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Published ahead of print on May 13, 2003, doi:10.1164/rccm.200209-1093OC

Am. J. Respir. Crit. Care Med., Volume 168, Number 5, September 2003, 588-593

A more recent version of this article appeared on September 1, 2003
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Submitted on September 30, 2002
Accepted on May 12, 2003

COMPOSITE SPIROMETRIC-CT OUTCOME MEASURE IN EARLY CYSTIC FIBROSIS (CF) LUNG DISEASE

Terry E Robinson1*, Ann N Leung2, William H Northway3, Francis G Blankenberg3, Frandics P Chan2, Daniel A Bloch4, Tyson H Holmes4, and Richard B Moss1

1 Pediatric Pulmonology, Stanford University Medical Center, Palo Alto, CA, USA, 2 Radiology, Stanford University Medical Center, Palo Alto, CA, USA, 3 Pediatric Radiology, Stanford University Medical Center, Stanford, CA, USA, 4 Biostatistics HRP, Stanford University Medical Center, Stanford, CA, USA

* To whom correspondence should be addressed. E-mail: ter{at}stanford.edu.

With the advent of therapies aimed at young CF patients with mildly reduced pulmonary function, the need for improved outcome measures which discriminate treatment effects has become important. Pulmonary function measurements or chest HRCT scores have been used to assess interventions. We evaluated these modalities separately and together during a treatment study to develop a more sensitive outcome measure. In a 1 year trial, 25 children randomized to either daily Pulmozyme ®or normal saline aerosol were evaluated at randomization, 3 and 12 months. Outcome variables were PFT results, a global HRCT score, and a composite score incorporating PFTs and HRCT scoring. Regression analyses with generalized estimating equations permitted estimation of the difference in treatment effect between groups over time for each outcome. The largest difference in treatment effects observed at 12 months, measured by the percentage change from baseline, were with the composite total and maximal CT/PFT scores 35.4% and 30.4%), compared to FEF25-75% (13.0%), and total and maximal global HRCT scores (6.2%, 7.2 %). The composite total and maximal CT/PFT scores were the most sensitive outcome measures for discriminating a treatment effect in CF children with normal or mildly reduced pulmonary function during a 1-year trial of Pulmozyme ®.
Key words: cystic fibrosis, composite CT/PFT score, HRCT, pulmonary function




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