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ATS 2009 · San Diego
International Conference
Abstract Number: 5158
Contact/Presenting Author: Paul Noble
Department/Institution:  Duke University Medical Center
Address:  106 Research Drive, DUMC Box 103000
City/State/Zip/Country:  Durham, NC, 27710
Phone: (919) 681-0355   Fax:   E-mail:  paul.noble@duke.edu
ATS member: Yes   Student or in training: No
Funding Source: InterMune, Inc.

Abstract Category: 09.21 - Interstitial Lung Disease
Presentation format: Either Poster or Oral
Preview Disclosure
Travel Award: No
Publication of email address: No

I confirm that all authors listed on this abstract have knowledge of the abstract submission: Yes


Title: The CAPACITY (CAP) Trials: Randomized, Double-Blind, Placebo-Controlled, Phase III Trials of Pirfenidone (PFD) in Patients with Idiopathic Pulmonary Fibrosis (IPF)

P. Noble1, C. Albera2, W. Bradford3, U. Costabel4, D. Kardatzke3, T. King, Jr5, S. Sahn6, J. Szwarcberg3, D. Valeyre7 and R. du Bois8. 1Duke University, Durham, NC; 2University of Turin, Italy; 3InterMune, Inc., Brisbane, CA; 4Ruhrlandklinik, Essen, Germany; 5UCSF, San Francisco, CA; 6MUSC, Charleston, SC; 7Assistance Publique-Hôpitaux, Paris, France and 8National Jewish, Denver, CO.

Introduction: PFD is an oral antifibrotic agent shown in trials in Japan to be safe and efficacious in IPF patients. CAP I and II are global registration trials conducted concurrently to further assess the safety and efficacy of PFD in IPF patients.
Methods: Patients were randomized to receive PFD or placebo (PBO) TID until 72 weeks after the last patient enrolled. In CAP I, patients received PFD 2403 mg/d or PBO; in CAP II, patients received PFD 2403 mg/d, PFD 1197 mg/d, or PBO. Eligibility criteria included a confident clinical and radiologic diagnosis, FVC 50%, and DLco 35%. The primary endpoint was change in % FVC at Wk 72.
Results: A total of 779 patients (CAP I: 344, CAP II: 435) were enrolled at 110 sites in 11 countries. Treatment is complete, but only blinded, preliminary data are available. Most patients were Caucasian, male, and the mean age was 66. HRCT scans met criteria for definite IPF in > 90% of patients; all others had a diagnostic biopsy. Over 97% of surviving, transplant-free patients completed the Wk 72 Visit.
Conclusions: CAP I and II are robust, global Phase III trials to assess the safety and efficacy of PFD in IPF patients. Preliminary blinded results demonstrate successful enrollment of the target population and extremely high rates of patient retention. Final study results will be presented.

Demographic and Basline Characteristics
CAP I (N=344)CAP II (N=435)
Mean Age (years)66.966.4
Male (%)71.871.5
Caucasian (%)98.896.3
Mean A-a gradient (mm Hg)17.117.7
Mean % FVC74.075.6
Mean % DLCO47.646.4
Definite IPF on HRCT (%)89.293.6