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Original Research: CYSTIC FIBROSIS |

An International Randomized Multicenter Comparison of Nasal Potential Difference Techniques

George M. Solomon, MD; Michael W. Konstan, MD; Michael Wilschanski, MBBS; Joanne Billings, MD, FCCP; Isabelle Sermet-Gaudelus, MD, PhD; Frank Accurso, MD; François Vermeulen, MD; Elina Levin, BS; Heather Hathorne, MAE, RRT; Ginger Reeves, BS, RRT; Gina Sabbatini, BS; Aubrey Hill, PhD; Nicole Mayer-Hamblett, PhD; Melissa Ashlock, MD; John Paul Clancy, MD; Steven M. Rowe, MD
Author and Funding Information

From the University of Alabama at Birmingham (Drs Solomon, Hill, Clancy, and Rowe, and Mss Levin, Hathorne, Reeves, and Sabbatini), Birmingham, AL; Case Western Reserve University (Dr Konstan), Cleveland, OH; Hadassah University Hospitals (Dr Wilschanski), Jerusalem, Israel; the University of Minnesota (Dr Billings), Minneapolis, MN; Hopital Necker Enfants Malades (Dr Sermet-Gaudelus), Université Paris Descartes, Paris, France; the University of Colorado, Denver (Dr Accurso), Aurora, CO; the Department of Pediatrics (Dr Vermeulen), Catholic University of Leuven, Leuven, Belgium; the Department of Pediatrics (Dr Mayer-Hamblett), University of Washington, Seattle, WA; and Cystic Fibrosis Foundation Therapeutics, Inc (Dr Ashlock), Bethesda, MD.

Correspondence to: Steven M. Rowe, MD, University of Alabama at Birmingham, MCLM 768, 1918 University Blvd, Birmingham, AL 35294-0006; e-mail: smrowe@uab.edu


Funding/Support: This research was funded by the US National Institutes of Health [Grants 1K23DK075788-01 and 1R03DK084110-01 (to Dr Rowe) and Grant 1P30DK072482-01A1 (to Eric J. Sorscher)] and the Cystic Fibrosis Foundation [Grants CLANCY05Y2 (Drs Clancy and Rowe) and RAMSEY03Y0 (to the Therapeutics Development Network Coordinating Center)].

Reproduction of this article is prohibited without written permission from the American College of Chest Physicians (http://www.chestpubs.org/site/misc/reprints.xhtml).


© 2010 American College of Chest Physicians


Chest. 2010;138(4):919-928. doi:10.1378/chest.10-0179
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Background:  The transepithelial nasal potential difference (NPD) is used to assess cystic fibrosis transmembrane conductance regulator (CFTR) activity. Unreliability, excessive artifacts, and lack of standardization of current testing systems can compromise its use as a diagnostic test and outcome measure for clinical trials.

Methods:  To determine whether a nonperfusing (agar gel) nasal catheter for NPD measurement is more reliable and less susceptible to artifacts than a continuously perfusing nasal catheter, we performed a multicenter, randomized, crossover trial comparing a standardized NPD protocol using an agar nasal catheter with the same protocol using a continuously perfusing catheter. The data capture technique was identical in both protocols. A total of 26 normal adult subjects underwent NPD testing at six different centers.

Results:  Artifact frequency was reduced by 75% (P < .001), and duration was less pronounced using the agar catheter. The measurement of sodium conductance was similar between the two catheter methods, but the agar catheter demonstrated significantly greater CFTR-dependent hyperpolarization, because Δ zero Cl- + isoproterenol measurements were significantly more hyperpolarized with the agar catheter (224.2 ± 12.9 mV with agar vs 18.2 ± 9.1 mV with perfusion, P < .05).

Conclusions:  The agar nasal catheter approach demonstrates superior reliability compared with the perfusion nasal catheter method for measurement of NPD. This nonperfusion catheter method should be considered for adoption as a standardized protocol to monitor CFTR activity in clinical trials.

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