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July 21, 2004

Inhaled Nitric Oxide in Acute Lung Injury—Reply

Author Affiliations

Letters Section Editor: Stephen J. Lurie, MD, PhD, Senior Editor.

JAMA. 2004;292(3):327. doi:10.1001/jama.292.3.327-b

In Reply: In response to Dr Kaisers and colleagues, there had been only 2 other large published studies of inhaled nitric oxide in patients with ARDS.1,2 The first of these studies was halted early. It enrolled only patients who increased their oxygenation status when challenged with inhaled nitric oxide prior to enrollment. In that trial, the number of patients with improved signs of acute lung injury was not statistically different between the 2 treatment groups, the primary end point of the trial. The design of our 2 trials was different in that all patients were randomized and response status was not established. Our first study was a phase 2 study that was designed to ascertain safety and potentially link a dose effect to clinical outcome in patients with ARDS. A post-hoc analysis suggested that there was a clinical benefit of inhaled nitric oxide at 5 ppm among this group of patients. To test this hypothesis, our phase 3 study was completed, which we believe was appropriate and needed.