Chest
Original Research: COPDCilomilast for COPD: Results of a 6-Month, Placebo-Controlled Study of a Potent, Selective Inhibitor of Phosphodiesterase 4
Section snippets
Study Design
This was a randomized double-blind, placebo-controlled, parallel-group study conducted from November 1998 to March 2000 at 102 centers located in Canada, Mexico, and the United States (protocol 039). The local ethics committee or institutional review board at each center approved the study protocol, and all subjects gave their informed written consent to participate.
Subjects were evaluated for eligibility at the screening visit. During the 4-week, single-blind, placebo run-in period, subjects
Baseline Characteristics
Baseline characteristics of the placebo and treatment groups are shown in Table 1. The two groups were generally well matched for baseline disease characteristics and demography with the exception that significantly more women were randomized to the cilomilast group. Consequently, baseline FEV1 was higher in the placebo group compared to the cilomilast group; however, when FEV1 was expressed as percentage of predicted, no differences were observed. Percentages of predicted FEV1 values were
Discussion
This was the first large, well-controlled study evaluating cilomilast, a novel PDE-4 inhibitor, in subjects with COPD. This 24-week study corroborated the improvements in lung function and health status that had been observed in a 6-week dose-ranging study.26
In cilomilast-treated subjects, the trough FEV1 was maintained throughout the 24-week treatment period, whereas subjects who had been treated with placebo demonstrated a progressive decrease. In a population of COPD subjects whose
Participating Investigators
R. Abboud, MD, Vancouver, BC; J. Allison, MD, Columbia, SC; S. Amill-Acosta, MD, San Juan, PR; N. Anthonisen, MD, Winnipeg, MB; W. Bailey, MD, Birmingham, AL; M. Baltzan, MD, Cote St. Luc, PQ; V. Bandi, MD, Houston, TX; E. Bleecker, MD, Winston-Salem, NC; H. Blumberg, MD, St. Petersburg, FL; B. Bowlind, MD, Endwell, NY; T. Bruya, MD, Spokane, WA; W. Calhoun, MD, Pittsburgh, PA; F. Candal, MD, Slidell, LA; M. Castro, MD, St. Louis, MO; K. Chapman, MD, Toronto, ON; S. Chodosh, MD, Boston, MA; M.
ACKNOWLEDGMENT
We thank Kate Knobil, Colin Reisner, and Jin Zhu for assistance with analyzing and interpreting the data in this study. We would also like to thank Kim Poinsett-Holmes and Christy Brown for their assistance with manuscript preparation.
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Reproduction of this article is prohibited without written permission from the American College of Chest Physicians (www.chestjournal.org/misc/reprints.shtml).
Dr. Rennard is a member of the speaker’s bureau and a consultant for GlaxoSmithKline, and has received research grants from GlaxoSmithKline. He is a member of the speaker’s bureau, serves as a consultant or has received research grants from Centocor, Novartis, Pfizer, Sanofi, Schering-Plough, Altana, and AstraZeneca. Dr. Schachter is a member of the speaker’s bureau for GlaxoSmithKline, Boehringer Ingleheim, and Novartis, and has received research grants from GlaxoSmithKline. Dr. Strek has received research grants from GlaxoSmithKline. Dr. Rickard and Dr. Amit are employees of GlaxoSmithKline.
This study was funded by a grant from GlaxoSmithKline.