Study of Denufosol Inhalation Solution in Patients With Mild Cystic Fibrosis Lung Disease

Phase 3 Completed 352 enrolled Merck Sharp & Dohme LLC

RandomizedParallel-groupDouble-blindTreatment

Summary

The purpose of this trial is to evaluate the safety and effectiveness of a one dose strength of denufosol compared to placebo in patients with mild CF lung disease.

Timeline

Start: 2006-07
Primary completion: 2008-09
Completion: 2008-09

Outcome

Met primary endpoint

paper FEV(1) (primary efficacy endpoint) was 0.048 L for denufosol (n = 178) and 0.003 L for placebo (n = 174; P = 0.047). PMID 21169471 ↗

Publications

Accurso FJ, Moss RB, Wilmott RW, Anbar RD, Schaberg AE, Durham TA, Ramsey BW; TIGER-1 Investigator Study Group. Denufosol tetrasodium in patients with cystic fibrosis and normal to mildly impaired lung function. Am J Respir Crit Care Med. 2011 Mar 1;183(5):627-34. doi: 10.1164/rccm.201008-1267OC. Epub 2010 Dec 17.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	denufosol	Other / unclassified	60 mg	Inhaled