TNF-alpha Antagonists for AECOPD: A Randomized, Double-Blind, Placebo-Controlled Pilot Trial

Summary

The purpose of this study is to determine whether treatment with antibiotics plus a TNFalpha antagonist will provide more effective treatment for acute COPD exacerbation compared to the current standard treatment of antibiotics plus prednisone.

Timeline

Start

2008-11

Primary completion

2011-08

Completion

2011-10

Outcome

Missed primary endpoint

paper The mean between-treatment difference was 4.9% (95% CI -10.3% to 20.2%), p=0.52. PMID 23161645 ↗

paper Etanercept was not more effective than prednisone for treatment of acute exacerbations of COPD. PMID 23161645 ↗

Publications

• Aaron SD, Vandemheen KL, Maltais F, Field SK, Sin DD, Bourbeau J, Marciniuk DD, FitzGerald JM, Nair P, Mallick R. TNFalpha antagonists for acute exacerbations of COPD: a randomised double-blind controlled trial. Thorax. 2013 Feb;68(2):142-8. doi: 10.1136/thoraxjnl-2012-202432. Epub 2012 Nov 17.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Etanercept	Protein / enzyme biologic	50 mg	Subcutaneous
Comparator	Prednisone	Other / unclassified	40 mg	Oral
Background	Levofloxacin	Small molecule	750 mg	Oral

Indications