Modulation of Lung Injury Complicating Lung Resection

Phase 2 Completed 52 enrolled Imperial College London Royal Brompton & Harefield NHS Foundation Trust · collab Royal College of Physicians · collab

RandomizedParallel-groupQuadruple-blindPrevention

Summary

The purpose of this study is to determine whether N-acetylcysteine given intravenously 1 day pre-operatively is effective in preventing inflammation in the lungs, as measured by tests on blood, breath and lung specimens, in patients undergoing surgery to remove a portion of lung.

Timeline

Start: 2007-08
Primary completion: 2009-07
Completion: 2009-07

Outcome

Missed primary endpoint

registry analysis (superiority test); N-acetylcysteine vs Placebo; p = 0.09; t-test, 2 sided NCT00655928 ↗

Publications

Results Bastin AJ, Davies N, Lim E, Quinlan GJ, Griffiths MJ. Systemic inflammation and oxidative stress post-lung resection: Effect of pretreatment with N-acetylcysteine. Respirology. 2016 Jan;21(1):180-7. doi: 10.1111/resp.12662. Epub 2015 Oct 27.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	N-acetylcysteine	Small molecule	240 mg/kg	Intravenous