Effect of Roflumilast on Exacerbation Rate in Patients With Chronic Obstructive Pulmonary Disease. Ratio-Study. (BY217/M2-112)

Summary

The purpose of this study is to investigate the effect of 500mcg roflumilast vs placebo on exacerbation rate and pulmonary function as well as quality of life in patients with chronic obstructive pulmonary disease (COPD).

Timeline

Start

2003-01

Primary completion

—

Completion

—

Outcome

Missed primary endpoint

paper treatment with roflumilast reduced the rate of exacerbations; however, the reduction did not reach statistical significance. PMID 28419462 ↗

Publications

• Facius A, Krause A, Claret L, Bruno R, Lahu G. Modeling and Simulation of Pivotal Clinical Trials Using Linked Models for Multiple Endpoints in Chronic Obstructive Pulmonary Disease With Roflumilast. J Clin Pharmacol. 2017 Aug;57(8):1042-1052. doi: 10.1002/jcph.885. Epub 2017 Apr 17.
• Rennard SI, Calverley PM, Goehring UM, Bredenbroker D, Martinez FJ. Reduction of exacerbations by the PDE4 inhibitor roflumilast--the importance of defining different subsets of patients with COPD. Respir Res. 2011 Jan 27;12(1):18. doi: 10.1186/1465-9921-12-18.

Drugs

Indications