Clinical Trial to Assess Pharmacodynamic Effects on Segmental Endotoxin Induced Inflammatory Response of BI 1026706 Versus Placebo

Summary

The primary and secondary objectives of the current study are the assessments of anti-inflammatory pharmacodynamic effects on segmental endotoxin induced inflammatory response after 4 weeks treatment with BI 1026706.

Timeline

Start

2016-03-11

Primary completion

2017-02-14

Completion

2017-03-13

Outcome

Missed primary endpoint

registry analysis (equivalence test); Placebo vs BI 1026706; p = 0.3043; Geometric mean ratio (%) 1.27 (90% CI 0.86 to 1.87); ANOVA NCT02657408 ↗

paper There were no significant differences in cells or other biomarkers from BAL in volunteers treated with BI 1026706 compared with those treated with placebo. PMID 37562641 ↗

Publications

• Gress C, Vogel-Claussen J, Badorrek P, Muller M, Hohl K, Konietzke M, Litzenburger T, Seibold W, Gupta A, Hohlfeld JM. The effect of bradykinin 1 receptor antagonist BI 1026706 on pulmonary inflammation after segmental lipopolysaccharide challenge in healthy smokers. Pulm Pharmacol Ther. 2023 Oct;82:102246. doi: 10.1016/j.pupt.2023.102246. Epub 2023 Aug 9.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	BI 1026706	Unknown	100 mg	—

Indications

No indication recorded.