Standardized procedure for measurement of nasal potential difference: An outcome measure in multicenter cystic fibrosis clinical trials
- 13 April 2004
- journal article
- research article
- Published by Wiley in Pediatric Pulmonology
- Vol. 37 (5) , 385-392
- https://doi.org/10.1002/ppul.10448
Abstract
Patients with cystic fibrosis (CF) can be discriminated from healthy subjects by measurement of the nasal potential difference, which has become a useful outcome measure for therapies directed toward correcting defective electrolyte transport in CF. A standard operating procedure was developed by a CF Foundation clinical trials network, to be followed by all sites performing collaborative studies. Key variables in the measurement included type of voltmeter, exploring probe, reference electrodes, and solutions used to assess both sodium transport and chloride conductance. Eight sites submitted data on 3–8 normal and 4–5 CF subjects. Baseline voltage, an index of sodium transport, was −18.2 ± 8.3 mV (mean ± SD) for normals, and −45.3 ± 11.4 mV for CF patients. There was no CFTR‐mediated chloride secretion in CF subjects, as evidenced by the lack of response to perfusion with zero chloride + beta agonist solutions (+3.2 ± 3.5 mV) vs. that in normals (−23.7 ± 10.2 mV). The standardized nasal potential difference measurement minimizes variability between operators and study sites. Valid and consistent results can be attained with trained operators and attention to technical details. These data demonstrate the procedure to be sufficient for multicenter studies in the CF Foundation network. Pediatr Pulmonol. 2004; 37:385–392. © 2004 Wiely‐Liss, Inc.Keywords
This publication has 27 references indexed in Scilit:
- Safety and Biological Efficacy of a Lipid–CFTR Complex for Gene Transfer in the Nasal Epithelium of Adult Patients with Cystic FibrosisMolecular Therapy, 2000
- The diagnosis of cystic fibrosis: A consensus statementThe Journal of Pediatrics, 1998
- Decreased sodium ion absorption across nasal epithelium of very premature infants with respiratory distress syndromeThe Journal of Pediatrics, 1997
- Modification of Nasal Epithelial Potential Differences of Individuals with Cystic Fibrosis Consequent to Local Administration of a Normal CFTR cDNA Adenovirus Gene Transfer VectorHuman Gene Therapy, 1995
- In Vivo Nasal Potential Difference: Techniques and Protocols for Assessing Efficacy of Gene Transfer in Cystic FibrosisHuman Gene Therapy, 1995
- Gene Therapy for Cystic Fibrosis Using Cationic Liposome Mediated Gene Transfer: A Phase I Trial of Safety and Efficacy in the Nasal Airway. University of Alabama at Birmingham, Birmingham, AlabamaHuman Gene Therapy, 1994
- Nasal application of the cationic liposome DC-Chol:DOPE does not alter ion transport, lung function or bacterial growthEuropean Respiratory Journal, 1994
- Measurement of nasal potential difference in adult cystic fibrosis, Young's syndrome, and bronchiectasis.Thorax, 1987
- Relative ion permeability of normal and cystic fibrosis nasal epithelium.Journal of Clinical Investigation, 1983
- Increased Bioelectric Potential Difference across Respiratory Epithelia in Cystic FibrosisNew England Journal of Medicine, 1981