Abstract | BACKGROUND: METHODS: ARTEMIS-IPF was a randomised, double-blind, placebo-controlled, multicentre, phase 3 trial of ambrisentan for adults aged 40-80 years with well-defined idiopathic pulmonary fibrosis and 5% or less honeycombing on high-resolution CT. In December, 2010, an interim analysis showed lack of efficacy and the trial was stopped. In the present follow-on analysis, we assessed patients who were screened for ARTEMIS-IPF who underwent high-resolution CT as part of screening and surgical lung biopsy as part of standard clinical care. A radiologist and a pathologist from a central panel independently assessed anonymised CT scans and biopsy samples. We calculated the positive and negative predictive value of high-resolution CT (classified as usual interstitial pneumonia, possible usual interstitial pneumonia, and inconsistent with usual interstitial pneumonia) for confirmation of histological patterns of usual interstitial pneumonia. This study is registered with ClinicalTrials.gov, number NCT00768300. FINDINGS: INTERPRETATION: FUNDING: Gilead Sciences.
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Authors | Ganesh Raghu, David Lynch, J David Godwin, Richard Webb, Thomas V Colby, Kevin O Leslie, Juergen Behr, Kevin K Brown, James J Egan, Kevin R Flaherty, Fernando J Martinez, Athol U Wells, Lixin Shao, Huafeng Zhou, Patricia S Pedersen, Rohit Sood, A Bruce Montgomery, Thomas G O'Riordan |
Journal | The Lancet. Respiratory medicine
(Lancet Respir Med)
Vol. 2
Issue 4
Pg. 277-84
(Apr 2014)
ISSN: 2213-2619 [Electronic] England |
PMID | 24717624
(Publication Type: Journal Article, Research Support, Non-U.S. Gov't)
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Copyright | Copyright © 2014 Elsevier Ltd. All rights reserved. |
Topics |
- Adult
- Aged
- Aged, 80 and over
- Biopsy
- Clinical Trials, Phase III as Topic
- Diagnosis, Differential
- Double-Blind Method
- Female
- Humans
- Idiopathic Pulmonary Fibrosis
(diagnostic imaging, pathology)
- Male
- Middle Aged
- Multicenter Studies as Topic
- Randomized Controlled Trials as Topic
- Tomography, X-Ray Computed
(methods)
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