Respimat® Combivent Trial in Chronic Obstructive Pulmonary Disease (COPD)

Summary

The primary objective of this study is to compare the effect of ipratropium bromide/salbutamol inhalation spray combination administered by the Respimat® inhaler (20 mcg/100 mcg), ipratropium bromide inhalation spray administered by the Respimat® inhaler (20 mcg), and COMBIVENT® MDI administered q.i.d on FEV1 at intervals over a treatment period of 12 weeks in patients with COPD. Specifically, non-inferiority of Combivent Respimat® to COMBIVENT® MDI in FEV1 AUC from 0 to 6 hours , superiority of Combivent Respimat® to Atrovent Respimat® monotherapy in FEV1 AUC from 0 to 4 hours, and non-inferiority of Combivent Respimat® to Atrovent Respimat® monotherapy in FEV1 AUC from 4 to 6 hours will be analyzed. In addition, steady state pharmacokinetics over one dosing interval following 4 weeks of therapy will be characterized in a subgroup of patients.

Timeline

Start

2006-11

Primary completion

2008-04

Completion

—

Publications

• Zuwallack R, De Salvo MC, Kaelin T, Bateman ED, Park CS, Abrahams R, Fakih F, Sachs P, Pudi K, Zhao Y, Wood CC; Combivent Respimat Inhaler Study Group. Efficacy and safety of ipratropium bromide/albuterol delivered via Respimat inhaler versus MDI. Respir Med. 2010 Aug;104(8):1179-88. doi: 10.1016/j.rmed.2010.01.017. Epub 2010 Feb 20.

Drugs

Indications