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Multicenter, open-label study of recombinant human DNase in cystic fibrosis patients with moderate lung disease

1998; Wiley; Volume: 26; Issue: 3 Linguagem: Inglês

10.1002/(sici)1099-0496(199809)26

8755-6863

H. K. Harms, Elias Matouk, G Tournier, H. von der Hardt, P Weller, Luca Romano, Harry Heijerman, Muiris X. FitzGerald, David Richard, Birgitta Strandvik, John Kolbe, Kraemer Richard, H Michalsen,

Neonatal Respiratory Health Research

Pediatric PulmonologyVolume 26, Issue 3 p. 155-161 Original Article Multicenter, open-label study of recombinant human DNase in cystic fibrosis patients with moderate lung disease H. Karsten Harms MD, Corresponding Author H. Karsten Harms MD Kinderspital der Universität München, München, GermanyKinderspital der Universität München, Lindwurmstrasse 4, 80337 Munich, GermanySearch for more papers by this authorElias Matouk MB, ChB, FRCPC, Elias Matouk MB, ChB, FRCPC Montreal Chest Hospital Centre, Quebec, CanadaSearch for more papers by this authorGuy Tournier MD, Guy Tournier MD Hôpital Trousseau, Paris, FranceSearch for more papers by this authorHorst von der Hardt MD, Horst von der Hardt MD Medizinische Hochschule Hannover Kinderklinik, Hannover, GermanySearch for more papers by this authorPeter H. Weller MB, BChir, FRCP, Peter H. Weller MB, BChir, FRCP The Birmingham Children's Hospital, Birmingham, UKSearch for more papers by this authorLuca Romano MD, PhD, Luca Romano MD, PhD Instituto Scientifico G. Gaslini, Genoa, ItalySearch for more papers by this authorHarry G. M. Heijerman MD, PhD, Harry G. M. Heijerman MD, PhD Leyenburg Hospital, The Hague, The NetherlandsSearch for more papers by this authorMuiris X. FitzGerald MD, FRCP, Muiris X. FitzGerald MD, FRCP St Vincent' Hospital, Dublin, IrelandSearch for more papers by this authorDavid Richard DCH, FCP, MMed, David Richard DCH, FCP, MMed Johannesburg General Hospital, Parktown, South AfricaSearch for more papers by this authorBirgitta Strandvik MD, PhD, Birgitta Strandvik MD, PhD East Hospital, Göteborg, SwedenSearch for more papers by this authorJohn Kolbe MB, BS, FRACP, John Kolbe MB, BS, FRACP Green Lane Hospital, Auckland, New ZealandSearch for more papers by this authorRichard Kraemer MD, Richard Kraemer MD Universitäts-Kinderklinik, Bern, SwitzerlandSearch for more papers by this authorHelge Michalsen MD, Helge Michalsen MD Aust-Agder Central Hospital, Arendal, NorwaySearch for more papers by this authorfor the DNase International Study Group., for the DNase International Study Group. See Appendix A for additional members of the DNase International Study Group.Search for more papers by this author H. Karsten Harms MD, Corresponding Author H. Karsten Harms MD Kinderspital der Universität München, München, GermanyKinderspital der Universität München, Lindwurmstrasse 4, 80337 Munich, GermanySearch for more papers by this authorElias Matouk MB, ChB, FRCPC, Elias Matouk MB, ChB, FRCPC Montreal Chest Hospital Centre, Quebec, CanadaSearch for more papers by this authorGuy Tournier MD, Guy Tournier MD Hôpital Trousseau, Paris, FranceSearch for more papers by this authorHorst von der Hardt MD, Horst von der Hardt MD Medizinische Hochschule Hannover Kinderklinik, Hannover, GermanySearch for more papers by this authorPeter H. Weller MB, BChir, FRCP, Peter H. Weller MB, BChir, FRCP The Birmingham Children's Hospital, Birmingham, UKSearch for more papers by this authorLuca Romano MD, PhD, Luca Romano MD, PhD Instituto Scientifico G. Gaslini, Genoa, ItalySearch for more papers by this authorHarry G. M. Heijerman MD, PhD, Harry G. M. Heijerman MD, PhD Leyenburg Hospital, The Hague, The NetherlandsSearch for more papers by this authorMuiris X. FitzGerald MD, FRCP, Muiris X. FitzGerald MD, FRCP St Vincent' Hospital, Dublin, IrelandSearch for more papers by this authorDavid Richard DCH, FCP, MMed, David Richard DCH, FCP, MMed Johannesburg General Hospital, Parktown, South AfricaSearch for more papers by this authorBirgitta Strandvik MD, PhD, Birgitta Strandvik MD, PhD East Hospital, Göteborg, SwedenSearch for more papers by this authorJohn Kolbe MB, BS, FRACP, John Kolbe MB, BS, FRACP Green Lane Hospital, Auckland, New ZealandSearch for more papers by this authorRichard Kraemer MD, Richard Kraemer MD Universitäts-Kinderklinik, Bern, SwitzerlandSearch for more papers by this authorHelge Michalsen MD, Helge Michalsen MD Aust-Agder Central Hospital, Arendal, NorwaySearch for more papers by this authorfor the DNase International Study Group., for the DNase International Study Group. See Appendix A for additional members of the DNase International Study Group.Search for more papers by this author First published: 07 December 1998 https://doi.org/10.1002/(SICI)1099-0496(199809)26:3 3.0.CO;2-KCitations: 14 AboutPDF ToolsRequest permissionExport citationAdd to favoritesTrack citation ShareShare Give accessShare full text accessShare full-text accessPlease review our Terms and Conditions of Use and check box below to share full-text version of article.I have read and accept the Wiley Online Library Terms and Conditions of UseShareable LinkUse the link below to share a full-text version of this article with your friends and colleagues. Learn more.Copy URL Share a linkShare onFacebookTwitterLinked InRedditWechat Abstract Cystic fibrosis is characterized by the accumulation of thick viscous purulent secretions. Recombinant human deoxyribonuclease I (rhDNase) breaks down extracellular DNA, which contributes to the increased viscosity of sputum. A multinational, open-label study was conducted in 974 cystic fibrosis patients with moderate lung disease [forced vital capacity (FVC) 40–70% of predicted values] to examine the safety and efficacy of aerosolized rhDNase, 2.5 mg, once daily over a period of at least 12 weeks. Patients were assessed under conditions reflecting routine clinical practice. During rhDNase therapy, at least one respiratory tract infection (RTI) requiring intravenous antibiotics was experienced by 29.5% of patients. Forced expiratory volume in 1 second (FEV1) and FVC were significantly improved from baseline by a mean of 10.5% and 7.2%, respectively. Voice alteration and pharyngitis were the most frequent rhDNase-related adverse events, but only 2% of all patients discontinued treatment due to adverse events. The results obtained were similar to a subanalysis of data from the first 3 months of a placebo-controlled U.S. study. The patients in the present study had a similar frequency of RTIs and improvement in pulmonary function, and reported fewer rhDNase-related and cystic fibrosis–related adverse events than patients in the U.S. study. We conclude that administration of rhDNase is safe, well tolerated, and effective under conditions reflecting routine clinical practice in patients with cystic fibrosis and moderate lung disease. Pediatr Pulmonol. 1998;26:155–161. © 1998 Wiley-Liss, Inc. Citing Literature Volume26, Issue3September 1998Pages 155-161 RelatedInformation