Effect of BIBW 2948 BS in COPD

NCT00423137 ↗

Phase 2 Completed 48 enrolled Boehringer Ingelheim

RandomizedParallel-groupQuadruple-blindTreatment

Summary

Study of BIBW 2948 BS in Patients with COPD and Chronic Bronchitis

Timeline

Start: 2007-01-17
Primary completion: 2008-07-09
Completion: 2008-07-09

Outcome

Missed primary endpoint

registry analysis (other test); Placebo Total vs BIBW2948 Total; p = 0.5305; Difference of least square means -1.385; ANCOVA NCT00423137 ↗

paper Four-week treatment with BIBW 2948 did not significantly decrease epithelial mucin stores and was poorly tolerated in patients with COPD. PMID 20007923 ↗

Publications

Woodruff PG, Wolff M, Hohlfeld JM, Krug N, Dransfield MT, Sutherland ER, Criner GJ, Kim V, Prasse A, Nivens MC, Tetzlaff K, Heilker R, Fahy JV. Safety and efficacy of an inhaled epidermal growth factor receptor inhibitor (BIBW 2948 BS) in chronic obstructive pulmonary disease. Am J Respir Crit Care Med. 2010 Mar 1;181(5):438-45. doi: 10.1164/rccm.200909-1415OC. Epub 2009 Dec 10.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	BIBW 2948	Unknown	15 mg	Inhaled
Subject	BIBW 2948	Unknown	30 mg	Inhaled