ipratropium/albuterol

Evidence outlook · lead readout

NCT00588406 · Asthma

The lead readout missed its primary endpoint. The grade and rationale below record what the trial was designed to show and what it found.

NCT00588406: This was a randomized, triple-blind, placebo-controlled trial of 95 adults with acute asthma in the emergency room, comparing nebulized budesonide added to standard therapy (albuterol, ipratropium, prednisone) versus placebo plus the same standard therapy. The primary endpoint, FEV1 percent predicted at 4 hours, was not met: the budesonide arm reached 51.7% versus 52.6% in the placebo arm, with no statistical analysis reported, and secondary hospitalization rates were identical. Because ipratropium/albuterol was administered as background therapy in both arms, this trial does not provide direct evidence for that drug.