drugset / Trial / NCT02177344

Safety and Efficacy of Two Different Doses of Ipratropium Bromide Versus ATROVENT® Inhalation Aerosol in Adults With Chronic Obstructive Pulmonary Disease

NCT02177344

Phase 3 Completed 646 enrolled Boehringer Ingelheim
RandomizedParallel-groupDouble-blindTreatment

Summary

The objective of this study is to confirm that chronic dosing of 20 mcg and 40 mcg of ipratropium bromide, administered via the RESPIMAT device, demonstrates clinical comparability and similar safety profiles to the 36 mcg dose of ATROVENT® Inhalation Aerosol (containing chlorinated fluorocarbons (CFC)) in patients with chronic obstructive pulmonary disease (COPD). The efficacy and safety profiles of the two doses administered via the RESPIMAT device will also be compared to their respective placebo groups

Timeline

Start
1998-08
Primary completion
1999-10
Completion

Drugs

EvaluationDrugModalityDoseRoute
Subject Ipratropium Small molecule 20 ug Inhaled
Subject Ipratropium Small molecule 36 ug Inhaled
Subject Ipratropium Small molecule 40 ug Inhaled