Document Detail


Clinical trials of recombinant human DNase in cystic fibrosis patients.
MedLine Citation:
PMID:  8124306     Owner:  NLM     Status:  MEDLINE    
Abstract/OtherAbstract:
Respiratory disease in cystic fibrosis (CF) patients is characterized by purulent secretions in the airways, recurrent respiratory infections and progressive deterioration of lung function. Sputum from CF patients has a high concentration of DNA which is released by dead leukocytes. DNA is a contributor to the viscoelastic properties of sputum. Recombinant human DNase has been shown to decrease the viscoelastic properties of respiratory secretions of patients with CF in vitro. This article outlines the phase 1, 2 and 3 trial of rhDNase that have been performed in the UK and in the US. The largest of these trials, the phase 3 trial, involved 968 patients over a 24 week period. There was improvement in FEV1 by 6% in the patients receiving rhDNase. Compared to placebo controlled patients, patients given aerosolized rhDNase spent 1.2-1.4 less days in hospital and had 2.4-2.7 fewer days of antibiotic treatment. There was no evidence of an asthmatic response. There was an increased incidence of voice alteration in the rhDNase groups (16% and 12% compared to 7%). An antibody response was seen in up to 5% in the rhDNase patients over the 24 week period, although this appeared to be without any clinical effect. In conclusion, the clinical trials of aerosolized rhDNase show that it appears safe, improves spirometry, and reduces the need for antibiotic treatment for acute exacerbations of the pulmonary disease of CF.
Authors:
M L Aitken
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Publication Detail:
Type:  Journal Article; Research Support, Non-U.S. Gov't    
Journal Detail:
Title:  Monaldi archives for chest disease = Archivio Monaldi per le malattie del torace / Fondazione clinica del lavoro, IRCCS [and] Istituto di clinica tisiologica e malattie apparato respiratorio, Università di Napoli, Secondo ateneo     Volume:  48     ISSN:  1122-0643     ISO Abbreviation:  Monaldi Arch Chest Dis     Publication Date:  1993 Dec 
Date Detail:
Created Date:  1994-04-13     Completed Date:  1994-04-13     Revised Date:  2008-06-02    
Medline Journal Info:
Nlm Unique ID:  9307314     Medline TA:  Monaldi Arch Chest Dis     Country:  ITALY    
Other Details:
Languages:  eng     Pagination:  653-6     Citation Subset:  IM    
Affiliation:
Dept of Medicine, University of Washington, Seattle 98195.
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MeSH Terms
Descriptor/Qualifier:
Adolescent
Adult
Child
Clinical Trials as Topic
Cystic Fibrosis / therapy*
Deoxyribonuclease I / therapeutic use*
Expectorants / therapeutic use*
Female
Humans
Male
Middle Aged
Recombinant Proteins / therapeutic use
Chemical
Reg. No./Substance:
0/Expectorants; 0/Recombinant Proteins; EC 3.1.21.1/DNASE1 protein, human; EC 3.1.21.1/Deoxyribonuclease I

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