studies showed improvement in pulmonary function and important safety data. The Phase 3 study, which included 968 patients, showed improvement in forced expiratory volume in one second (FEV1) of 5.8% and 5.6% in patients treated once and twice daily, respectively. The risk of developing an exacerbation of infection was reduced by 28% with once daily and 37% with twice daily treatment, compared to placebo. The drug was safe and there was some improvement in quality of life data. Longer-term open labelled studies, the results of intermittent administration, administration to severely ill patients, and the use of different delivery systems are reviewed. In conclu...Continue Reading

Citations

Sep 9, 2011·Current Opinion in Pediatrics·Frederick H Royce, John C Carl
Dec 20, 2003·American Journal of Respiratory and Critical Care Medicine·Karl PaulUNKNOWN Bronchoalveolar Lavage for the Evaluation of Antiinflammatory Treatment Study Group
Nov 18, 2003·Reproductive Biology and Endocrinology : RB&E·Ralf R Henkel, Wolf-Bernhard Schill
Aug 21, 2013·American Journal of Respiratory and Critical Care Medicine·Alice V DuboisVirginie Hervé
Jan 1, 1997·Pediatric Pulmonology. Supplement·M E Hodson
Mar 20, 2004·Pediatric Pulmonology. Supplement·Felix Ratjen
Jul 12, 2014·Arteriosclerosis, Thrombosis, and Vascular Biology·Travis J GouldPatricia C Liaw
Jun 6, 2003·Diabetic Medicine : a Journal of the British Diabetic Association·A D R MackieF P Edenborough

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