Pilot Study of Tetomilast in Chronic Obstructive Pulmonary Disease (COPD) Associated With Emphysema

Summary

Phase 2a multicenter, randomized, double-blind, placebo-controlled study to assess the pharmacodynamics, efficacy, and safety of tetomilast in patients with emphysema.

Timeline

Start

2009-03

Primary completion

2015-07

Completion

2015-08

Outcome

Missed primary endpoint

Stopped: “Sponsor Terminated”

registry Tetomilast 50 mg vs Placebo; p = 0.1761; Mean Difference (Final Values) 0.0824 (95% CI -0.0378 to 0.2025) NCT00874497 ↗

registry Tetomilast 50 mg vs Placebo; p = 0.139; Mean Difference (Final Values) -2.904 (95% CI -6.77 to 0.97); ANCOVA NCT00874497 ↗

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Tetomilast	Small molecule	50 mg	Oral

Indications