Document Detail

Laboratory parameter profiles among patients with cystic fibrosis.
MedLine Citation:
PMID:  16829217     Owner:  NLM     Status:  MEDLINE    
BACKGROUND: Clinical trials in cystic fibrosis (CF) currently use laboratory-specific reference ranges to evaluate chemistry and hematology measurements. Laboratory-specific normal reference ranges may not accurately reflect what is abnormal but clinically insignificant among CF patients. METHODS: To address this concern, data from the Phase III trial of inhaled tobramycin in CF patients was used to describe the distribution and variability of laboratory parameters. The laboratory specimens were analyzed at a central laboratory after being obtained at baseline and throughout the 24-week trial. RESULTS: At the time of entry into the clinical trial, 91% (463 of 508) of patients had at least a single value outside the normal range. Liver function tests (AST, ALT) were above the normal range in 16% and 12% of the patients respectively, with 2.4% of patients having an AST>2.0 times the upper limit of normal. Of the 243 patients on placebo, 242 (99.6%) had at least one laboratory parameter that changed from normal to abnormal during the 24-week follow-up period. Of those same placebo patients, 11.5% (N=28) had a laboratory parameter change from a Common Toxicity Criteria (CTC) grade 0 to grade 2 or higher during follow-up. CONCLUSIONS: Patients with CF frequently have laboratory values outside the normal range and have significant longitudinal variability of laboratory values. Interpretation of adverse events in the clinical trial setting may be complicated by the underlying high rates of some laboratory abnormalities in the CF population. This data was presented in poster format at the American Thoracic Society International Conference, Atlanta, USA, 2002, appearing subsequently in the Conference proceedings [Goss CH, Mayer-Hamblett N, Yunker A, Waltz DA, Kronmal RA, Ramsey BW. Laboratory parameter profiles among patients with cystic fibrosis. Am J Rep Crit Care Med 2002;165(8):A283].
Christopher H Goss; Nicole Mayer-Hamblett; Richard A Kronmal; Judy Williams; Bonnie W Ramsey
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Publication Detail:
Type:  Journal Article; Multicenter Study; Research Support, N.I.H., Extramural; Research Support, Non-U.S. Gov't     Date:  2006-07-07
Journal Detail:
Title:  Journal of cystic fibrosis : official journal of the European Cystic Fibrosis Society     Volume:  6     ISSN:  1569-1993     ISO Abbreviation:  J. Cyst. Fibros.     Publication Date:  2007 Apr 
Date Detail:
Created Date:  2007-03-19     Completed Date:  2007-06-19     Revised Date:  2007-11-15    
Medline Journal Info:
Nlm Unique ID:  101128966     Medline TA:  J Cyst Fibros     Country:  Netherlands    
Other Details:
Languages:  eng     Pagination:  117-23     Citation Subset:  IM    
Department of Medicine, University of Washington Medical Center, Seattle, WA 98195, USA.
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MeSH Terms
Alanine Transaminase / metabolism
Anti-Bacterial Agents / therapeutic use*
Aspartate Aminotransferases / metabolism
Clinical Trials, Phase III as Topic
Cross-Sectional Studies
Cystic Fibrosis / therapy*
Cystic Fibrosis Transmembrane Conductance Regulator / genetics,  metabolism
Double-Blind Method
Laboratory Techniques and Procedures
Liver Function Tests
Longitudinal Studies
Reference Values
Tobramycin / therapeutic use*
Grant Support
Reg. No./Substance:
0/Anti-Bacterial Agents; 0/CFTR protein, human; 0/Placebos; 126880-72-6/Cystic Fibrosis Transmembrane Conductance Regulator; 32986-56-4/Tobramycin; EC Aminotransferases; EC Transaminase

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