A Study of Tobramycin Inhalation Powder From a Modified Manufacturing Process Versus Placebo

Phase 3 Completed 62 enrolled Novartis Pharmaceuticals

RandomizedParallel-groupTriple-blindTreatment

Summary

This study is designed to show how well tobramycin inhalation powder works and how safe it is when produced by a modified manufacturing process

Timeline

Start: 2009-06
Primary completion: 2011-05
Completion: 2011-05

Outcome

Missed primary endpoint

paper Mean treatment differences (TIP - placebo) were 5.9% (p=0.148) and 4.4% (p<0.05) for relative and absolute change in FEV₁% predicted respectively. PMID 23672633 ↗

paper Relative change in FEV₁% predicted with TIP treatment was in the expected range based on the literature, but did not reach statistical significance versus placebo. PMID 23672633 ↗

Publications

Galeva I, Konstan MW, Higgins M, Angyalosi G, Brockhaus F, Piggott S, Thomas K, Chuchalin AG. Tobramycin inhalation powder manufactured by improved process in cystic fibrosis: the randomized EDIT trial. Curr Med Res Opin. 2013 Aug;29(8):947-56. doi: 10.1185/03007995.2013.805122. Epub 2013 Jun 5.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Tobramycin	Unknown	112 mg	Inhaled